Glycopyrrolate/Indacaterol Maleate

LA JOLLA, Calif.--(BUSINESS WIRE)--AeroRx Therapeutics, Inc., a clinical-stage biopharmaceutical company developing proprietary nebulized combination therapies for chronic respiratory diseases, today announced the closing of a $21 million Series A financing led by Avalon BioVentures, with participation from Correlation Ventures, Alexandria Venture Investments, and others. Proceeds will support late-stage clinical development of AeroRx’s lead candidate, inhaled AERO-007, the first nebulized LABA/LAMA combination in development as a potential first-line maintenance therapy for chronic obstructive pulmonary disease (COPD). “With this Series A financing, we are well positioned to advance AERO-007 into a Phase 2b dose-optimization study and prepare for late-stage, NDA-enabling development,” said Ahmet Tutuncu, M.D., Ph.D., Co-founder and CEO of AeroRx Therapeutics. Data from a completed Phase 2a clinical study of AERO-007 demonstrated that AERO-007 was well tolerated in patients with moderate to severe COPD, and provided rapid-onset, and clinically meaningful, sustained bronchodilation through 24 hours at both low and high doses. “With this Series A financing, we are well positioned to advance AERO-007 into a Phase 2b dose-optimization study and prepare for late-stage, NDA-enabling development,” said Ahmet Tutuncu, M.D., Ph.D., Co-founder and Chief Executive Officer of AeroRx Therapeutics. “Our Phase 2a study data further support AERO-007’s potential as a once-daily nebulized LABA/LAMA combination, designed to address a major unmet need for underserved COPD patients.” “Dual bronchodilation via handheld inhalers is the standard of care, but millions of patients remain poorly controlled due to difficulties with inhaler technique,” said Jay Lichter, Ph.D., Managing Partner at Avalon BioVentures. “AeroRx has the opportunity to deliver meaningful clinical benefit by bringing the preferred guideline therapy to patients in a nebulized form that is designed for full dosing and improved adherence.” 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. 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 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). 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 potential nebulized LABA/LAMA fixed-dose combination drug in clinical development as a potential 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 potential 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.