Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP-235 · 4 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| EDP-235 200mg | EXPERIMENTAL | Once a day orally for 5 days |
| EDP-235 400mg | EXPERIMENTAL | Once a day orally for 5 days |
| Placebo | PLACEBO_COMPARATOR | Once a day orally for 5 days |
| EDP-235 and Itraconazole interaction (Part 1) | EXPERIMENTAL | Subjects will receive EDP-235 and Itraconazole on respective dosing days |
| EDP-235 and Carbamazepine interaction (Part 2) | EXPERIMENTAL | Subjects will receive EDP-235 and Carbamazepine on respective dosing days |
| EDP and Quinidine interaction (Part 3) | EXPERIMENTAL | Subjects will receive EDP-235 and Quinidine on respective dosing days |
| EDP-235, midazolam, rosuvastatin and caffeine | EXPERIMENTAL | Subjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days |
| EDP-235 SAD Cohorts | EXPERIMENTAL | EDP-235 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5, orally, once daily in one single administration |
| EDP-235 MAD Cohorts | EXPERIMENTAL | EDP-235 Dose 1, Dose 2 and Dose 3 orally, once daily for 7 days |
| EDP-235 SAD Placebo Cohorts | PLACEBO_COMPARATOR | Matching placebo, orally, once daily in one single administration |
| EDP-235 MAD Placebo Cohorts | PLACEBO_COMPARATOR | Matching placebo, orally, once daily for 7 days |
| Name | Type | Description |
|---|---|---|
| EDP-235 | DRUG | capsule |
| Placebo | DRUG | capsule |
| Itraconazole | DRUG | Subjects will receive itraconazole QD Days 5-18 |
| Carbamazepine | DRUG | Subjects will receive carbamazepine BID Days 5-23 and Days 24-27 |
| Quinidine | DRUG | Subjects will receive quinidine BID Days 5-12 |
| Midazolam | DRUG | Subjects will receive midazolam once daily on Days 1 and 12 |
| Rosuvastatin | DRUG | Subjects will receive rosuvastatin once daily on Days 2 and 13 |
| Caffeine | DRUG | Subjects will receive caffeine once daily on Days 1 and 12 |
Inclusion Criteria: * SARS-CoV-2 infection confirmed by positive test ≤24 hours before randomization * COVID-19 symptom onset within 5 days prior to randomization and at least 2 signs/symptoms attributable to COVID-19 present and one of at least moderate severity at Screening Exclusion Criteria: ...
EDP-235 is an investigational small molecule being developed for the treatment of SARS-CoV-2 infection and COVID-19. It is being studied in non-hospitalized adults with COVID-19, as well as in healthy subjects for safety and drug interaction studies.
EDP-235 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ENTA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating COVID-19.
EDP-235 is in Phase 2 clinical development for the treatment of COVID-19. It has completed Phase 1 studies in healthy subjects and a Phase 2 study in non-hospitalized adults with COVID-19. The drug is investigational and has not been approved by regulatory authorities.
EDP-235 has been studied in four clinical trials. Phase 1 trials include NCT05246878 in healthy subjects, NCT05594602 studying interactions with itraconazole, carbamazepine and quinidine, and NCT05594615 studying interactions with midazolam, caffeine and rosuvastatin. The Phase 2 trial, NCT05616728, evaluated EDP-235 in non-hospitalized adults with COVID-19.
No, EDP-235 is not FDA approved. It is an investigational drug currently in clinical development. All completed trials, including Phase 1 and Phase 2 studies, have been finished, but the drug has not received regulatory approval for the treatment of COVID-19.
EDP-235 is a small molecule antiviral drug. While its specific molecular target has not been disclosed, it is being developed to treat SARS-CoV-2 infection and COVID-19. The drug is designed to interfere with viral replication, but the exact mechanism has not been publicly detailed.