Upstream Bio Posts 56% AAER Drop in Phase 2 Verekitug Trial, Plans Phase 3
Upstream Bio’s Phase 2 VALIANT trial in 478 severe asthma patients cut annualized exacerbations by 56% at 100 mg q12w and 39% at 400 mg q24w versus placebo. Week-60 outcomes showed 122–139 mL FEV1 gains, 20–26 ppb FeNO suppression, and over 90% of patients rolled into the long-term extension ahead of planned Phase 3 trials.
1. Trial Design and Primary Endpoint
VALIANT was a global, randomized, double-blind, placebo-controlled Phase 2 trial enrolling 478 adults with severe asthma to assess verekitug’s safety and efficacy over up to 60 weeks, using dosing regimens of 100 mg every 12 weeks and 400 mg every 24 weeks.
2. Efficacy Results
The study met its primary endpoint with a 56% reduction in annualized asthma exacerbation rate at 100 mg q12w (p<0.0003) and 39% at 400 mg q24w (p<0.02), alongside week 60 forced expiratory volume (FEV1) gains of 122 mL and 139 mL, and exhaled nitric oxide reductions of 20.4 ppb and 26.3 ppb, respectively.
3. Safety and Extension Study
Verekitug was generally well tolerated, with a safety profile consistent with previous data. More than 90% of eligible patients transitioned into the VALOUR long-term extension study to evaluate durability of response and long-term safety.
4. Next Steps and Pipeline Advancement
Upstream Bio intends to initiate Phase 3 trials in severe asthma and chronic rhinosinusitis with nasal polyps following planned regulatory interactions, while concurrently advancing a Phase 2 COPD study that has enrolled over 60% of its target population.