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: ...
Top 8 of 10 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | ibuzatrelvir, Nirmatrelvir/ ritonavir, BNT162b2/RIV |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE3 | BNT162b2 |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Molnupiravir |
| Invivyd, Inc. | IVVD | 2 | PHASE3 | VYD2311 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE3 | Tradipitant |
| ImmunityBio Inc | IBRX | 2 | PHASE2 | Nogapendekin alfa inbakicept |
| Traws Pharma, Inc. | TRAW | 1 | PHASE2 | Ratutrelvir |
| GeoVax Labs, Inc. | GOVX | 1 | PHASE2 | GEO-CM04S1 |
EDP-235 is an investigational antiviral being developed for the treatment of COVID-19 and SARS-CoV-2 infection. It is a small molecule oral drug candidate studied in non-hospitalized adults with COVID-19. Enanta Pharmaceuticals is developing it as a direct-acting antiviral for respiratory viral infections.
EDP-235 targets the SARS-CoV-2 3CL protease, a viral enzyme essential for coronavirus replication. By inhibiting this protease, the drug aims to block processing of viral polyproteins needed for the virus to multiply. The 3CL protease is a well-characterized antiviral target in coronavirus drug development.
EDP-235 is being developed by Enanta Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ENTA. Enanta is a clinical-stage biotechnology company focused on small molecule drugs for viral infections and immune disorders, and EDP-235 is its oral antiviral candidate for COVID-19.
EDP-235 has completed Phase 2 clinical development. Its lead study was a Phase 2 trial in non-hospitalized adults with COVID-19, and supporting Phase 1 studies have also been completed. The drug is investigational and has not been approved by the FDA for any indication.
EDP-235 has been studied in four completed trials: NCT05616728, a Phase 2 study in non-hospitalized adults with COVID-19; NCT05246878, a Phase 1 study in healthy subjects; and two Phase 1 drug-drug interaction studies, NCT05594615 and NCT05594602, in healthy volunteers. Total enrollment across these studies was 291 participants.
No, EDP-235 is not FDA approved. It remains an investigational drug that has completed Phase 2 testing in COVID-19. Any potential regulatory submission would depend on further clinical development, and no approval has been granted for the treatment of COVID-19 or SARS-CoV-2 infection.