Aer Therapeutics has announced that a Phase 2a trial of fexlamose (AER-01) inhalation solution in patients with moderate-to-severe COPD failed to meet primary or secondary endpoints and also demonstrated an increased incidence of adverse events compared to placebo. The company announced the initiation of the study in January 2025 and said at the time that a previous Phase 1 trial in healthy volunteers had demonstrated safety and tolerability. The trial was supported by $36 million raised in a 2023 Series A financing round.
According to Aer, the study, which had been expected to enroll approximately 100 COPD patients, actually enrolled 119. Patients received either 90 mg of nebulized fexlamose or a placebo inhalation solution once a day for 28 days, with the primary endpoint as change in FEV1 from baseline at Week 4. The company says that adverse events associated with the fexlamose inhalation solution included COPD exacerbations and led to discontinuation of treatment.
Aer Therapeutics founder and Chief Clinical Consultant John Fahy commented, “I am deeply grateful for the investor support that enabled Aer’s Phase 2a clinical trial of fexlamose in COPD patients with mucus plugs. Although the primary endpoint was not met, this study yielded high-value data that will advance our understanding of mucus plug pathology in COPD and other lung diseases. I want to extend my sincere thanks to the Aer team, our clinical site investigators, and especially the trial participants for ensuring the timely completion of the trial.”
Executive Chairman Thomas P. Mathers added, “We are disappointed by the results of this proof-of-concept trial, but proud to have investigated the potential benefits of a muco-active drug like fexlamose in COPD.”
Read the Aer Therapeutics press release
