$UPB (UPSTREAM BIO) — 8-K: Upstream Bio plans Phase 3 trials of verekitug 400mg every 12 weeks in severe asthma and CRSwNP, starting Q1 2027

Upstream Bio will run one placebo-controlled Phase 3 trial each in severe asthma and chronic rhinosinusitis with nasal polyps, enrolling approximately 1,500 patients total across both trials. The studies will evaluate a single high-dose subcutaneous regimen of 400mg verekitug administered every 12 weeks. Severe asthma will measure annualized asthma exacerbation rates over 48 weeks; CRSwNP will use co-primary endpoints of change from baseline in nasal polyp score and nasal congestion score at 48 weeks. With supportive Phase 3 results, the company expects to submit a Biologics License Application for both indications, potentially enabling launch as early as 2030.

Upstream Bio will run one placebo-controlled Phase 3 trial each in severe asthma and chronic rhinosinusitis with nasal polyps, enrolling approximately 1,500 patients total across both trials. The studies will evaluate a single high-dose subcutaneous regimen of 400mg verekitug administered every 12 weeks. Severe asthma will measure annualized asthma exacerbation rates over 48 weeks; CRSwNP will use co-primary endpoints of change from baseline in nasal polyp score and nasal congestion score at 48 weeks. With supportive Phase 3 results, the company expects to submit a Biologics License Application for both indications, potentially enabling launch as early as 2030.