Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EP547 · 2 trials · 3 indications
Participants were asked to rate the severity of their worst level of itching in the past 24 hours using the daily WI-NRS, an 11-point scale ranging from 0 (no itching) to 10 (worst itching imaginable). Itching severity scores collected via the WI-NRS have been categorized in the as mild (\<4), moderate (≥4 to \<7), or severe (≥7). The average WI-NRS score using the daily values from the week before the first dose of study drug (including the WI-NRS score captured on Study Day 1 of dosing) served as the Baseline score. A weekly score was determined based on the average of all available daily scores of the week. Change from Baseline was calculated as the post-Baseline score minus the Baseline score.
To assess safety and tolerability of EP547 following single and multiple oral administration
| Arm | Type | Description |
|---|---|---|
| EP547 100 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| EP547 Single Dose | EXPERIMENTAL | Single doses of EP547 |
| EP547 Multiple Doses | EXPERIMENTAL | Multiple doses of EP547 |
| Placebo Single Dose | PLACEBO_COMPARATOR | Single doses of placebo |
| Placebo Multiple Doses | PLACEBO_COMPARATOR | Multiple doses of placebo |
| Name | Type | Description |
|---|---|---|
| EP547 | DRUG | Once daily |
| Placebo | DRUG | Once daily |
Inclusion Criteria: * Age 18 to 80 years * Documented primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC) * Presence of consistent moderate to severe pruritus * Use of anti-pruritic and anti-cholestatic (including UDCA and obeticholic acid) medication allowed if meeting additi...
EP547 is an investigational small molecule being developed for pruritus, or itching. It is being studied in cholestatic pruritus due to primary biliary cholangitis or primary sclerosing cholangitis, as well as in uremic pruritus associated with kidney failure. It is not yet approved and remains in clinical development.
EP547 is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker INCY. Incyte is conducting clinical trials to evaluate the safety, tolerability, and efficacy of EP547 in patients with pruritus.
EP547 is in Phase 2 clinical development. It has completed a Phase 1 trial in healthy subjects and subjects with cholestatic or uremic pruritus, and a Phase 2 trial in subjects with cholestatic pruritus due to primary biliary cholangitis or primary sclerosing cholangitis. It is not FDA approved.
EP547 has been studied in two completed clinical trials. NCT04510090 was a Phase 1 trial in healthy subjects and subjects with cholestatic or uremic pruritus. NCT05525520 was a Phase 2 trial in subjects with cholestatic pruritus due to primary biliary cholangitis or primary sclerosing cholangitis.
EP547 is a small molecule, but its specific molecular target has not been disclosed. It is being studied for its effects on pruritus in conditions such as cholestatic pruritus and uremic pruritus, with the goal of reducing itch in these patient populations.