Kymera Therapeutics has initiated its BroADen Phase 1b clinical trial for KT-621, an oral STAT6 degrader, in patients with moderate to severe atopic dermatitis (AD). Data from this trial, as well as from a completed Phase 1 healthy volunteer trial, are expected in the fourth quarter of 2025 and June 2025, respectively. The company plans to launch two parallel Phase 2b trials in AD and asthma in late 2025 and early 2026.
This development marks a significant advancement in AD treatment. KT-621 is the first STAT6-targeted agent in clinical development. If successful, it offers the potential for a convenient, orally administered alternative to current injectable biologics, expanding treatment access for a wider patient population. This is crucial given the significant unmet need for effective AD therapies, particularly for those with moderate to severe forms of the disease. The potential for an oral medication with comparable efficacy to biologics could significantly improve patient adherence and quality of life, addressing the burden of chronic itch and skin inflammation.
The BroADen trial will evaluate KT-621’s safety, tolerability, and effectiveness in approximately 20 adult patients. Researchers will analyze its impact on STAT6 degradation in blood and skin, Th2 biomarkers, and clinical endpoints like EASI and pruritus NRS scores. The subsequent Phase 2b trials aim to expedite KT-621’s development and inform dose selection for future Phase 3 registration studies across various Th2-driven conditions, including dermatological, gastrointestinal, and respiratory indications. This indicates a broad potential application of KT-621 beyond AD, targeting a large patient population suffering from diverse Th2-mediated diseases.
The progress of KT-621 suggests a possible shift in the treatment landscape for AD and other related diseases. Positive results from these trials could lead to a new class of oral therapeutics, offering a more accessible and convenient alternative to existing treatments. This could represent a significant step forward in managing these chronic conditions and improving the lives of millions of patients worldwide.
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.
