Apogee Therapeutics reports data from Phase 1b trial of APG808

Apogee Therapeutics (APGE) announced positive interim data from its Phase 1b trial of APG808, a novel half-life extended IL-4Ralpha antibody, in patients with mild-to-moderate asthma. “Today’s results from the APG808 Phase 1b trial mark a significant milestone in its clinical development, as APG808 demonstrated a favorable safety profile and encouraging initial efficacy in patients with asthma,” said Michael Henderson, CEO of Apogee. The Phase 1b double-blind, placebo-controlled, multiple-dose trial evaluated the safety and tolerability of APG808 in 22 adult patients with mild-to-moderate asthma. The trial also evaluated fractional exhaled nitric oxide concentration, TARC, and pSTAT6. Participants were randomized 3:1, receiving 600mg of APG808 or placebo on day 1 and day 29. Key results include: Multiple dose regimen of APG808 was well tolerated in asthmatic patients through 12 weeks of available follow-up; the most common treatment-emergent adverse events, or TEAEs, observed were headache, injection site erythema, and upper respiratory tract infections; there were no Grade 3 TEAEs or severe adverse events. No adverse events led to study discontinuation; ,ultiple doses of APG808 resulted in rapid suppression of FeNO, a biomarker of Type 2 inflammation that is associated with exacerbations in asthma, with a maximal robust FeNO decrease from baseline of 53% and sustained FeNO decrease from baseline of 50% at 12 weeks. APG808 also demonstrated sustained and near-complete reduction in pSTAT6 as well as deep reduction of TARC maintained through 12 weeks, two key Type 2 inflammatory biomarkers.