glycopyrrolate/indacaterol (AERO-007) / AeroRx Therapeutics - LARVOL DELTA

Efficacy and population PK model of inhaled AERO-007 (indacaterol/glycopyrrolate), a nebulized once daily LABA+LAMA combination therapy for patients with COPD (ERS 2026) - "Inhaled AERO-007 (100/50μg) via nebulization generated a robust bronchodilator response representing a best-in-class LABA+LAMA combination for once daily dosing with lower systemic exposure compared to the same LABA+LAMA combination administered twice daily via DPI inhaler (27.5/15.6ug)."

Clinical • Combination therapy • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

Phase 1 PK Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: AeroRx Therapeutics Inc.

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Phase 2a, Randomized, Double-blind, Placebo-controlled Study of Inhaled Aero-007, a Novel Inhalation Solution Formulation of LABA and LAMA Combination (Indacaterol And Glycopyrrolate) for Nebulization Delivery in COPD (ATS 2026) - No abstract available

Clinical • P2a data • Chronic Obstructive Pulmonary Disease • Immunology • Respiratory Diseases

AeroRx Therapeutics Announces $21 Million Series A Financing to Advance Inhaled AERO-007, the First Nebulized LABA/LAMA for COPD, into Late-Stage Clinical Development (Businesswire)

Financing • Chronic Obstructive Pulmonary Disease

Phase 1/Phase 2a Study of AERO-007 Inhalation Solution, a Nebulized LABA/LAMA Combination for Maintenance Treatment of COPD (clinicaltrials.gov) - P1/2 | N=24 | Completed | Sponsor: AeroRx Therapeutics Inc. | Active, not recruiting ➔ Completed

Trial completion • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

AeroRx Therapeutics Announces Topline Positive Phase 2a Data for Inhaled AERO-007, the First Nebulized LABA/LAMA Combination in Development for COPD (Businesswire) - P1/2a | N=24 | NCT06841640 | Sponsor: AeroRx Therapeutics Inc. | "AeroRx Therapeutics...announced positive Phase 2a proof-of-concept results for its lead candidate inhaled AERO-007....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....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..."

P2a data • Chronic Obstructive Pulmonary Disease

Phase 1/Phase 2a Study of AERO-007 Inhalation Solution, a Nebulized LABA/LAMA Combination for Maintenance Treatment of COPD (clinicaltrials.gov) - P1/2 | N=24 | Active, not recruiting | Sponsor: AeroRx Therapeutics Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Phase 1/Phase 2a Study of AERO-007 Inhalation Solution, a Nebulized LABA/LAMA Combination for Maintenance Treatment of COPD (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: AeroRx Therapeutics Inc.

New P1/2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases