Glycopyrrolate/Indacaterol Maleate

AERO-007 demonstrated rapid, sustained, statistically significant, and clinically meaningful bronchodilation through 24 hours in patients with moderate-to-severe COPD Treatment with AERO-007 was well tolerated at both dose levels, with most adverse events mild and no adverse events leading to treatment discontinuation Data support continued development of AERO-007 as a potential once-daily, first-line maintenance therapy for COPD patients who require or prefer nebulized treatment LA JOLLA, Calif.--(BUSINESS WIRE)-- #Biotech -- AeroRx Therapeutics, Inc. , a clinical-stage biopharmaceutical company developing proprietary nebulized combination therapies for chronic respiratory diseases, today announced the presentation of positive Phase 2a data for inhaled AERO-007, the first potential nebulized LABA+LAMA fixed-dose combination in clinical development for chronic obstructive pulmonary disease (COPD). The data were presented at the American Thoracic Society (ATS) 2026 International Conference. The data support AERO-007’s continued development as a potential first-line maintenance dual bronchodilation therapy for COPD patients who require or prefer nebulized treatment, with both dose levels demonstrating robust and sustained improvements in lung function and a favorable tolerability profile. “Dual bronchodilation is a central part of COPD maintenance therapy, but delivery remains an important barrier for many patients,” said Dave Singh, M.D., Professor of Respiratory Medicine and Clinical Pharmacology at the University of Manchester and principal investigator of the Phase 2a 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.” The Phase 2a clinical trial was a randomized, double-blind, placebo-controlled, single-dose, three-period crossover, dose-ranging study evaluating the safety, tolerability, pharmacokinetics, and efficacy of AERO-007 in 16 patients with moderate-to-severe COPD. Participants received AERO-007 100/50 μg, AERO-007 200/100 μg, and placebo, separated by a washout period. Treatments were administered 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, including placebo-adjusted standardized FEV₁ AUC 0-24h of 251 mL for AERO-007 100/50 μg and 262 mL for AERO-007 200/100 μg, both p<0.001. Placebo-adjusted peak change from baseline in FEV₁ was 311 mL and 302 mL, respectively, representing a robust, clinically meaningful bronchodilation, and systemic pharmacokinetic exposures to indacaterol and glycopyrrolate were similar to or below exposures reported with reference drug Utibron Neohaler DPI (27.5/15.6 μg twice daily). AERO-007 was well tolerated at both dose levels, with most treatment-emergent adverse events mild and no adverse events leading to treatment discontinuation. “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, M.D., Ph.D., Co-founder and Chief Executive Officer of AeroRx Therapeutics. “Patients in this segment have not had access to guideline-preferred LABA+LAMA combination therapy in a fixed-dose nebulized formulation. 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. I am grateful to the patients, investigators, advisors, and AeroRx team who made this study possible, and we look forward to advancing the program into the next stage of clinical development.” The data were presented on May 17, 2026, by Dr. Tutuncu at ATS 2026 International Conference in a poster titled, “Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of Inhaled AERO-007, a Novel Inhalation Solution of LABA+LAMA Combination (Indacaterol + Glycopyrrolate) for Nebulization Delivery in COPD.” About AERO-007 AERO-007 combines the long-acting, FDA-approved bronchodilators indacaterol (LABA) and glycopyrrolate (LAMA) in a proprietary formulation for delivery via a 510(k)-cleared standard jet nebulizer. More than 16 million people in the United States are diagnosed with COPD, posing a significant economic and social burden, and as many as 50 percent remain symptomatic even while using FDA-approved LABA+LAMA maintenance therapy delivered via handheld inhalers (1). Studies also show that up to 75 percent of patients do not receive the full therapeutic dose from handheld inhaler devices, which demand coordination and forceful inhalation (2). Nebulized delivery offers a passive-breathing alternative that can provide more consistent dosing and better symptom control for patients who find handheld inhalers challenging, particularly older adults and those with advanced COPD, who are at high risk for exacerbations, hospitalization, and disease progression (3,4). References: (1) American Lung Association , accessed July 24, 2025; Boers et al. JAMA Network Open 2023; Molimard et al. Eur Respir J 2017 (2) Kocks et al. BMC Pulm Med 2023 (3) Crater et al. Ther Adv Respir Dis 2022; Barjaktarevic et al. Int J COPD 2020; Melamed et al. Int J COPD 2026. About AeroRx Therapeutics AeroRx Therapeutics is a clinical-stage biopharmaceutical company developing proprietary, combination products for nebulized delivery to improve the treatment of chronic respiratory diseases. The company’s lead product candidate, inhaled AERO-007, is the first nebulized LABA+LAMA fixed-dose combination bronchodilator in clinical development as a first-line maintenance therapy for COPD and has the potential to help millions of patients who remain symptomatic, or poorly served, under existing drugs delivered via handheld inhalers or nebulized LABA or LAMA monotherapy. A second program, AERO-111, is in development as the first nebulized LABA+LAMA+ICS triple therapy, for patients who escalate beyond dual bronchodilators. AeroRx’s leadership team has decades of expertise in aerosol drug delivery, clinical development, and regulatory strategy and guided multiple respiratory therapies from concept to regulatory approval. AeroRx is headquartered in the Avalon BioVentures Accelerator in La Jolla, California. For more visit, . Contacts Company: Bryce Suchomel, info@aerorxtherapeutics.com Media: Jessica Yingling, Ph.D., Little Dog Communications , jessica@litldog.com