Apogee Therapeutics Reports Positive Phase 1b Trial Results for APG808 in Asthma Patients

Apogee Therapeutics, Inc., a clinical-stage biotechnology firm, recently announced promising interim data from its Phase 1b trial of APG808, a novel antibody, in patients with mild-to-moderate asthma. This development marks a significant milestone in the treatment of asthma, a common non-communicable disease impacting millions globally.

The Phase 1b trial was a double-blind, placebo-controlled, multiple-dose study involving 22 adult patients. The primary focus was on assessing the safety and tolerability of APG808, alongside evaluating the fractional exhaled nitric oxide concentration (FeNO), TARC, and pSTAT6 – indicators of asthma activity. Participants were randomized to receive either 600mg of APG808 or a placebo on days 1 and 29.

Results from the trial demonstrated that multiple doses of APG808 led to a rapid suppression of FeNO, a biomarker associated with Type 2 inflammation. Specifically, there was a significant maximal FeNO decrease from baseline by 53%, indicating the potential for APG808 to provide durable asthma disease control. Impressively, this suppression was sustained with a 50% reduction from baseline persisting at 12 weeks. Such results suggest that APG808 could transform asthma treatment with dosing every two months or potentially even less frequently, contrasting with the current biweekly standard of care.

APG808 is a subcutaneous extended half-life monoclonal antibody targeting IL-4Rα, a clinically validated target across several allergic diseases. It has been engineered for its potential use in treating asthma, COPD, and other inflammatory and immunological indications. The antibody's pharmacokinetic profile indicates the potential for extended maintenance dosing every two to three months, which could substantially enhance clinical outcomes and patient compliance.

In preclinical studies, APG808 showed similar binding affinity to IL-4Rα as DUPIXENT, another well-known treatment, and demonstrated comparable inhibition effects. This promising profile underscores APG808's capability to challenge existing treatment paradigms in asthma care.

Apogee's CEO, Michael Henderson, M.D., remarked on the favorable safety profile and initial efficacy of APG808, suggesting that this advancement could redefine asthma treatment. Henderson highlighted the antibody's potential to improve patient outcomes significantly over the current standard of care, reinforcing the company's commitment to creating a leading inflammatory and immunology (I&I) company.

Apogee Therapeutics is focused on developing innovative biologics with potential for differentiated efficacy and dosing across the largest I&I markets. Their programs aim to address the limitations of current therapies by leveraging well-established mechanisms of action and advanced antibody engineering to optimize properties such as half-life. With a portfolio featuring four validated targets, Apogee is working towards achieving best-in-class efficacy and dosing through both monotherapies and combinations of its novel antibodies.

The positive data from the APG808 Phase 1b trial aligns with Apogee's broader goal of delivering meaningful benefits to patients who are currently underserved by existing treatment standards. As the company continues to build on its robust pipeline and expertise, it aims to provide substantial value and transformative options for patients worldwide.