Aero-007 demonstrated significant lung function improvements over 24 hours in patients with moderate-to-severe COPD.
RT’s Three Key Takeaways:
- Nebulized Dual Therapy: Aero-007 is the first fixed-dose combination of a long-acting beta-agonist and a long-acting muscarinic antagonist in development for delivery via a standard jet nebulizer.
- Sustained Efficacy: Data from the Phase 2a study showed that the treatment provided statistically significant and clinically meaningful lung function improvements that lasted through 24 hours.
- Safety Profile: The combination was well tolerated at both tested dose levels, with most adverse events reported as mild and none leading to treatment discontinuation.
AeroRx Therapeutics presented positive Phase 2a data for Aero-007, the first potential nebulized long-acting beta-agonist (LABA) and long-acting muscarinic antagonist (LAMA) fixed-dose combination in clinical development for COPD. Findings were presented at ATS 2026.
The Phase 2a clinical trial was a randomized, double-blind, placebo-controlled, single-dose, three-period crossover study that evaluated the safety, tolerability, and efficacy of Aero-007 in 16 patients with moderate-to-severe COPD. Participants received two dose levels of Aero-007 or a placebo using an LC Sprint standard jet nebulizer, and pulmonary function was assessed by serial spirometry over 24 hours after dosing.
Aero-007 demonstrated statistically significant and sustained improvements in lung function compared to placebo at both dose levels, according to the presented data. The placebo-adjusted standardized forced expiratory volume in one second (FEV1) AUC0-24h was 251 mL for the Aero-007 100/50 µg dose and 262 mL for the Aero-007 200/100 µg dose (p<0.001). Placebo-adjusted peak change from baseline in FEV1 was 311 mL and 302 mL, respectively.
“Dual bronchodilation is a central part of COPD maintenance therapy, but delivery remains an important barrier for many patients,” said Dave Singh, MD, professor of respiratory medicine and clinical pharmacology at the University of Manchester and principal investigator of the study. “In this Phase 2a study, nebulized Aero-007 demonstrated rapid, clinically meaningful bronchodilation that was sustained over 24 hours, supporting the potential of a once-daily nebulized LABA+LAMA fixed-dose combination approach for patients who may not receive the full benefit of handheld inhaler-based treatment.”
Aero-007 combines the long-acting, FDA-approved bronchodilators indacaterol and glycopyrrolate in a proprietary formulation. The company reported that systemic pharmacokinetic exposures to these agents were similar to or below exposures reported with existing handheld reference drugs. The treatment was well tolerated at both dose levels, with most treatment-emergent adverse events reported as mild and no events leading to treatment discontinuation.
According to the source material, more than 16 million people in the US are diagnosed with COPD. While many patients use maintenance therapy delivered via handheld inhalers, up to 50% remain symptomatic. Research indicates that up to 75% of patients do not receive the full therapeutic dose from handheld devices, which require specific coordination and forceful inhalation.
“These data strengthen our confidence in Aero-007 as a potential first-line maintenance, once-daily LABA+LAMA bronchodilator therapy for COPD patients who need or prefer nebulized treatment,” said Ahmet Tutuncu, MD, PhD, cofounder and chief executive officer of AeroRx Therapeutics. “By combining two clinically validated bronchodilators in a proprietary formulation delivered through a standard jet nebulizer, we believe AERO-007 has the potential to address this significant gap in COPD care.”
Nebulized delivery provides a passive-breathing alternative that may offer more consistent dosing and symptom control for patients who find handheld inhalers challenging, particularly older adults and those with advanced COPD. AeroRx Therapeutics plans to advance the program into the next stage of clinical development.
