Nearly 58 patients with moderate-to-severe pruritus will take part in the trial. Credit: Chokniti Khongchum from Pixabay.

Escient Pharmaceuticals has commenced a Phase II clinical trial of selective MRGPRX4 antagonist EP547 in cholestatic pruritus subjects.

The Phase II randomised, double-blind, placebo-controlled PACIFIC study has been designed for evaluating EP547’s safety, efficacy, and tolerability in subjects with cholestatic pruritus due to primary biliary cholangitis (PBC) or primary sclerosing cholangitis (PSC).

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Nearly 58 patients with moderate-to-severe pruritus due to PBC or PSC will take part in the trial, which consists of a six-week double-blind treatment period.

Subjects in this period are randomised in a 1:1 ratio to receive 100mg EP547 or a placebo, dosed orally once a day, followed by an open label extension period for six weeks.

During this period, all subjects will receive EP547.

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Variation from baseline to week six in itch intensity is the study’s primary efficacy endpoint.

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Escient Pharmaceuticals president and chief medical officer Christian Weyer said: “Building upon the excellent safety, tolerability, and PK profile of EP547 in our previously completed Phase I study, we are excited to initiate the Phase II PACIFIC study, designed to establish definitive clinical proof-of-concept of MRGPRX4 antagonism in cholestatic pruritus.

“While the initial focus of our clinical programme is focused on PBC and PSC, we believe EP547 has broad potential as a targeted anti-pruritic treatment for other forms of intra- and extrahepatic cholestasis.”

MRGPRX4 is a cell surface receptor that is expressed on sensory neurons activated by bile acids, bilirubin, and other heme metabolites.

It is expected to serve as a key mediator of the intense itch often experienced by patients with cholestatic liver disease.