Trial begins for potential COPD, asthma treatment

Photo of a doctor giving an older woman a shot.

Apogee Therapeutics has dosed the first patients in its phase 1 clinical trial for APG333, its novel half-life extended monoclonal antibody targeting thymic stromal lymphopoietin (TLSP).

The company said in a news release that the antibody is initially being evaluated as a treatment for COPD, asthma and other inflammatory and immunology conditions.

Carl Dambkowski, MD, chief medical officer of Apogee, said the initiation of the APG333 phase 1 clinical trial marks Apogee’s fourth program to enter clinical trials in less than 18 months and represents an important step in the company’s pipeline evolution.

“TLSP is a clinically validated target that plays an important role in both Type 2 and Type 3 inflammation, the primary drivers of respiratory conditions,” Dr. Dambkowski said. “Based on its mechanism, it has the potential to broadly address obstructive respiratory diseases, including approximately half of patients with low Type 2 inflammatory respiratory diseases who currently have fewer treatment options. We plan to initially explore APG333 for the treatment of asthma, with the ultimate goal of leveraging this investigational therapy in combination with APG777, a combination approach that could optimally address respiratory and broader I&I [inflammatory and immunology] diseases.”

The trial is designed as a double-blind, placebo controlled, first-in-human, single ascending dose trial in healthy volunteers. The study will evaluate the safety, tolerability and pharmacokinetics of APG333 and is expected to enroll approximately 32 people across four cohorts. Apogee said it expects interim data from the trial in the second half of 2025.

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