Corvus Says Partner Angel Pharma's IND Approved By CDE Of China NMPA To Initiate Phase 1b/2 Clinical Trial Of Soquelitinib For Treatment Atopic Dermatitis In China

Author: Benzinga Newsdesk | June 25, 2025 07:10am

Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company, today announced that the IND application submitted by its partner in China, Angel Pharmaceuticals Ltd. (Angel Pharma), has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) to initiate a Phase 1b/2 clinical trial of soquelitinib for the treatment of patients with moderate-to-severe atopic dermatitis in China.

Corvus co-founded Angel Pharma to develop its pipeline in greater China. Angel Pharma licensed the rights from Corvus to develop, manufacture and commercialize soquelitinib in greater China and is responsible for all expenses related to its development in China.

Angel Pharma's Phase 1b/2 clinical trial for soquelitinib in patients with atopic dermatitis will build on the data previously presented by Corvus from its ongoing Phase 1 trial by studying a longer treatment period and an additional dosing option. The Phase 1b trial will be randomized, double-blinded, placebo-controlled and enroll patients with moderate-to-severe atopic dermatitis as follows:

• Soquelitinib Cohort 1 (24 patients) – 8 patients receive placebo, 8 patients receive soquelitinib 100 mg twice per day and 8 patients receive soquelitinib 200 mg once per day
• Soquelitinib Cohort 2 (24 patients) – 8 patients receive placebo, 8 patients receive soquelitinib 200 mg twice per day and 8 patients receive soquelitinib 400 mg once per day
• The treatment period will be 12 weeks

The Phase 2 trial will also be a randomized, double-blinded, placebo-controlled study. It will enroll additional patients and focus on two doses that will be selected based on the safety and efficacy results from the Phase 1b trial.

The principal investigator of the Phase 1b/2 clinical trial is Yuling Shi, M.D, Ph.D. Dr. Shi is professor of dermatology, the Vice President of Shanghai Skin Disease Hospital at the Tongji University School of Medicine, and the founder and director of the Institute of Psoriasis at Tongji University School of Medicine, the first psoriasis institute in China. Dr. Shi has published more than 100 peer-reviewed articles, most focusing on psoriasis, skin autoimmunity, and inflammatory skin diseases.

Posted In: CRVS