Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP-938 · 9 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.
| Arm | Type | Description |
|---|---|---|
| EDP-938 | EXPERIMENTAL | EDP-938 800 mg, once daily |
| Placebo | PLACEBO_COMPARATOR | Matching placebo, once daily |
| 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 |
| 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...
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EDP-938 is an investigational small molecule being developed for the treatment of respiratory syncytial virus (RSV) infection. It is currently in Phase 2 clinical development and has not been approved by the FDA.
EDP-938 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ENTA.
EDP-938 is in Phase 2 clinical development for the treatment of respiratory syncytial virus (RSV) infection. It is an investigational drug and has not received regulatory approval.
EDP-938 has been studied in six clinical trials, all of which are completed. These include Phase 1 studies in healthy volunteers, such as NCT03384823, NCT03750383, NCT03755778, and NCT04498741, which evaluated drug-drug interactions and safety.
No alternative names for EDP-938 have been disclosed. It is referred to solely as EDP-938 in clinical trial records and by its developer, Enanta Pharmaceuticals.