Press Release
AeroRx Therapeutics Presents Modeling-Based Population Pharmacokinetics and Efficacy Analyses Supporting Once-Daily Dosing of Inhaled AERO-007 for COPD at ERS Congress 2026
- Population PK modeling supports AERO-007 120/60 µg administered once daily via nebulization, with comparable or lower steady-state systemic PK exposures versus Utibron Neohaler DPI 27.5/15.6 µg administered twice daily
- Analysis builds on positive Phase 2a data demonstrating clinically meaningful bronchodilation sustained through 24 hours
- Modeling supports dose selection for AeroRx’s planned Phase 2b study
La Jolla, Calif., May 18, 2026 – AeroRx Therapeutics, Inc., a clinical-stage biopharmaceutical company developing proprietary nebulized combination therapies for chronic respiratory diseases, today announced that population pharmacokinetic (PK) modeling and efficacy analyses for inhaled AERO-007 will be presented at the European Respiratory Society (ERS) Congress 2026 taking place September 5-9 in Barcelona, Spain. AERO-007 is a fixed-dose combination of indacaterol and glycopyrrolate in clinical development for COPD and being evaluated for once-daily dosing via nebulization. The model-based population PK analysis was conducted to predict steady-state systemic drug exposure following repeat dosing and help inform dose selection for the next stage of clinical development.
“These analyses build on the 24-hour bronchodilation we observed in our Phase 2a study and provide additional support for the potential of once-daily AERO-007,” said Ahmet Tutuncu, M.D., Ph.D., Co-founder and Chief Executive Officer of AeroRx Therapeutics. “The modeling-based PK findings, together with the Phase 2a efficacy response, help define the dose and dosing strategy we are taking forward into Phase 2b as we continue to advance AERO-007, our nebulized dual bronchodilator LABA+LAMA combination, for COPD patients who require or prefer nebulized treatment.”
The model predicted that steady-state PK exposures for indacaterol (LABA) and glycopyrrolate (LAMA) are reached by Day 14 following once-daily dosing. In addition, the model predicted thatAERO-007 120/60 µg administered once daily via nebulization would provide comparable or lower steady-state systemic exposures compared to the reference drug, Utibron Neohaler DPI 27.5/15.6 µg administered twice daily, which align with the well-established systemic safety profile of indacaterol and glycopyrrolate combination treatment in COPD patients. Modeling across the evaluated dose range also supported selection of 120/60 µg of AERO-007 as the highest dose for AeroRx’s planned Phase 2b dose-optimization study.
The population PK analysis builds on AeroRx’s previously reported randomized, double-blind, placebo-controlled Phase 2a study in 16 patients with COPD. In the study, AERO-007 at both dose levels, 100/50 µg and 200/100 µg, demonstrated a clinically meaningful and statistically significant bronchodilator response that was sustained through 24 hours, supporting evaluation of a once-daily dosing regimen. Both dose levels demonstrated statistically significant (p<0.001) and clinically meaningful (>100 mL) improvements in FEV₁ compared with placebo throughout the 24-hour post-dose period. All treatments were well tolerated at both dose levels, with no severe or serious adverse events and no adverse events leading to treatment discontinuation.
AeroRx is preparing to initiate a Phase 2b study to evaluate repeat dosing and further define the dose and dosing schedule of inhaled AERO-007 for late-stage clinical development.
The data are being presented at ERS Congress 2026 in a poster (Abstract 61754) titled, “Efficacy and population PK model of inhaled AERO-007 (indacaterol/glycopyrrolate), a nebulized once daily LABA+LAMA combination therapy for patients with 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).
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
Aerox 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 whoremain 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.
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Bryce Suchomel
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