Astria Therapeutics has launched a Phase 1a clinical trial for STAR-0310, a monoclonal antibody designed to treat atopic dermatitis (AD). The trial will evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of STAR-0310 in healthy adults. Astria anticipates preliminary results in Q3 2025.
This trial initiation is a critical step in validating STAR-0310’s potential as a best-in-class AD treatment. Success in this phase would provide crucial safety and pharmacokinetic data, laying the foundation for larger trials in patients with AD. This progress could attract further investment and partnerships, accelerating development. A successful outcome could address the significant unmet need for safer and more effective AD therapies, potentially offering relief to a large patient population.
The Phase 1a trial is a randomized, double-blind, placebo-controlled study of approximately 40 healthy adult participants. Preclinical data suggests STAR-0310 has a longer half-life than typical antibodies and comparable potency to rocatinlimab, a competing OX40 antagonist. Importantly, STAR-0310 demonstrates significantly less antibody-dependent cellular cytotoxicity (ADCC) compared to rocatinlimab, potentially leading to a safer treatment profile.
Positive results from this Phase 1a trial will pave the way for further clinical development of STAR-0310. This could position Astria as a leader in AD therapeutics and potentially expand the use of STAR-0310 to other immunological diseases. The results will be a key inflection point, informing future development strategies and potentially reshaping the treatment landscape for AD.
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.