Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as EDP-938 Dose 1, zelicapavir (therapeutic dose), zelicapavir (supratherapeutic dose)
EDP-938 · 10 trials · 3 indications
Resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm\[sputum\]) as assessed by RiiQTM Scale Score is zero or 1. Time to resolution of LRTD symptoms is calculated as: date/time of resolution - date/time of first dose with conversion to days.
Complete resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm\[sputum\]) as assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Scale Score is zero. Time to complete resolution of LRTD symptoms is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.
Complete resolution of LRTD Symptoms is defined as the first of two consecutive timepoints where each of the four LRTD symptoms (cough, short of breath, wheezing and coughing up phlegm\[sputum\]) as assessed by RiiQTM Scale Score is zero. Time to complete resolution of LRTD symptoms is calculated as: date/time of complete resolution - date/time of first dose with conversion to days.
Plasma concentrations of EDP-938 were assessed at the designated time points.
TEAEs were defined as any event, side effect, or untoward medical occurrence in a participant enrolled in a clinical study whether or not it was considered to have a causal relationship to the study drug and first occurred or worsened during the post-baseline phase compared to baseline. Clinically significant changes from baseline in vital signs and clinical laboratory results were reported as TEAEs.
Daily change from baseline in RSV shedding was defined as the daily change from baseline in RSV ribonucleic acid (RNA) viral load and was measured using reverse transcription-quantitative polymerase chain reaction (RT-qPCR) from nasal swabs. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by Day interaction term as factors. An unstructured covariance matrix was imposed. The Satterthwaite approximation is used to estimate the denominator degrees of freedom.
Daily change from baseline in RSV shedding was defined as the daily change from baseline in RSV RNA viral load and was measured using RT-qPCR from nasal swabs. The model included treatment group (EDP-938, placebo) and Day (3, 5, 9, and 14) as fixed effect, associated baseline, and treatment group by Day interaction term as factors. An unstructured covariance matrix was imposed.The Satterthwaite approximation is used to estimate the denominator degrees of freedom.
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.
Measured in nasal washes by quantitative reverse transcription polymerase chain reaction (RT-qPCR) in participants inoculated with respiratory syncytial virus-A (RSV-A) Memphis 37b.
| Arm | Type | Description |
|---|---|---|
| EDP-938 | EXPERIMENTAL | EDP-938 800 mg, once daily |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, once daily |
| EDP-938 Arm A | EXPERIMENTAL | Subjects will take EDP-938 Dose 1 oral suspension for 5 days |
| EDP-938 Arm B | EXPERIMENTAL | Subjects will take EDP-938 Dose 2 oral suspension for 5 days |
| Placebo Arm C | PLACEBO_COMPARATOR | Subjects will take matching placebo oral suspension for 5 days |
| EDP-938 Arm D | EXPERIMENTAL | Subjects will take EDP-938 Dose 3 oral suspension for 5 days |
| EDP-938 Arm E | EXPERIMENTAL | Subjects will take EDP-938 Dose 4 oral suspension for 5 days |
| Placebo Arm F | PLACEBO_COMPARATOR | Subjects will take matching placebo oral suspension for 5 days |
| Single arm EDP-938 | EXPERIMENTAL | - |
| EDP-938 and Fluconazole interaction | EXPERIMENTAL | - |
| EDP-938 and tacrolimus interaction (Part 1) | EXPERIMENTAL | - |
| EDP-938 and dabigatran interaction (Part 2) | EXPERIMENTAL | - |
| EDP-938 and rosuvastatin interaction (Part 3) | EXPERIMENTAL | - |
| EDP-938 and midazolam interaction (Part 4) | EXPERIMENTAL | - |
| EDP-938 and itraconazole interaction (Part 1) | EXPERIMENTAL | - |
| EDP-938 and rifampin interaction (Part 2) | EXPERIMENTAL | - |
| EDP-938 and quinidine interaction (Part 3) | EXPERIMENTAL | - |
| EDP-938 and cyclosporine interaction (Part 1) | EXPERIMENTAL | - |
| EDP-938 and prednisone interaction (Part 2) | EXPERIMENTAL | - |
| EDP-938 SAD Cohorts | EXPERIMENTAL | EDP-938 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration |
| EDP-938 MAD Cohorts | EXPERIMENTAL | EDP-938 Dose 1, Dose 2, Dose 3, and Dose 4 oral suspension, once daily for 7 days |
| EDP-938 SAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral suspension, once daily in one single administration |
| EDP-938 MAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral suspension, once daily for 7 days |
| Name | Type | Description |
|---|---|---|
| EDP-938 | DRUG | Subjects took EDP-938 once daily for 5 days |
| Placebo | DRUG | Subjects took matching placebo, once daily for 5 days |
| EDP-938 Dose 1 | DRUG | Oral suspension for 5 days |
| EDP-938 Dose 2 | DRUG | Oral suspension for 5 days |
| EDP-938 Dose 3 | DRUG | Oral suspension for 5 days |
| EDP-938 Dose 4 | DRUG | Oral suspension for 5 days |
| Fluconazole | DRUG | Subjects will receive fluconazole once daily on Days 5 to 18 |
| Tacrolimus | DRUG | Subjects will receive tacrolimus once daily on Day 1 and Day 24 |
| Dabigatran | DRUG | Subjects will receive dabigatran once daily on Day 1 and Day 13 |
| Rosuvastatin | DRUG | Subjects will receive rosuvastatin once daily on Day 1 and Day 13 |
| Midazolam | DRUG | Subjects will receive midazolam once daily on Day 1 and Day 16 |
| Itraconazole | DRUG | Subjects will receive itraconazole once daily from Day 5 to Day 18 |
| Rifampin | DRUG | Subjects will receive rifampin once daily from Day 5 to Day 16 |
| Quinidine | DRUG | Subjects will receive quinidine once daily from Day 5 to Day 12 |
| Cyclosporine | DRUG | Subjects will receive one dose of cyclosporine on Day 5 |
| Prednisone | DRUG | Subjects will receive prednisone once daily from Day 5 to Day 14 |
Inclusion Criteria: * At least one of the following conditions that predispose them to complications after RSV infection: 1. Age ≥65 years 2. Congestive heart failure (CHF) 3. Asthma 4. Chronic obstructive pulmonary disease (COPD) * The subject has a new onset of any of the following sympt...
Top 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
EDP-938 is an investigational antiviral being developed for the treatment of respiratory syncytial virus, or RSV, infection. It is being studied in adults at high risk for RSV complications and in children with RSV. It is a small molecule and has not been approved for any indication.
EDP-938 targets the RSV N-protein, a viral nucleoprotein involved in viral replication. By binding this protein target, the small molecule is designed to interfere with the virus rather than act on a human host target. It is an investigational agent in clinical development.
EDP-938 is being developed by Enanta Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ENTA. The company is the sponsor of the clinical program studying the drug in respiratory syncytial virus infection across adult and pediatric populations.
EDP-938 is in Phase 2 clinical development. Seven trials have been completed, including Phase 1 and Phase 2 studies, and no trials are currently active. The drug remains investigational and has not been approved by the FDA for any indication.
Completed EDP-938 trials include NCT05568706, a Phase 2 study in non-hospitalized adults with RSV at high risk for complications, and NCT04816721, a Phase 2 study of EDP-938 regimens in children with RSV. Earlier Phase 1 work included NCT04927793 and NCT04871724.
Yes, EDP-938 Dose 1 refers to the same investigational compound as EDP-938. The alternate name reflects a dosing arm used in the clinical program rather than a separate drug. Both names point to the RSV antiviral developed by Enanta Pharmaceuticals.