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Angel Pharmaceuticals Announces IND Approval for Phase 1b/2 Clinical Trial of Soquelitinib in Atopic Dermatitis in China
Jiaxing, June 25, 2025 – Angel Pharmaceuticals today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved its application to initiate a Phase 1b/2 clinical trial of soquelitinib (CPI-818) in patients with atopic dermatitis (AD) in China. Soquelitinib is a clinical-stage, highly selective, oral small-molecule inhibitor of ITK (interleukin-2-inducible T-cell kinase).
Professor Shi Yuling, the lead investigator of this trial, Vice President of Shanghai Dermatology Hospital, Tenured Distinguished Professor at Tongji University School of Medicine, and Executive Committee Member of the International Psoriasis Council (IPC), commented: "Compared with current injectable biologic therapies that can only inhibit single or limited cytokines, soquelitinib, as an oral drug, can block multiple cytokines involved in the inflammatory process and is expected to significantly improve the current treatment landscape for atopic dermatitis. The latest U.S. clinical trial data show that ITK inhibition therapy with soquelitinib will provide a safer, more effective, and more convenient new treatment option for atopic dermatitis patients. We are very much looking forward to the clinical development of this drug in China to further explore its clinical potential."
Dr. Richard A. Miller, MD, Co-founder and Chairman of Angel Pharmaceuticals, said: "This is an important milestone for Angel Pharmaceuticals and fully demonstrates the determination of the Angel team to bring first-in-class novel immunotherapies that significantly improve quality of life to Chinese patients."
About the Phase 1b/2 Clinical Trial of Soquelitinib in Atopic Dermatitis in China
Angel Pharmaceuticals' Phase 1b/2 clinical trial of soquelitinib in AD patients will build on the preliminary results from Corvus Pharmaceuticals (hereinafter "Corvus"), investigating longer treatment durations and additional dose options. If supported by the results of the Phase 1b trial, it can efficiently transition to the Phase 2 trial. The Phase 1b trial will adopt a randomized, double-blind, placebo-controlled design and enroll patients with moderate-to-severe atopic dermatitis (AD) as follows:
Soquelitinib Cohort 1 (24 subjects total) – 8 patients receiving placebo; 8 patients receiving soquelitinib 100 mg twice daily; 8 patients receiving soquelitinib 200 mg once daily.
Soquelitinib Cohort 2 (24 subjects total) – 8 patients receiving placebo; 8 patients receiving soquelitinib 200 mg twice daily; 8 patients receiving soquelitinib 400 mg once daily.
The treatment period is 12 weeks.
The Phase 2 trial will also be a randomized, double-blind, placebo-controlled study. It will enroll a larger number of patients and select two doses based on the safety and efficacy results from the Phase 1b trial.
Angel Pharmaceuticals holds the rights to soquelitinib in Greater China. The company is developing soquelitinib for multiple indications, including this approved Phase 1b/2 clinical trial for patients with moderate-to-severe AD.
As of May 28, 2025, Angel Pharmaceuticals' strategic partner Corvus had enrolled 48 patients with moderate-to-severe AD (36 receiving soquelitinib, 12 receiving placebo) in a Phase 1 clinical trial in the United States, all of whom had completed a 28-day treatment course. Overall, the trial data demonstrated favorable safety and efficacy, with soquelitinib-treated patients showing a significant improvement in Eczema Area and Severity Index (EASI) scores at Day 28 compared to placebo (p=0.036). Soquelitinib was well tolerated, with no dose-limiting toxicities and no clinically meaningful laboratory abnormalities observed. Compared to Groups 1 and 2 (100 mg BID, 200 mg QD, total daily dose 200 mg), Group 3 of the trial (soquelitinib 200 mg BID, total daily dose 400 mg) showed earlier and deeper responses, with 50% of patients (6/12) in Group 3 achieving EASI 75 at Day 28, compared to 0% (0/12) in the placebo group.
About Atopic Dermatitis
Atopic dermatitis, also known as eczema, is a chronic disease that causes skin inflammation, redness, scaling, blistering, and irritation. Current treatment options include topical therapies, oral medications, and systemic injectable biologic agents. Atopic dermatitis is frequently associated with other allergic conditions such as food allergies and asthma. Like asthma and allergies, atopic dermatitis involves Th2 lymphocytes, whose secreted cytokines drive inflammation. Preclinical studies have shown that soquelitinib inhibits cytokine production by Th2 lymphocytes. China has over 65 million AD patients, of whom nearly 28% have moderate-to-severe disease. The market size is expected to exceed $4 billion by 2030.
About Soquelitinib
Soquelitinib (CPI-818) is a clinical-stage, highly selective, oral small-molecule ITK inhibitor. ITK is primarily expressed in T cells and plays a role in the immune function of T cells and natural killer (NK) cells. Studies have shown that soquelitinib can influence T-cell differentiation, induce the production of Th1 helper cells, while blocking the development of Th2 and Th17 cells and their cytokine production. Th1 cells are essential for immunity against tumors, viral infections, and other infectious diseases. Th2 and Th17 helper T cells are involved in the pathogenesis of many autoimmune and allergic diseases. The company believes that inhibiting this specific molecular target in T cells may have therapeutic benefits for patients with cancers, including solid tumors, as well as those with autoimmune and allergic diseases. Recent studies have shown that ITK controls the switch between Th17 cells (pro-inflammatory) and regulatory T cells (anti-inflammatory). Inhibiting ITK promotes T-cell differentiation toward regulatory T cells, potentially suppressing autoimmune and inflammatory responses. In December 2024, a recent paper detailing the chemistry, enzymology, and biology of soquelitinib was published in npj Drug Discovery.
About Angel Pharmaceuticals
Angel Pharmaceuticals is a biopharmaceutical company focused on innovative therapies for immune modulation, committed to developing breakthrough drugs to improve the treatment of cancer, autoimmune diseases, and inflammatory disorders by targeting key signaling pathways in T and B cells. The company is co-invested by Beta Fund, Hisun Pharmaceuticals, Tigermed, and Puhua Investment, and has established a strategic partnership with Corvus Pharmaceuticals (CRVS) of the U.S. For more information, please visit www.angelpharma.com.
