Trial Outcomes & Findings for Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections (NCT NCT02469857)

Last Updated: 2021-10-05

Results Overview

NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure (i.e., a "responder"): (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14. This analysis compared responders in the reltecimod group versus responders in the placebo group. Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

290 participants

Primary outcome timeframe

28 days

Results posted on

2021-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Reltecimod (AB103) 0.5 mg/kg Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo NaCl 0.9%, single IV infusion over approximately 10 minutes
Overall Study STARTED	143	147
Overall Study COMPLETED	118	115
Overall Study NOT COMPLETED	25	32

Reasons for withdrawal

Reasons for withdrawal
Measure	Reltecimod (AB103) 0.5 mg/kg Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo NaCl 0.9%, single IV infusion over approximately 10 minutes
Overall Study Death	24	29
Overall Study Discontinuation	1	3

Baseline Characteristics

Phase III Efficacy and Safety Study of AB103 in the Treatment of Patients With Necrotizing Soft Tissue Infections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reltecimod (AB103) 0.5 mg/kg n=143 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=147 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes	Total n=290 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 15.3 • n=5 Participants	56.3 years STANDARD_DEVIATION 15.0 • n=7 Participants	54.9 years STANDARD_DEVIATION 15.2 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants	59 Participants n=7 Participants	117 Participants n=5 Participants
Sex: Female, Male Male	85 Participants n=5 Participants	88 Participants n=7 Participants	173 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	131 Participants n=5 Participants	133 Participants n=7 Participants	264 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Race (NIH/OMB) White	106 Participants n=5 Participants	110 Participants n=7 Participants	216 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	135 participants n=5 Participants	138 participants n=7 Participants	273 participants n=5 Participants
Region of Enrollment France	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants
Body Mass Index (BMI)	31.4 kg/m^2 STANDARD_DEVIATION 8.3 • n=5 Participants	33.7 kg/m^2 STANDARD_DEVIATION 8.3 • n=7 Participants	32.5 kg/m^2 STANDARD_DEVIATION 8.4 • n=5 Participants
Necrotizing Soft Tissue Infection (NSTI) Diagnosis Necrotizing Fasciitis	96 Participants n=5 Participants	95 Participants n=7 Participants	191 Participants n=5 Participants
Necrotizing Soft Tissue Infection (NSTI) Diagnosis Fournier's Gangrene	43 Participants n=5 Participants	40 Participants n=7 Participants	83 Participants n=5 Participants
Necrotizing Soft Tissue Infection (NSTI) Diagnosis Gas Gangrene/Myonecrosis	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Necrotizing Soft Tissue Infection (NSTI) Diagnosis Other NSTI	3 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants
Comorbidities Diabetes	64 Participants n=5 Participants	59 Participants n=7 Participants	123 Participants n=5 Participants
Comorbidities Cardiovascular Disease	37 Participants n=5 Participants	28 Participants n=7 Participants	65 Participants n=5 Participants
Comorbidities Smoker	34 Participants n=5 Participants	32 Participants n=7 Participants	66 Participants n=5 Participants
Comorbidities Alcohol Abuse	17 Participants n=5 Participants	13 Participants n=7 Participants	30 Participants n=5 Participants
Modified Sequential Organ Failure Assessment (mSOFA) Score	5.6 score on a scale STANDARD_DEVIATION 2.5 • n=5 Participants	5.4 score on a scale STANDARD_DEVIATION 2.2 • n=7 Participants	5.5 score on a scale STANDARD_DEVIATION 2.4 • n=5 Participants
Acute Physiology And Chronic Health Evaluation II (APACHE II) Score	16.4 score on a scale STANDARD_DEVIATION 6.8 • n=5 Participants	16.4 score on a scale STANDARD_DEVIATION 6.6 • n=7 Participants	16.4 score on a scale STANDARD_DEVIATION 6.7 • n=5 Participants
Sepsis Presentation Cardiovascular Organ Failure	81 Participants n=5 Participants	62 Participants n=7 Participants	143 Participants n=5 Participants
Sepsis Presentation Respiratory Organ Failure	19 Participants n=5 Participants	11 Participants n=7 Participants	30 Participants n=5 Participants
Acute Kidney Injury (AKI) Presentation Any AKI at Screening	87 Participants n=5 Participants	103 Participants n=7 Participants	190 Participants n=5 Participants
Acute Kidney Injury (AKI) Presentation Stage 2 or 3 AKI at Screening	62 Participants n=5 Participants	81 Participants n=7 Participants	143 Participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Population: The primary analysis population (modified intent-to-treat \[mITT\]) included all randomized patients who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. A secondary analysis of the primary outcome measure utilized the United States-modified intent-to-treat (US-mITT) analysis population which consisted only of mITT patients enrolled in the United States.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=142 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=148 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE) mITT Population	69 Participants	59 Participants
Number of Patients Achieving Necrotizing Infections Clinical Composite Endpoint (NICCE) US-mITT Population	67 Participants	50 Participants

SECONDARY outcome

Timeframe: 28 days

Population: As Treated/Safety Analysis Population: all randomized patients who were exposed to study drug (active or placebo) and categorized according to the treatment actually received.

