Verekitug Cuts Asthma Exacerbations Up to 56%, Improves FEV1 by 122 mL
Upstream Bio’s Phase II VALIANT trial showed verekitug 100mg every 12 weeks cut annualized asthma exacerbations by 56% and improved FEV1 by 122 mL; the 400mg every 24 weeks dose cut exacerbations by 39%. Anti-drug antibodies emerged in 50–60% of subjects without safety impact, and Phase III programs are planned.
1. VALIANT Trial Design and Efficacy
The Phase II VALIANT study enrolled 478 adults with severe asthma across four arms: verekitug 100 mg every 12 weeks (121 patients), 400 mg every 24 weeks (118), 100 mg every 24 weeks (120), and placebo (119). The trial met its primary endpoint, showing annualized asthma exacerbation rate reductions of 56% for 100 mg Q12W, 39% for 400 mg Q24W, and 49% for 100 mg Q24W versus placebo, alongside FEV1 gains of 122 mL and 139 mL for the two highest regimens and FeNO reductions of ~43–45% from baseline maintained through 60 weeks.
2. Safety and Immunogenicity
Verekitug was generally well tolerated, with similar overall treatment-emergent adverse event rates across all groups and no deaths reported. Bronchitis incidence was higher at the two highest doses, while anti-drug antibodies appeared in 50–60% of participants but did not correlate with safety issues or diminished efficacy.
3. Next Steps
Upstream Bio plans an integrated analysis combining VALIANT and Phase II CRSwNP data to refine dose selection, then initiate parallel Phase III trials in severe asthma and chronic rhinosinusitis with nasal polyps. The company is also advancing device formats, including prefilled syringes and an autoinjector, and continues enrollment in a Phase II COPD study.