Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as EDP-305 Dose 1
EDP 305 · 8 trials · 5 indications
Blood samples were collected at specific timepoints for the laboratory evaluation to assess the ALT level. Baseline refers to the average of the screening and the Day 1 values; if either the screening or Day 1 values were missing, the non-missing value was used. Mean change was defined as the mean value at Week 12 minus the mean value at baseline.
Percent change was calculated as \[(ALP at Week 12 - ALP at Baseline)/ALP at Baseline\] \*100. The participant was considered to have successfully achieved a 20% reduction in ALP if the result was ≤-20. The participant was considered to have successfully achieved ALP normalization if ALP was abnormal at Baseline and normal at Week 12.
| Arm | Type | Description |
|---|---|---|
| EDP-305 Dose 1 | EXPERIMENTAL | Subjects will take 2 tablets once a day orally for 12 weeks |
| EDP-305 Dose 2 | EXPERIMENTAL | Subjects will take 2 tablets once a day orally for 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Subjects will take 2 tablets once a day orally for 12 weeks |
| EDP-305 1 mg | EXPERIMENTAL | Subjects will take 2 tablets once a day orally for 12 weeks |
| EDP-305 2.5 mg | EXPERIMENTAL | Subjects will take 2 tablets once a day orally for 12 weeks |
| EDP-305 and Oral Contraceptive | EXPERIMENTAL | - |
| Single arm EDP-305 | EXPERIMENTAL | - |
| EDP-305 and fluconazole interaction (Part 1) | EXPERIMENTAL | - |
| EDP-305 and quinidine interaction (Part 2) | EXPERIMENTAL | - |
| Mild hepatic impairment group | EXPERIMENTAL | - |
| Moderate hepatic impairment group | EXPERIMENTAL | - |
| Matching healthy control group | EXPERIMENTAL | Healthy control group will be matched with the hepatically impaired population with respect to age, sex and BMI |
| Single Arm | EXPERIMENTAL | - |
| EDP 305 SAD Cohorts | EXPERIMENTAL | EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration |
| EDP 305 MAD Cohorts | EXPERIMENTAL | EDP 305 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral suspension, once daily for 14 days |
| EDP 305 SAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral suspension, once daily in one single administration |
| EDP 305 MAD Placebo Cohort | PLACEBO_COMPARATOR | Matching placebo, oral suspension, once daily for 14 days |
| Name | Type | Description |
|---|---|---|
| EDP-305 Dose 1 | DRUG | Two tablets daily for 12 weeks |
| EDP-305 Dose 2 | DRUG | Two tablets daily for 12 weeks |
| Placebo | DRUG | Two tablets daily for 12 weeks |
| EDP-305 1 mg | DRUG | Two tablets daily for 12 weeks |
| EDP-305 2.5 mg | DRUG | Two tablets daily for 12 weeks |
| EDP-305 | DRUG | Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3 |
| Oral Contraceptive | DRUG | Subjects will receive active Oral Contraceptive on Days 1-21 and inert OC on Days 22-28 of cycles 1, 2 and 3 |
| Fluconazole | DRUG | Subjects will receive fluconazole once daily from Day 5 to Day 18 |
| Quinidine | DRUG | Subjects will receive quinidine twice daily from Day 5 to Day 12 |
| EDP 305 | DRUG | Each subject will receive a single dose of EDP 305 on Day 1. |
| Midazolam | DRUG | Each subject will receive midazolam on Days 1 and 12. |
| Caffeine | DRUG | Each subject will receive caffeine on Days 1 and 12. |
| Rosuvastatin | DRUG | Each subject will receive rosuvastatin on Days 2 and 13. |
Inclusion Criteria: * An informed consent document must be signed and dated by the subject * Male and female subjects of any ethnic origin between the ages of 18 and 75 years, inclusive * Male or female with presence of NASH by: * Histologic evidence on a historical liver biopsy within 24 months...
EDP 305 is an investigational small molecule developed by Enanta Pharmaceuticals for metabolic liver diseases. It has been studied in nonalcoholic steatohepatitis (NASH), presumptive NAFLD, and primary biliary cholangitis. It is not approved and remains in clinical development.
EDP 305 has been studied as a treatment for nonalcoholic steatohepatitis, a fatty liver disease with inflammation and liver cell injury. Clinical trials enrolled patients with NASH, and a Phase 2 study evaluated safety, tolerability, pharmacokinetics, and efficacy in subjects with the condition.
EDP 305 targets FXR, the farnesoid X receptor, a nuclear receptor that regulates bile acid and metabolic pathways. FXR is the molecular target of EDP 305, and the drug is a small molecule designed to act on this receptor.
EDP 305 is developed by Enanta Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ENTA. Enanta is the sponsor of the clinical program studying EDP 305 in NASH and related liver conditions.
EDP 305 is in Phase 1 development overall, with completed Phase 1 trials and a completed Phase 2 study in nonalcoholic steatohepatitis. It is investigational and has not been approved by the FDA. No trials are currently active.
EDP 305 has been studied in completed trials including NCT03421431, a Phase 2 study in nonalcoholic steatohepatitis, and Phase 1 trials NCT03783897, NCT03748628, and NCT03610945. These Phase 1 studies examined drug interactions and absorption, metabolism, and excretion in healthy volunteers.
Yes, EDP 305 is the same as EDP-305. The alternative names EDP-305 Dose 1 and EDP-305 1 mg refer to the same investigational compound developed by Enanta Pharmaceuticals for NASH and related liver diseases.