Number of Patients With One or More Adverse Events (AEs). Serious Adverse Events (SAEs) are included in this outcome measure since SAEs are a subset of AEs.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=143 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=147 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Patients With One or More Adverse Events (AEs)	104 Participants	96 Participants

SECONDARY outcome

Timeframe: 28 days

Population: As Treated/Safety Analysis Population: all randomized patients who were exposed to study drug (active or placebo) and categorized according to the treatment actually received.

Number of Patients with One or More Serious Adverse Events (SAEs) During the Study

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=143 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=147 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Patients With One or More Serious Adverse Events (SAEs)	44 Participants	40 Participants

SECONDARY outcome

Timeframe: 28 days

Population: As Treated/Safety Analysis Population: all randomized patients who were exposed to study drug (active or placebo) and categorized according to the treatment actually received.

Number of Patients with One or More Secondary Infections During the Study

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=143 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=147 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Patients With One or More Secondary Infections	30 Participants	32 Participants

SECONDARY outcome

Timeframe: 14 days

Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=135 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=138 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Patients Achieving Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1	87 Participants	74 Participants

SECONDARY outcome

Timeframe: 28 days

ICU-free days refers to the number of days a patient did not spend time in the ICU through Day 28.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=135 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=138 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Intensive Care Unit (ICU)-Free Days	20.0 days Interval 0.0 to 28.0	18.0 days Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: 28 days

Ventilator-free days refers to the number of days a patient was not on a ventilator through Day 28.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=135 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=138 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Ventilator-free Days	22.0 days Interval 0.0 to 28.0	21.0 days Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: 28 days

Vasopressor-free days refers to the number of days a patient did not receive a vasopressor through Day 28.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=135 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=138 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Vasopressor-free Days	25.0 days Interval 0.0 to 28.0	25.0 days Interval 0.0 to 28.0

SECONDARY outcome

Timeframe: 90 days or until end of follow up

Hospital days refers to the number of days a patient spent time in the hospital.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=135 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=138 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Hospital Days	18.0 days Interval 1.0 to 103.0	19.5 days Interval 2.0 to 135.0

SECONDARY outcome

Timeframe: 90 days

Number of patients with more favorable discharge location (home or rehabilitation facility) or less favorable discharge location (skilled nursing facility, another acute care facility, death, other)

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=135 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=138 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Patients With a More Favorable or Less Favorable Hospital Discharge Location More Favorable Discharge Location	80 Participants	64 Participants
Number of Patients With a More Favorable or Less Favorable Hospital Discharge Location Less Favorable Discharge Location	55 Participants	74 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

The number of deaths occurring from Study Day 0 through Study Day 90

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=135 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=138 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Deaths From Day 0 Through Day 90	24 Participants	29 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 76 days (after Day 14 through Day 90)

Population: The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population alive on Day 14 (119 reltecimod patients and 124 placebo patients) were included in this analysis.

Number of deaths after Study Day 14 through Study Day 90

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=119 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=124 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Deaths After Day 14 Through Day 90	8 Participants	15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Population: The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with a Screening mSOFA score of at least 5 were included in this analysis.

Number and percentage of patients with a Screening mSOFA score of at least 5 who were alive on Study Day 0 and subsequently died through Study Day 90.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=77 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=79 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Deaths From Day 0 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5	16 Participants	19 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 76 days (after Day 14 through Day 90)

Population: The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with a Screening mSOFA score of at least 5 who were alive on Day 14 (64 reltecimod patients and 69 placebo patients) were included in this analysis.

Number and percentage of patients with a Screening mSOFA score of at least 5 who were alive on Study Day 14 and subsequently died through Study Day 90.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=64 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=69 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Deaths After Day 14 Through Day 90 Among Patients With a Screening mSOFA Score of at Least 5	3 Participants	9 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 90 days

Population: The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with baseline cardiovascular failure (i.e., shock; 75 reltecimod patients and 56 placebo patients) were included in this analysis.

Number and percentage of patients with baseline cardiovascular failure (shock) who died through Study Day 90.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=75 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=56 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Deaths From Day 0 Through Day 90 Among Patients With Baseline Cardiovascular Failure (Shock)	14 Participants	15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 76 days (after Day 14 through Day 90)

Population: The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with baseline cardiovascular failure (i.e., shock; 63 reltecimod patients and 48 placebo patients) were included in this analysis.

