Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EDP-305 Dose 1 · 1 trial · 1 indication
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.
| 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 |
| 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 |
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 Dose 1 is an investigational small molecule being studied for the treatment of Non-Alcoholic Steatohepatitis (NASH) and RSV Infection. It is being developed by Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA). The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
EDP-305 Dose 1 is a small molecule being developed for Non-Alcoholic Steatohepatitis and RSV Infection. The specific molecular target has not been disclosed in available information. The drug is currently in Phase 2 clinical trials to evaluate its safety, tolerability, pharmacokinetics, and efficacy.
EDP-305 Dose 1 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 potential in treating Non-Alcoholic Steatohepatitis and RSV Infection.
EDP-305 Dose 1 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for Non-Alcoholic Steatohepatitis and RSV Infection, with completed Phase 2 trials in both indications.
EDP-305 Dose 1 has been studied in two completed Phase 2 clinical trials. NCT03421431 assessed the drug in 134 subjects with Non-Alcoholic Steatohepatitis across multiple countries. NCT03691623 evaluated EDP-938, a related compound, in 179 healthy volunteers using an RSV challenge model in the United Kingdom.
EDP-305 Dose 1 and EDP-938 are distinct investigational compounds developed by Enanta Pharmaceuticals. EDP-305 Dose 1 is being studied for Non-Alcoholic Steatohepatitis, while EDP-938 was evaluated in an RSV challenge model. Both are small molecules in Phase 2 development, but they are not the same drug.