Trial Outcomes & Findings for A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects (NCT NCT04196101)

NCT ID: NCT04196101

Last Updated: 2023-10-30

Results Overview

Assessed by the RSV Symptom Diary, including 13 items assessing the severity of RSV-related signs and symptoms. The diary uses a 4-point scale that consists of grading symptoms on a scale of 0 to 3 for each item, where Grade 0 is Absent, Grade 1 is Noticeable, Grade 2 is Bothersome but not preventing activity, and Grade 3 is Bothersome and interfering with activities. TSS is derived daily by summing of the 13 observed symptom grade values from Day 1 through Day 14 to generate the curve for analysis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

82 participants

Primary outcome timeframe

Day 1 through Day 14

Results posted on

2023-10-30

Participant Flow

Participant milestones

Participant milestones
Measure	EDP-938 Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days EDP-938: Four tablets daily for 5 days	Placebo Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days Placebo: Four tablets daily for 5 days
Overall Study STARTED	41	41
Overall Study COMPLETED	31	30
Overall Study NOT COMPLETED	10	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EDP-938 n=40 Participants Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days EDP-938: Four tablets daily for 5 days	Placebo n=41 Participants Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days Placebo: Four tablets daily for 5 days	Total n=81 Participants Total of all reporting groups
Age, Continuous	47.0 years STANDARD_DEVIATION 14.61 • n=5 Participants	47.8 years STANDARD_DEVIATION 14.14 • n=7 Participants	47.4 years STANDARD_DEVIATION 14.28 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	34 Participants n=7 Participants	65 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 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	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	36 Participants n=7 Participants	71 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 through Day 14

Population: The mITT population included 66 subjects, comprised of all randomized subjects positively diagnosed using the central RT-PCR test who received at least one dose of the assigned study drug or placebo. Per SAP, one subject in the EDP-938 group with only baseline data was excluded from analysis.

Outcome measures

Outcome measures
Measure	EDP-938 n=33 Participants Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days EDP-938: Four tablets daily for 5 days	Placebo n=33 Participants Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days Placebo: Four tablets daily for 5 days
Total Symptom Score (TSS) Area Under the Curve (AUC) RSV A	93.64 days x Score Standard Deviation 97.180	62.53 days x Score Standard Deviation 40.310
Total Symptom Score (TSS) Area Under the Curve (AUC) RSV B	73.75 days x Score Standard Deviation 66.652	78.34 days x Score Standard Deviation 58.051

SECONDARY outcome

Timeframe: Day 1 through Day 14

Population: The mITT population included 66 subjects, comprised of all randomized subjects positively diagnosed using the central RT-PCR test who received at least one dose of the assigned study drug or placebo. Per SAP, one subject in the placebo group and two subjects in the EDP-938 group with only baseline data were excluded from analysis.

RSV RNA viral load as measured in nasopharyngeal swab samples by RT-qPCR on Days 1 (Baseline, time 0), 3, 5, 9, and 14 to generate curve for analysis.

Outcome measures

Outcome measures
Measure	EDP-938 n=31 Participants Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days EDP-938: Four tablets daily for 5 days	Placebo n=32 Participants Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days Placebo: Four tablets daily for 5 days
RSV RNA Viral Load Area Under the Curve (AUC)	37.00 days x log10 copies/mL Standard Deviation 24.003	46.96 days x log10 copies/mL Standard Deviation 21.002

SECONDARY outcome

Timeframe: Days 3, 5, 9 and 14

Population: Based on subjects positively diagnosed using the central RT-PCR test and with detectable viral load at baseline and non-missing viral load assessment at the respective visit and is used as a denominator in the percentage calculation.

Proportion of patients that have undetectable RSV RNA by qRT-PCR at Days 3, 5, 9 and 14.

Outcome measures

Outcome measures
Measure	EDP-938 n=33 Participants Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days EDP-938: Four tablets daily for 5 days	Placebo n=33 Participants Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days Placebo: Four tablets daily for 5 days
Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD) Day 14	26 Participants	23 Participants
Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD) Day 3	5 Participants	2 Participants
Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD) Day 5	12 Participants	5 Participants
Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD) Day 9	15 Participants	11 Participants

SECONDARY outcome

Timeframe: Day 1 through Day 14

Outcome measures

Outcome measures
Measure	EDP-938 n=40 Participants Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days EDP-938: Four tablets daily for 5 days	Placebo n=41 Participants Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days Placebo: Four tablets daily for 5 days
Number of Participants With Adverse Events	11 Participants	11 Participants

Adverse Events

EDP-938

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Guy De La Rosa, MD Senior Director, Infectious Diseases

Enanta Pharmaceuticals, Inc

Phone: (617) 607-0800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	EDP-938 n=40 participants at risk Subjects will take EDP-938 tablets (800 mg) once a day orally for 5 days EDP-938: Four tablets daily for 5 days	Placebo n=41 participants at risk Subjects will take EDP-938 matching placebo tablets once a day orally for 5 days Placebo: Four tablets daily for 5 days
Infections and infestations Conjunctivitis	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Infections and infestations Influenza	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Infections and infestations Laryngitis	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Infections and infestations Oral herpes	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	4.9% 2/41 • Number of events 2 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Infections and infestations Oropharyngeal candidiasis	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Infections and infestations Urinary tract infection	5.0% 2/40 • Number of events 2 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	4.9% 2/41 • Number of events 2 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Investigations Alanine aminotransferase increased	2.5% 1/40 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Investigations Aspartate aminotransferase increased	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Investigations Blood chloride decreased	2.5% 1/40 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	0.00% 0/41 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Investigations Blood cholesterol increased	2.5% 1/40 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	0.00% 0/41 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Investigations Blood creatine phosphokinase increased	2.5% 1/40 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	0.00% 0/41 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Investigations Blood sodium decreased	2.5% 1/40 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	0.00% 0/41 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Investigations Crystal urine present	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Investigations Protein total decreased	2.5% 1/40 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	0.00% 0/41 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Investigations Urine ketone body present	2.5% 1/40 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	0.00% 0/41 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Nervous system disorders Dizziness	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Nervous system disorders Headache	2.5% 1/40 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	9.8% 4/41 • Number of events 4 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Nervous system disorders Syncope	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Gastrointestinal disorders Diarrhoea	5.0% 2/40 • Number of events 2 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	0.00% 0/41 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Gastrointestinal disorders Dyspepsia	2.5% 1/40 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	0.00% 0/41 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Respiratory, thoracic and mediastinal disorders Haemoptysis	2.5% 1/40 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	0.00% 0/41 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Blood and lymphatic system disorders Anaemia	2.5% 1/40 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	0.00% 0/41 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Blood and lymphatic system disorders Leukocytosis	2.5% 1/40 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	0.00% 0/41 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
General disorders Chills	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
General disorders Pyrexia	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Hepatobiliary disorders Hepatic cirrhosis	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Hepatobiliary disorders Hepatic function abnormal	2.5% 1/40 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	0.00% 0/41 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Cardiac disorders Tachycardia	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Metabolism and nutrition disorders Dehydration	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/40 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.	2.4% 1/41 • Number of events 1 • Participants were assessed over a period of two weeks; five days of dosing and nine days of follow-up.