Number and percentage of patients with baseline cardiovascular failure (shock) who were alive on Study Day 14 and subsequently died through Study Day 90.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=63 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=48 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Deaths After Day 14 Through Day 90 Among Patients With Baseline Cardiovascular Failure (Shock)	2 Participants	7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Population: The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with a Screening mSOFA score of at least 5 (77 reltecimod patients and 79 placebo patients) were included in this analysis.

NICCE was made up of the following 5 components, all of which had to be met to successfully achieve the primary outcome measure: (i) Alive at Day 28, (ii) ≤ 3 debridements through Day 14, (iii) No amputation performed after the first debridement, (iv) Day 14 modified Sequential Organ Failure Assessment (mSOFA) score ≤ 1, and (v) Reduction of ≥ 3 mSOFA score points between Baseline and Day 14. Modified Sequential Organ Failure Assessment (mSOFA) total scores range from 0 to 20, with higher scores reflecting a worse clinical status or outcome. An mSOFA total score of 0 or 1 reflects resolution of organ dysfunction/failure.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=77 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=79 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Patients With a Screening Modified Sequential Organ Failure Assessment (mSOFA) Score of at Least 5 Who Achieved NICCE	38 Participants	25 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 days

Population: The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with a Screening mSOFA score of at least 5 (77 reltecimod patients and 79 placebo patients) were included in this analysis.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=77 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=79 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Patients With a Screening mSOFA Score of at Least 5 Who Achieved Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1	45 Participants	29 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 28 days

Population: The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with baseline cardiovascular failure (i.e., shock; 75 reltecimod patients and 56 placebo patients) were included in this analysis.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=75 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=56 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved NICCE	38 Participants	18 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 14 days

Population: The United States modified intent-to-treat (US-mITT) population included all randomized patients in the United States who were exposed to study drug and who had a definitive diagnosis of NSTI based on surgical verification. This population does not include 17 patients randomized in France. Data from patients in the US-mITT population with baseline cardiovascular failure (i.e., shock; 75 reltecimod patients and 56 placebo patients) were included in this analysis.

Outcome measures

Outcome measures
Measure	Reltecimod (AB103) 0.5 mg/kg n=75 Participants Reltecimod 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=56 Participants NaCl 0.9%, single IV infusion over approximately 10 minutes
Number of Patients With Baseline Cardiovascular Failure (Shock) Who Achieved Day 14 Modified Sequential Organ Failure Assessment (mSOFA) Score of 0 or 1	48 Participants	21 Participants

Adverse Events

Reltecimod (AB103) 0.5 mg/kg

Serious events: 44 serious events

Other events: 24 other events

Deaths: 24 deaths

Placebo

Serious events: 40 serious events

Other events: 25 other events

Deaths: 29 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Reltecimod (AB103) 0.5 mg/kg n=143 participants at risk Reltecimod (AB103) 0.5 mg/kg, single IV infusion over approximately 10 minutes	Placebo n=147 participants at risk NaCl 0.9%, single IV infusion over approximately 10 minutes
Blood and lymphatic system disorders Anemia	5.6% 8/143 • Number of events 10 • Adverse event (AE) data were collected from study drug administration through the Day 28 visit. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit. Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit.	4.1% 6/147 • Number of events 7 • Adverse event (AE) data were collected from study drug administration through the Day 28 visit. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit. Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit.
Cardiac disorders Atrial fibrillation	4.9% 7/143 • Number of events 7 • Adverse event (AE) data were collected from study drug administration through the Day 28 visit. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit. Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit.	5.4% 8/147 • Number of events 8 • Adverse event (AE) data were collected from study drug administration through the Day 28 visit. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit. Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit.
Gastrointestinal disorders Diarrhea	4.2% 6/143 • Number of events 6 • Adverse event (AE) data were collected from study drug administration through the Day 28 visit. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit. Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit.	5.4% 8/147 • Number of events 8 • Adverse event (AE) data were collected from study drug administration through the Day 28 visit. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit. Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit.
Infections and infestations Pneumonia	3.5% 5/143 • Number of events 5 • Adverse event (AE) data were collected from study drug administration through the Day 28 visit. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit. Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit.	7.5% 11/147 • Number of events 11 • Adverse event (AE) data were collected from study drug administration through the Day 28 visit. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit. Safety data obtained during study visits associated with Study Days 1, 2, 3, 7, 10, 14, 21, and 28 were systematically assessed throughout the study. In addition, data from spontaneously reported AEs were included in safety assessments. Data associated with deaths and study drug-related serious adverse events (SAEs) were collected from study drug administration though the Day 90 visit.

Additional Information

Wayne M Dankner, MD, Chief Medical Officer

Atox Bio, Ltd.

Phone: 1-919-219-6377

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place