Upstream Bio (UPB) announced its pivotal Phase 3 development plans for its drug candidate, verekitug, for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP), following discussions with the FDA.
Key Details
- Trial Initiation: Phase 3 clinical trials are on track to begin in the first quarter of 2027.
- Study Design: The company will conduct two separate placebo-controlled studies, one for each indication, enrolling a total of approximately 1,500 patients. The trials will evaluate a single 400mg subcutaneous dose administered every 12 weeks.
- Regulatory Timeline: Following supportive Phase 3 results, Upstream Bio expects to submit a Biologics License Application (BLA) to the FDA, with a potential market launch as early as 2030.