GlobeNewswire·Sep 1, 2026, 7:00 AM ET

Upstream Bio Announces Pivotal Phase 3 Development Plans for Verekitug in Both Severe Asthma and CRSwNP

Upstream Bio will study 400 mg of verekitug administered every 12 weeks versus placebo in severe asthma & chronic rhinosinusitis with nasal polyps (CRSwNP) following productive FDA discussions.
The company plans to conduct one pivotal Phase 3 trial in each indication with broad patient populations irrespective of biomarker status.
Phase 3 trials are expected to enroll approximately 1,500 patients total & initiate in Q1 2027.
Primary endpoints include annualized asthma exacerbation rates (AAER) over 48 weeks for severe asthma & changes in nasal polyp score & nasal congestion score at 48 weeks for CRSwNP.
Verekitug is the only known TSLP receptor antagonist in clinical development & has treated over 500 participants in prior programs.
With supportive Phase 3 results, the company expects to submit a Biologics License Application (BLA) to the FDA & potentially launch as early as 2030.
Verekitug is also currently being evaluated in an ongoing Phase 2 trial for chronic obstructive pulmonary disease (COPD).