Hengrui JAK1 inhibitor phase II clinical trial for alopecia areata reached the primary endpoint

Article source: Medical Rubik's Cube Info

Author: Sunshine

On August 24, Hengrui announced that the Phase II clinical study RSJ10521 (CRYSTAL2) of the SHR0302 tablet for the treatment of alopecia areata developed by its subsidiary Ruishi Biotechnology has reached the primary study endpoint

The results showed that patients who received oral monotherapy of SHR0302 tablets of 8 mg or 4 mg once a day had significantly higher percentages of changes from baseline in the score of the baldness severity score tool (hereinafter referred to as "SALT") than the placebo group

Alopecia areata is an autoimmune disease, which is non-scarring hair loss caused by the body's own cells attacking hair follicles

SHR0302 is a highly selective JAK1 inhibitor that can exert anti-inflammatory and immune-suppressing biological effects by inhibiting JAK1 signal transduction

The RSJ10521 study is a randomized, double-blind, placebo-controlled, multi-center phase II clinical study to evaluate the effectiveness and safety of oral SHR0302 tablets versus placebo in the treatment of moderate to severe alopecia areata.

A total of 94 subjects were enrolled in the study.

On January 4, 2018, Hengrui and Arcutis of the United States reached a US$223 million cooperation on SHR0302

Previously, Hengrui's 2021 semi-annual report listed in detail the clinical research and development pipeline of SHR0302

At present, JAK1 inhibitors have been approved for marketing or are undergoing clinical development for different indications at home and abroad, but no oral JAK1 inhibitors for the treatment of alopecia areata have been approved for marketing

Up to now, the accumulated research and development expenses of SHR0302 related projects are about 331.