Upstream Bio plans pivotal Phase 3 programs for verekitug in severe asthma and CRSwNP, with approximately 1,500 patients enrolled across the studies. For investors, the plan sets a first-quarter 2027 trial start and, if results are supportive, a potential FDA application that could enable launch as early as 2030.

Key Highlights

  • Verekitug’s planned Phase 3 design uses a high-dose subcutaneous regimen.
  • Patient populations will be broad, without restrictions based on baseline biomarkers.
  • Supportive results could lead to a Biologics License Application and potential launch as early as 2030.

Verekitug Trials Set Broad Enrollment

The proposed dosing design centers on a high-dose subcutaneous regimen for verekitug. A placebo-controlled study is planned in severe asthma, with another in CRSwNP, and combined enrollment is expected to reach approximately 1,500 patients. The populations are intended to be broad, with no restriction based on baseline biomarkers. Asthma’s primary endpoint is annualized exacerbation rates, while CRSwNP uses co-primary measures covering changes from baseline in nasal polyp score and nasal congestion score.

Potential FDA Application Could Support 2030 Launch

Upstream Bio (NASDAQ: UPB) remains on track to begin the Phase 3 trials in the first quarter of 2027.

Peers Moving on This News

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