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=99 Participants	47.8 years STANDARD_DEVIATION 14.14 • n=107 Participants	47.4 years STANDARD_DEVIATION 14.28 • n=206 Participants
Sex: Female, Male Female	25 Participants n=99 Participants	26 Participants n=107 Participants	51 Participants n=206 Participants
Sex: Female, Male Male	15 Participants n=99 Participants	15 Participants n=107 Participants	30 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=99 Participants	7 Participants n=107 Participants	16 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=99 Participants	34 Participants n=107 Participants	65 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants	3 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) White	35 Participants n=99 Participants	36 Participants n=107 Participants	71 Participants n=206 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 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 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
Number of Subjects With RSV RNA Viral Load Below Limit of Detection (LOD) Day 14	26 Participants	23 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.