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Upstream Bio on Track to Begin Two Phase 3 Verekitug Trials in Q1 2027

Upstream Bio on Track to Begin Two Phase 3 Verekitug Trials in Q1 2027

MT newswireMT newswire2026/09/01 11:31
07:31 AM EDT, 09/01/2026 (MT Newswires) -- Upstream Bio (UPB) is on track to initiate Phase 3 clinical trials of verekitug in severe asthma and chronic rhinosinusitis with nasal polyps, or CRSwNP, in the first quarter of 2027, the company said Tuesday. Following its discussions with the US Food and Drug Administration, Upstream Bio decided to evaluate a 400-milligram subcutaneous dose of verekitug in both indications, administered every 12 weeks and compared with placebo, according to the statement. The two placebo-controlled trials are expected to enroll about 1,500 patients combined and will not restrict enrollment based on baseline biomarkers. The primary endpoint of the Phase 3 trial in severe asthma is annualized asthma exacerbation rates over 48 weeks, while co-primary endpoints for CRSwNP are the change from baseline in nasal polyp score and nasal congestion score, each at 48 weeks, the company said. With supportive Phase 3 results, Upstream Bio expects to submit biologics license applications, or BLAs, to the FDA for both indications, potentially enabling a launch as early as 2030, the company added.
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