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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 studied for the treatment of pruritus, or itch. Its clinical trials have focused on cholestatic pruritus associated with primary biliary cholangitis or primary sclerosing cholangitis, as well as uremic pruritus. It is not approved for any indication and remains in clinical development.
EP547 targets MRGPRX4, a receptor in the mas-related G protein-coupled receptor family. By acting on this receptor, EP547 is designed to interfere with itch signaling. MRGPRX4 is a receptor target, and the drug is a small molecule.
EP547 is being developed by Incyte Corporation, which trades on the Nasdaq under the ticker INCY. Incyte is the sponsor of the clinical trials evaluating EP547 in pruritus.
EP547 is in Phase 2 clinical development. Two trials have been completed: a Phase 2 study in cholestatic pruritus and a Phase 1 study in healthy subjects and subjects with cholestatic or uremic pruritus. No active trials are currently listed.
EP547 has been evaluated in two completed trials. NCT05525520 was a Phase 2 study of EP547 in subjects with cholestatic pruritus due to primary biliary cholangitis or primary sclerosing cholangitis, enrolling 62 participants. NCT04510090 was a Phase 1 study of safety, tolerability, and pharmacokinetics in healthy subjects and subjects with cholestatic or uremic pruritus, enrolling 89 participants.