Upstream Bio to Launch Phase 3 Verekitug Trials in Severe Asthma and CRSwNP with $341.5M Cash
Upstream Bio plans to initiate Phase 3 trials of verekitug in severe asthma and CRSwNP in Q1 2027, following Phase 2 data showing 56% reduction in asthma exacerbations at 100mg quarterly and 39% at 400mg biannual dosing. The company holds $341.5M cash, funding operations through 2027.
1. Phase 3 Development Strategy for Verekitug
Upstream Bio will advance verekitug into registrational studies targeting severe asthma and CRSwNP, prioritizing high-dose quarterly regimens up to 400 mg via single injection in broad patient populations without biomarker restriction. Engagement with regulators is planned later this year, with dosing initiation slated for Q1 2027.
2. Positive Phase 2 VALIANT Asthma Data
The Phase 2 VALIANT trial demonstrated a 56% reduction in annualized asthma exacerbations with 100 mg dosing every 12 weeks (p<0.0003) and a 39% reduction with 400 mg every 24 weeks (p<0.02), accompanied by significant lung function gains and a favorable safety profile across all cohorts.
3. Supportive CRSwNP Analyses from VIBRANT
Additional analyses from the Phase 2 VIBRANT trial showed consistent improvements in nasal congestion scores across high-exposure groups and pharmacokinetic modeling predicts that 400 mg quarterly achieves near-maximal suppression of exhaled nitric oxide, reinforcing verekitug’s potential in broad CRSwNP populations.
4. Solid Financial Position
Upstream Bio ended 2025 with $341.5 million in cash and investments, a balance expected to fully fund planned operations and the initiation of both Phase 3 programs through at least the end of 2027.