Aer Therapeutics’ nebulised drug has failed to show benefit in a Phase IIa chronic obstructive pulmonary disease (COPD) trial.
The randomised, double-blind, placebo-controlled AER-01-002 trial (NCT06731959), evaluating 90 mg of fexlamose administered daily via nebuliser in moderate–to–severe COPD patients, did not achieve its primary or secondary endpoints of efficacy.
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Fexlamose was also associated with a higher incidence of respiratory adverse events compared with placebo, including COPD exacerbations and adverse events (AEs) that led to treatment discontinuation.
Conducted in Australia, New Zealand, the UK, Poland, Spain and Bulgaria, the study enrolled 119 moderate-to-severe COPD patients, with over 75% of patients with either severe or very severe airflow limitation as classified by their Global Initiative for Chronic Obstructive Lung Disease (GOLD) status.
Dr John Fahy, founder and chief clinical consultant at Aer Therapeutics, said: “I am deeply grateful for the investor support that enabled Aer’s Phase IIa 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.”
Fexlamose is an inhaled thiol-based therapeutic agent designed to liquefy mucus plugs by cleaving the chemical disulfide bonds that thicken mucus. Aer Therapeutics hoped for positive data as mucus plugs are present in up to half of moderate-to-severe COPD and asthma patients, responsible for reducing lung function, impairing quality of life, and increasing mortality.
Aer also had hopes for the drug in asthma, non-CF bronchiectasis and cystic fibrosis; however, it is not currently clear whether the drug will continue development in these indications.
According to a GlobalData report, the COPD market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is forecast to grow from $11.6bn in 2023 to $30.2bn by 2033, representing a compound annual growth rate (CAGR) of 10%.
Analysts project that a significant driver for this growth is the approval of biologics, such as Sanofi and Regeneron’s Dupixent (dupilumab), which was the first biologic therapy approved for COPD. Dupixent’s patent is scheduled to expire in 2031, however, opening the door for competitors.
GlobalData is the parent company of Clinical Trials Arena.
Another drug showing promise is AstraZeneca’s tozorakimab, which has succeeded in several Phase III COPD trials. Tozorakimab, which is also being investigated in asthma, is a potential first-in-class monoclonal antibody (mAb) targeting interleukin-33 (IL-33).
