Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Hospitalized Adults With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure (NCT NCT04705597)

Last Updated: 2023-07-03

Results Overview

Proportion of participants who have died or progressed to respiratory failure as defined by progressing to the need for high-flow nasal cannula O2 delivery, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at Day 28. The proportion of participants is represented as a percentage.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

194 participants

Primary outcome timeframe

First dose date up to Day 28

Results posted on

2023-07-03

Participant Flow

Participants were recruited across 3 countries (US, Brazil and Argentina). Participants were hospitalized with a confirmed lab PCR SARS-COV-2 infection. First Subject First Visit was on 26 May 2021 and Last Subject Last Visit was on 19May2022.

There were 223 participants screened for the study. Of these, 194 participants were randomized to received either asapiprant or placebo.

Participant milestones

Participant milestones
Measure	Asapiprant (BGE-175) Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Overall Study STARTED	96	98
Overall Study COMPLETED	78	87
Overall Study NOT COMPLETED	18	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Asapiprant (BGE-175) Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Overall Study Death	16	9
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	2

Baseline Characteristics

Study to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Hospitalized Adults With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days	Total n=194 Participants Total of all reporting groups
Age, Customized Age 50 to less than 75	71 Participants n=5 Participants	71 Participants n=7 Participants	142 Participants n=5 Participants
Age, Customized Age greater or equal to 75	25 Participants n=5 Participants	27 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	43 Participants n=7 Participants	87 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants	55 Participants n=7 Participants	107 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	69 Participants n=5 Participants	68 Participants n=7 Participants	137 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants	30 Participants n=7 Participants	54 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	78 Participants n=5 Participants	85 Participants n=7 Participants	163 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Race · Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment North America	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment South America	75 Participants n=5 Participants	77 Participants n=7 Participants	152 Participants n=5 Participants
Baseline WHO ordinal scale WHO ordinal scale score 3	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Baseline WHO ordinal scale WHO ordinal scale score 4	82 Participants n=5 Participants	91 Participants n=7 Participants	173 Participants n=5 Participants
Baseline WHO ordinal scale WHO ordinal scale score 5	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: First dose date up to Day 28

Population: The Intent-to-Treat (ITT) Analysis Set was used for the primary efficacy analysis and includes all randomized participants.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=94 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=97 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Proportion of Participants Who Have Died or Progressed to Respiratory Failure	31 Participants	26 Participants

SECONDARY outcome

Timeframe: First dose of treatment through study Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Proportion of participants experiencing treatment-emergent adverse events as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. The proportion of participants is represented as a percentage.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Proportion of Participants Experiencing Treatment-emergent Adverse Events	73 Participants	71 Participants

SECONDARY outcome

Timeframe: Baseline through Day 57; at Day 14, Day 28 and Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. Subjects who discontinued the study prior to the timepoint are censored at the date of discontinuation and excluded from the analysis. At Day 57, the number participants analyzed were different because 9 participants were censored from the asapiprant arm and 15 participants from the placebo arm.

Proportion of participants surviving at Day 14, Day 28, and Day 57. The proportion of participants is represented as a percentage.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=94 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=96 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Survival Survival at Day 14	89 Participants	93 Participants
Survival Survival at Day 28	79 Participants	87 Participants
Survival Survival at Day 57	69 Participants	72 Participants

SECONDARY outcome

Timeframe: First dose of treatment through Day 14, Day 28

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Proportion of subjects who survive without progression to respiratory failure at Day 28. The proportion of participants is represented as a percentage.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28 Day 14	69.5 percentage of participants Interval 59.1 to 77.7	78.6 percentage of participants Interval 69.0 to 85.5
Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28 Day 28	67.3 percentage of participants Interval 56.9 to 75.8	73.4 percentage of participants Interval 63.4 to 81.0

SECONDARY outcome

Timeframe: Baseline through Day 28

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Kaplan-Meier Estimate of Time to Two Successive Negative Viral Titers in Nasopharyngeal Swab (median)

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs	29 days Interval 29.0 to At Day 28, there were not enough events therefore the upper limit of 95% CI was unable to be calculated.	29 days Interval 29.0 to At Day 28, there were not enough events therefore the upper limit of 95% CI was unable to be calculated.

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Kaplan-Meier Estimate of Time to Clinical Worsening from Baseline Value. Time to clinical worsening from baseline value (defined by time to ≥ 1-point worsening on World Health Organization (WHO) Ordinal Scale for COVID-19). The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Time to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19)	NA days Median Survival Time was assessed using a Kaplan Meier Estimate with median survival defined as the smallest time at which the survival probability drops to 0.5 (50%) or below. Up to Day 57, the survival rate, for each of the treatment arms and overall, never fell below 50% therefore the median survival time was unable to be calculated. There were insufficient number of participants with events to calculate the lower limit of the 95% confidence interval.	NA days Median Survival Time was assessed using a Kaplan Meier Estimate with median survival defined as the smallest time at which the survival probability drops to 0.5 (50%) or below. Up to Day 57, the survival rate, for each of the treatment arms and overall, never fell below 50% therefore the median survival time was unable to be calculated. There were insufficient number of participants with events to calculate the lower limit of the 95% confidence interval.

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Proportion of patients who develop critical COVID-19 illness as defined by at least one of the following: A. RF defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, ECMO, clinical diagnosis respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) B. Hemodynamic compromise (defined by systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg or requiring vasopressors) C. Multi-organ dysfunction/failure The proportion of participants is represented as a percentage.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Proportion of Patients Who Develop Critical COVID-19 Illness	34 Participants	28 Participants

SECONDARY outcome

Timeframe: First dose date up to Day 28

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Kaplan-Meier Estimate of Time to Clinical Improvement from Baseline Value. Time to clinical improvement defined by time to ≥ 1-point improvement on World Health Organization (WHO) Ordinal Scale for COVID-19 - must be maintained through Day 28. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Time to Clinical Improvement From Baseline Value (Defined by Time to ≥ 1-point Improvement on WHO Ordinal Scale for COVID-19 Score - Must be Maintained Through Day 28)	8 days Interval 6.0 to 10.0	6 days Interval 5.0 to 9.0

SECONDARY outcome

Timeframe: Day 14/End of Treatment, Day 28, Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Mean change from baseline in WHO Ordinal Scale for COVID-19 score World Health Organization (WHO) Ordinal Scale for COVID-19. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death. A higher score means a worse outcome.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score Change at Day 14	-1.2 score on a scale Standard Deviation 2.17	-1.8 score on a scale Standard Deviation 1.76
Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score Change at Day 28	-1.2 score on a scale Standard Deviation 2.51	-1.7 score on a scale Standard Deviation 2.11
Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score Change at Day 57	-2.7 score on a scale Standard Deviation 0.58	-2.8 score on a scale Standard Deviation 0.42

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Proportion of Patients who had Intubation during the study defined as proportion of patients who had any documented intubation during the study.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Number of Patients Who Had Intubation During the Study	18 Participants	10 Participants

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Duration of Intubation (first post-dosing intubation)

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=18 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=10 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Duration of Intubation	11.8 Days Standard Deviation 5.32	7.8 Days Standard Deviation 7.96

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Time from intensive care unit admission to the recorded time of intensive care unit discharge

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=22 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=17 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Time to Discharge From Hospital Intensive Care Unit	15.7 days Standard Deviation 7.67	12.1 days Standard Deviation 8.55

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Proportion of patients who had any documented post-dosing supplemental O2 administration during the study.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Number of Patients Who Had Supplemental Oxygen Administration	86 Participants	92 Participants

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Duration of participants receiving supplemental oxygen

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=86 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=92 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Duration of Supplemental Oxygen Administration	14.7 days Standard Deviation 17	11.7 days Standard Deviation 14.81

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Proportion of patients who had any documented post-dosing noninvasive ventilation or high-flow nasal cannula O2 administration.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration	26 Participants	23 Participants

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Duration of participants receiving noninvasive ventilation by nonrebreather mask or high-flow nasal cannula

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=26 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=23 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula	11.1 days Standard Deviation 13.27	5.4 days Standard Deviation 7

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. This outcome is based on subjects who had WHO ordinal scale score of 6. A subject can have either a score of 6 or 7 (see outcome measure: Duration of Mechanical Ventilation Plus Additional Organ Support) but not both. This is the reason for the differing numbers for outcome 17 and 19.

Proportion of patients who had any documented post-dosing mechanical ventilation.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Number of Patients Who Had Mechanical Ventilation.	9 Participants	10 Participants

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Duration of participants receiving mechanical ventilation

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=9 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=10 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Duration of Mechanical Ventilation	10.9 days Standard Deviation 4.99	7.7 days Standard Deviation 4.88

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants. This outcome is based on subjects who had WHO ordinal scale score of 7. A subject can have either a score of 6 (see outcome measure: Duration of Mechanical Ventilation) or 7 but not both. This is the reason for the differing numbers for outcome 17 and 19.

Proportion of patients who had any documented post-dosing mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Number of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO.	14 Participants	4 Participants

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Duration of participants receiving mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=14 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=4 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Duration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO	8.7 days Standard Deviation 5.85	3 days Standard Deviation 1.41

SECONDARY outcome

Timeframe: First dose date up to Day 28

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Daily ratio of participants' oxygen saturation (SpO2) to fractional inspired O2 (SpO2/FiO2)

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Baseline	2.9 Ratio SpO2/FiO2 Standard Deviation 0.71	3.0 Ratio SpO2/FiO2 Standard Deviation 0.63
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Treatment Day 2	2.7 Ratio SpO2/FiO2 Standard Deviation 0.81	2.9 Ratio SpO2/FiO2 Standard Deviation 0.73
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Treatment Day 3	2.5 Ratio SpO2/FiO2 Standard Deviation 0.92	2.8 Ratio SpO2/FiO2 Standard Deviation 0.75
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Treatment Day 4	2.3 Ratio SpO2/FiO2 Standard Deviation 0.92	2.7 Ratio SpO2/FiO2 Standard Deviation 0.86
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Treatment Day 5	2.3 Ratio SpO2/FiO2 Standard Deviation 0.91	2.6 Ratio SpO2/FiO2 Standard Deviation 0.90
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Treatment Day 6	2.3 Ratio SpO2/FiO2 Standard Deviation 0.89	2.5 Ratio SpO2/FiO2 Standard Deviation 0.90
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Treatment Day 7	2.5 Ratio SpO2/FiO2 Standard Deviation 0.99	2.6 Ratio SpO2/FiO2 Standard Deviation 0.93
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Treatment Day 8	2.4 Ratio SpO2/FiO2 Standard Deviation 0.88	2.7 Ratio SpO2/FiO2 Standard Deviation 0.95
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Treatment Day 9	2.3 Ratio SpO2/FiO2 Standard Deviation 1.02	2.8 Ratio SpO2/FiO2 Standard Deviation 0.95
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Treatment Day 10	2.3 Ratio SpO2/FiO2 Standard Deviation 1.11	2.9 Ratio SpO2/FiO2 Standard Deviation 0.67
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Treatment Day 11	2.4 Ratio SpO2/FiO2 Standard Deviation 1.10	2.8 Ratio SpO2/FiO2 Standard Deviation 0.64
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Treatment Day 12	2.2 Ratio SpO2/FiO2 Standard Deviation 0.93	2.9 Ratio SpO2/FiO2 Standard Deviation 0.72
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Treatment Day 13	2.2 Ratio SpO2/FiO2 Standard Deviation 0.71	2.8 Ratio SpO2/FiO2 Standard Deviation 0.71
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Treatment Day 14	2.2 Ratio SpO2/FiO2 Standard Deviation 0.77	3.0 Ratio SpO2/FiO2 Standard Deviation 0.73
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Time of Discharge Visit	3.1 Ratio SpO2/FiO2 Standard Deviation 0.36	3.2 Ratio SpO2/FiO2 Standard Deviation 0.42
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2) Follow up Day 28	3.2 Ratio SpO2/FiO2 Standard Deviation 0.44	3.0 Ratio SpO2/FiO2 Standard Deviation 0.85

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Length (in days) of the time of hospitalization until medical discharge

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Time to Discharge From the Hospital	10.8 days Standard Deviation 10.73	9.1 days Standard Deviation 9.09

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Proportion of patients who are hospitalized again after the discharge of first hospitalization.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Number of Patients With Re-hospitalization	6 Participants	7 Participants

SECONDARY outcome

Timeframe: First dose date up to Day 57

Population: The Intent-to-Treat (ITT) Analysis Set was used for the analysis and includes all randomized participants.

Proportion of participants admitted to hospital intensive care unit post randomization. The proportion of participants is represented as a percentage.

Outcome measures

Outcome measures
Measure	Asapiprant (BGE-175) n=96 Participants Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 Participants Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Proportion of Participants Requiring Intensive Care Unit Admission	22 Participants	17 Participants

Adverse Events

Asapiprant

Serious events: 34 serious events

Other events: 34 other events

Deaths: 16 deaths

Placebo

Serious events: 32 serious events

Other events: 32 other events

Deaths: 10 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Asapiprant n=96 participants at risk Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 participants at risk Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Metabolism and nutrition disorders Hypophosphataemia	5.2% 5/96 • Number of events 8 • From first dose of treatment through Study Day 57	3.1% 3/98 • Number of events 4 • From first dose of treatment through Study Day 57
Metabolism and nutrition disorders Hyperglycaemia	2.1% 2/96 • Number of events 2 • From first dose of treatment through Study Day 57	7.1% 7/98 • Number of events 7 • From first dose of treatment through Study Day 57
Metabolism and nutrition disorders Hypokalaemia	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	7.1% 7/98 • Number of events 8 • From first dose of treatment through Study Day 57
Gastrointestinal disorders Constipation	15.6% 15/96 • Number of events 15 • From first dose of treatment through Study Day 57	17.3% 17/98 • Number of events 20 • From first dose of treatment through Study Day 57
Gastrointestinal disorders Diarrhoea	5.2% 5/96 • Number of events 5 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Infections and infestations Urinary tract infection	5.2% 5/96 • Number of events 5 • From first dose of treatment through Study Day 57	3.1% 3/98 • Number of events 3 • From first dose of treatment through Study Day 57
Cardiac disorders Atrial fibrillation	5.2% 5/96 • Number of events 5 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
General disorders Pyrexia	5.2% 5/96 • Number of events 6 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
General disorders Non-cardiac chest pain	0.00% 0/96 • From first dose of treatment through Study Day 57	5.1% 5/98 • Number of events 5 • From first dose of treatment through Study Day 57

Additional Information

Patrick Martin, M.D.

BioAge Labs, Inc.

Phone: 215-260-5134

Email: [email protected]

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Measure	Asapiprant n=96 participants at risk Participants received two 50 mg tablets of asapiprant once daily for 14 days	Placebo n=98 participants at risk Participants received two 50 mg tablets of matching placebo tablet daily for 14 days
Respiratory, thoracic and mediastinal disorders Respiratory failure	22.9% 22/96 • Number of events 22 • From first dose of treatment through Study Day 57	21.4% 21/98 • Number of events 22 • From first dose of treatment through Study Day 57
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.1% 3/96 • Number of events 3 • From first dose of treatment through Study Day 57	4.1% 4/98 • Number of events 4 • From first dose of treatment through Study Day 57
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/96 • From first dose of treatment through Study Day 57	2.0% 2/98 • Number of events 2 • From first dose of treatment through Study Day 57
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Respiratory, thoracic and mediastinal disorders Pneumomediastinum	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Infections and infestations Septic shock	9.4% 9/96 • Number of events 9 • From first dose of treatment through Study Day 57	4.1% 4/98 • Number of events 4 • From first dose of treatment through Study Day 57
Infections and infestations Pulmonary sepsis	3.1% 3/96 • Number of events 4 • From first dose of treatment through Study Day 57	4.1% 4/98 • Number of events 5 • From first dose of treatment through Study Day 57
Infections and infestations Pneumonia bacterial	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	3.1% 3/98 • Number of events 3 • From first dose of treatment through Study Day 57
Infections and infestations Urosepsis	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 3 • From first dose of treatment through Study Day 57
Infections and infestations Bacterial sepsis	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/96 • From first dose of treatment through Study Day 57	2.0% 2/98 • Number of events 2 • From first dose of treatment through Study Day 57
Infections and infestations COVID-19	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Infections and infestations Pneumonia	2.1% 2/96 • Number of events 2 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Infections and infestations Sepsis	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Infections and infestations Bacterial infection	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Infections and infestations Cellulitis	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Infections and infestations Enterococcal sepsis	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Infections and infestations Fungaemia	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Infections and infestations Necrotising fasciitis	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Infections and infestations Severe acute respiratory syndrome	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Infections and infestations Staphylococcal abscess	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Infections and infestations Urinary tract infection	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Infections and infestations Urinary tract infection bacterial	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Cardiac disorders Acute myocardial infarction	2.1% 2/96 • Number of events 2 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Cardiac disorders Atrial fibrillation	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 2 • From first dose of treatment through Study Day 57
Cardiac disorders Supraventricular tachycardia	2.1% 2/96 • Number of events 2 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Cardiac disorders Cardiac arrest	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Cardiac disorders Cardiogenic shock	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Cardiac disorders Tachyarrhythmia	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Cardiac disorders Tachycardia	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Renal and urinary disorders Acute kidney injury	5.2% 5/96 • Number of events 5 • From first dose of treatment through Study Day 57	3.1% 3/98 • Number of events 3 • From first dose of treatment through Study Day 57
Renal and urinary disorders Renal impairment	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Vascular disorders Deep vein thrombosis	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Vascular disorders Hypotension	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Vascular disorders Hypovolaemic shock	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Vascular disorders Peripheral ischaemia	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Vascular disorders Shock	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Gastrointestinal disorders Diarrhoea	2.1% 2/96 • Number of events 2 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Gastrointestinal disorders Gastrointestinal haemorrhage	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Hepatobiliary disorders Acute hepatic failure	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Hepatobiliary disorders Hepatic failure	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Hepatobiliary disorders Hepatic function abnormal	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Investigations Cardiac output decreased	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Investigations Oxygen saturation decreased	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Metabolism and nutrition disorders Hypoglycaemia	1.0% 1/96 • Number of events 1 • From first dose of treatment through Study Day 57	0.00% 0/98 • From first dose of treatment through Study Day 57
Injury, poisoning and procedural complications Radius fracture	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57
Psychiatric disorders Delirium	0.00% 0/96 • From first dose of treatment through Study Day 57	1.0% 1/98 • Number of events 1 • From first dose of treatment through Study Day 57