Aer Therapeutics has announced the initiation of the AER-01-002 Phase 2a proof-of-concept study of nebulized fexlamose (formerly AER-01) in COPD patients with high mucus plug scores. The trial is expected to enroll 100 patients with moderate-to-severe COPD who will receive daily fexlamose for 28 days. Aer said that it expects to have top-line data available in January 2026.
In April 2023, Aer announced that it had raised $36 million in Series A financing for development of the inhaled thiol-saccharide mucolytic, which the company says could be delivered either as an inhalation solution or as a dry powder. According to the company, a previous Phase 1 SAD/MAD trial of fexlamose in healthy volunteers demonstrated good safety and tolerability.
Aer founder and Chief Clinical Consultant John Fahy commented, “We are highly encouraged by the rapid start-up of AER-01-002 and enrollment of our first patient in Australia. Our clinical investigators are very excited by the novel approach Aer is taking with fexlamose to potentially improve lung function and symptoms in COPD patients with moderate to severe disease. These patients have a large unmet medical need and targeting mucus plugs represents a rational and differentiated approach to increase their lung function and improve their lung health. We expect to complete AER-01-002 by the end of this year.”
Read the Aer Therapeutics press release
