Corvus Pharmaceuticals‘ partner in China, Angel Pharma, has received approval from the China National Medical Products Administration (NMPA) to begin a Phase 1b/2 clinical trial of soquelitinib for moderate-to-severe atopic dermatitis. Angel Pharma, co-founded by Corvus and holding the license for soquelitinib’s development and commercialization in greater China, will fully fund the trial. This trial will explore a longer treatment duration and a higher dose than previously tested.
This approval is particularly important because atopic dermatitis is prevalent in China, with increasing use of biologics and systemic therapies. Positive results from this trial could position soquelitinib as a significant treatment option in a large and growing market, boosting Corvus’s overall investment in the drug and strengthening Angel Pharma’s position in the Chinese pharmaceutical market. This expansion into China also allows for a wider range of patient data and potentially accelerates the global development timeline for soquelitinib.
The Phase 1b trial is a randomized, double-blinded, placebo-controlled study, testing soquelitinib at various doses (100mg twice daily, 200mg once and twice daily, and 400mg once daily) over a 12-week period. A subsequent Phase 2 trial will further investigate two selected doses based on the Phase 1b results. Corvus is concurrently running a Phase 1 extension cohort and plans to initiate a Phase 2 trial in the U.S. by the end of 2025.
This Chinese trial signifies an important step forward for soquelitinib’s development. The data generated will be crucial for understanding the drug’s efficacy and safety profile in a broader patient population, influencing future clinical development strategies in both China and globally. The success of this trial could lead to a new treatment option for atopic dermatitis patients and potentially open doors for soquelitinib in other indications.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
