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Upstream Bio announced pivotal Phase 3 development plans for verekitug in severe asthma and chronic rhinosinusitis…
UPBUpstream Bio, Inc.
Upstream Bio announced pivotal Phase 3 development plans for verekitug in severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) following FDA discussions. The company will conduct separate placebo-controlled trials enrolling approximately 1,500 patients total, evaluating a single high-dose subcutaneous regimen of 400mg administered every 12 weeks. Primary endpoints include annualized asthma exacerbation rates for asthma and changes in nasal polyp and congestion scores for CRSwNP over 48 weeks. Phase 3 trials are scheduled to initiate in the first quarter of 2027, with potential Biologics License Application submission and launch as early as 2030 if results are supportive. Upstream Bio is a clinical-stage biotechnology company developing treatments for severe inflammatory respiratory diseases.