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 positive Phase 2a proof-of-concept results for its lead candidate inhaled AERO-007, which is in development as a first-line maintenance therapy combining a long-acting beta2 agonist (LABA) and long-acting muscarinic antagonist (LAMA) for the treatment of chronic obstructive pulmonary disease (COPD). Topline data showed that AERO-007 was well tolerated with rapid-onset and sustained 24-hour bronchodilation at both low and high doses. AeroRx plans to present the full dataset at an upcoming scientific conference.
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 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 for patients who find inhalers challenging, particularly older adults and those with advanced COPD, who are at high risk for exacerbations, hospitalization, and disease progression (3).
“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,” said Dr. Dave Singh, principal investigator of the Phase 2a study and Professor of Respiratory Medicine and Clinical Pharmacology, University of Manchester, United Kingdom.
“With AERO-007, a proprietary formulation that combines two FDA-approved, clinically validated bronchodilators delivered via a reimbursable, standard jet nebulizer, we aim to bring a best-in-class nebulized combination treatment to the market to address a major need for underserved COPD patients,” said Ahmet Tutuncu, M.D., Ph.D., Co-founder and Chief Executive Officer of AeroRx Therapeutics.
The Phase 2a clinical 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 improvements in forced expiratory volume in one second (FEV1, the standard efficacy parameter based on serial spirometry assessment) compared to placebo. Inhaled AERO-007 was well tolerated with a tolerability and systemic drug exposure profile comparable to the previously approved drugs with the individual active components.
“The magnitude and durability of our Phase 2a signal underscores AERO-007’s potential to offer a best-in-class fixed-dose combination bronchodilator as a first-line standard-of-care in COPD,” continued Dr. Tutuncu. “We look forward to presenting the full data set at an upcoming scientific conference and advancing inhaled AERO-007 into a late-stage, NDA-enabling clinical program.”
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
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 drug 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, www.aerorxtx.com.
Contacts
Company: Bryce Suchomel, info@aerorxtherapeutics.com
Media: Jessica Yingling, Ph.D., Little Dog Communications, jessica@litldog.com
