Zinger Key Points
- APG808 cut FeNO by 53% at week 12, with sustained 50% reduction, showing anti-inflammatory effect.
- No Grade 3 or severe adverse events; most common side effects included headache and mild injection reactions.
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Apogee Therapeutics, Inc. APGE on Monday revealed interim data from its Phase 1b trial of APG808, a novel half-life extended IL-4Rα antibody, in patients with mild-to-moderate asthma.
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 (FeNO), TARC, and pSTAT6.
Participants were randomized 3:1, receiving 600mg of APG808 or placebo on day 1 and day 29.
The study showed that a 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 (TEAEs) observed were headache, injection site erythema, and upper respiratory tract infections.
The company said there were no Grade 3 TEAEs or severe adverse events. No adverse events led to study discontinuation.
Also, multiple doses of APG808 resulted in rapid suppression of FeNO, a biomarker of Type 2 inflammation that is associated with asthma exacerbations. At 12 weeks, there was a maximal robust FeNO decrease from a baseline of 53% and a sustained FeNO decrease from a baseline of 50%.
APG808 also demonstrated a sustained and near-complete reduction in pSTAT6 and deep reduction of TARC, maintained through 12 weeks, two key Type 2 inflammatory biomarkers.
APG808’s optimized formulation, potential best-in-class PK profile, and durable FeNO suppression for 12 weeks support the potential for 2-month or longer maintenance dosing.
Apogee Therapeutics’ reported cash, cash equivalents, and marketable securities were $681.4 million as of March 31, 2025.
Based on current operating plans, Apogee expects its existing cash, cash equivalents, and marketable securities will enable the company to fund its operating expenses into the first quarter of 2028.
Price Action: APGE stock is up 7.80% at $40.20 at the last check on Monday.
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