VALIANT Phase 2 Findings on Verekitug

Upstream Bio reported positive top-line Phase 2 results for verekitug in adults with severe asthma.

The VALIANT trial, a global, randomized, double-blind, placebo-controlled, dose-ranging, parallel-group study, met its primary endpoint based on annualized asthma exacerbation rate (AAER). VALIANT enrolled 478 patients with severe asthma and evaluated verekitug for up to 60 weeks, with a minimum of 24 weeks of treatment. Dosing groups included 100 mg every 12 weeks (q12w) and 400 mg every 24 weeks (q24w), along with a third low-dose group (100 mg q24w) and a placebo group; administration was described as subcutaneous. For the primary endpoint, the company reported placebo-adjusted AAER reductions of 56% (p<0.0003) for 100 mg q12w and 39% (p<0.02) for 400 mg q24w versus placebo, which it described as statistically significant.

Supportive outcomes highlighted week-60 placebo-adjusted changes in lung function and exhaled nitric oxide. Upstream Bio reported placebo-adjusted FEV1 improvements at week 60 of 122 mL for 100 mg q12w and 139 mL for 400 mg q24w, alongside placebo-adjusted FeNO reductions at week 60 of 20.4 ppb (p<0.0003) and 26.3 ppb (p<0.0001), respectively. The company also stated that the third low-dose group (100 mg q24w) showed a statistically significant effect on AAER but did not provide consistent improvements in other endpoints.

Verekitug was generally well tolerated across all active doses, with a safety profile described as consistent with prior studies. Eligible participants who completed VALIANT were offered enrollment into VALOUR, a Phase 2 long-term extension (LTE) study designed to evaluate long-term safety and efficacy, and said that more than 90% of eligible patients rolled over based on current transition rates.