Verekitug Lowers Severe Asthma Exacerbation Rate

September 09, 2026 at 12:28

Verekitug 100mg administered every 12 weeks, reduced the annualized asthma exacerbation rate (AAER) by 56% compared with placebo among adults with severe asthma in the phase 2 VALIANT trial, according to Upstream Bio's company-reported findings presented at the European Respiratory Society Congress 2026. The difference was statistically significant (P<.001), and the study met its primary endpoint across all dose regimens evaluated.

VALIANT was a global, randomized, double-blind, placebo-controlled, dose-ranging, parallel-group trial involving 478 adults with severe asthma. Enrollment was not restricted by baseline blood eosinophil count or other type 2 biomarker levels. All participants received treatment for at least 24 weeks, with some treated for up to 60 weeks depending on when they entered the study.

Verekitug is a recombinant, fully human immunoglobulin G1 monoclonal antibody that binds the thymic stromal lymphopoietin (TSLP) receptor and inhibits TSLP-initiated proinflammatory signaling. Upstream Bio also reported statistically significant AAER reductions in the other 2 active-dose groups.

At week 24, verekitug improved forced expiratory volume in 1 second (FEV1), fractional exhaled nitric oxide (FeNO), and asthma symptom control measured with the Asthma Control Questionnaire (ACQ-6) compared with placebo. Improvements across these key secondary outcomes were observed as early as week 2. The company said verekitug was generally well tolerated across active doses and that immunogenicity had no meaningful effect on safety or efficacy results.

Upstream Bio plans to initiate phase 3 trials in severe asthma and chronic rhinosinusitis with nasal polyps in the first quarter of 2027. The planned trials will evaluate verekitug 400mg every 12 weeks against placebo in broad populations without enrollment restrictions based on baseline biomarkers.