Biopharmaceutical company AeroRx Therapeutics Inc. has announced positive proof-of-concept results for its combination long-acting beta2 agonist (LABA) and long-acting muscarinic agonist (LAMA) for the treatment of COPD.
The company said in a news release that the initial data from the phase 2a study showed that the treatment, known as AERO-007, was well tolerated with rapid-onset and sustained 24-hour bronchodilation at both low and high doses. AeroRx said it will present the full dataset at a future date.
The AERO-007 treatment combines the FDA-approved bronchodilators indacaterol (LABA) and glycopyrrolate (LAMA) in a proprietary formulation that is delivered via a jet nebulizer. According to the news release, nebulized delivery — as opposed to delivery through a handheld inhaler — offers a passive breathing alternative that can provide more consistent dosing. This can be particularly useful for older adults and those with advanced COPD who are at higher risk for exacerbations, hospitalization and disease progression.
Dave Singh, MD, principal study investigator and professor of respiratory medicine and clinical pharmacology at the University of Manchester, United Kingdom, said the results could help fill a gap in COPD treatment.
“Current guidelines recommend dual bronchodilators as first-line therapy in COPD patients, but no LABA/LAMA combinations are available via nebulizer, leaving a critical gap in real-world use for many COPD patients who prefer or need to be on nebulized treatments for optimal drug delivery and improved outcomes,” he said.
The phase 2a trial was a randomized, double-blind, placebo-controlled, single-dose, three-period crossover that enrolled 16 adults with moderate to severe COPD. Both the low- and high-dose treatments of AERO-007 delivered clinically meaningful, statistically significant improvement in forced expiratory volume in one second (FEV1) compared to placebo.
