Angel Pharmaceuticals Ltd. has received regulatory approval from China's National Medical Products Administration (NMPA) to initiate a Phase 1b/2 clinical trial of soquelitinib for treating patients with moderate-to-severe atopic dermatitis. The approval from the Center for Drug Evaluation (CDE) marks a significant milestone for the investigational ITK inhibitor developed by partner company Corvus Pharmaceuticals.
Trial Design and Patient Enrollment
The Phase 1b portion will be a randomized, double-blinded, placebo-controlled study enrolling 48 patients with moderate-to-severe atopic dermatitis across two cohorts. Cohort 1 will include 24 patients randomized to receive placebo, soquelitinib 100 mg twice daily, or soquelitinib 200 mg once daily. Cohort 2 will similarly enroll 24 patients receiving placebo, soquelitinib 200 mg twice daily, or soquelitinib 400 mg once daily.
The trial will feature a 12-week treatment period, extending beyond previous studies to provide additional safety and efficacy data. Angel Pharma anticipates beginning patient enrollment in the third quarter of 2025, with Phase 1b data expected to be available in 2026.
The Phase 2 portion will also follow a randomized, double-blinded, placebo-controlled design, enrolling additional patients and focusing on two doses selected based on safety and efficacy results from the Phase 1b trial.
Clinical Leadership and Expertise
Dr. Yuling Shi will serve as principal investigator for the Phase 1b/2 clinical trial. Dr. Shi is a professor of dermatology and Vice President of Shanghai Skin Disease Hospital at Tongji University School of Medicine. She founded and directs the Institute of Psoriasis at Tongji University School of Medicine, recognized as China's first psoriasis institute, and has published more than 100 peer-reviewed articles focusing on psoriasis, skin autoimmunity, and inflammatory skin diseases.
Therapeutic Approach and Market Context
Soquelitinib represents an investigational oral, small molecule drug that selectively inhibits ITK (interleukin-2-inducible T-cell kinase). Corvus Pharmaceuticals is pioneering ITK inhibition as a novel approach to immunotherapy for cancer and immune diseases.
"Atopic dermatitis affects patients worldwide, including a significant number in China where treatment with biologics and other systemic therapies is growing in use," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "Based on our clinical data to-date, we believe soquelitinib could be a compelling new treatment option for atopic dermatitis in China and globally."
Partnership Structure and Development Strategy
Angel Pharmaceuticals was co-founded by Corvus to develop its pipeline in greater China. The company licensed rights from Corvus to develop, manufacture and commercialize soquelitinib in greater China and assumes responsibility for all development expenses in the region. Corvus maintains approximately 49.7% ownership interest in Angel, excluding equity reserved for employee stock ownership.
Angel Pharmaceuticals operates as a privately held biopharmaceutical company developing immune modulators for cancer, autoimmune, infectious and other serious diseases in China. The company was launched through strategic collaboration with Corvus and investments from Zhejiang Puissance Capital, Hisun Pharmaceuticals, Tigermed and funds associated with Betta Pharmaceuticals.
Parallel U.S. Development Program
While Angel Pharma advances the China program, Corvus continues development in the United States with ongoing patient enrollment in its Phase 1 extension cohort. The company plans to initiate a Phase 2 trial by the end of 2025.
Miller noted that the Angel Phase 1b/2 trial will expand clinical experience with soquelitinib in atopic dermatitis, particularly through the extended 12-week treatment period and evaluation of a 400 mg once-daily dose regimen.
