AeroRx Therapeutics announced that a Phase 2a trial of its AERO-007 indacaterol / glycopyrrolate inhalation solution demonstrated statistically significant improvements FEV1 versus placebo for both doses studied. According to the company, the inhalation solution is delivered “via a 510(k)-cleared standard jet nebulizer.” In 2022, AeroRx said that it had partnered with HCMed on development of a nebulized LABA/LAMA inhalation solution delivered by HCMed’s AdheResp breath-actuated nebulizer.
The Phase 2a trial enrolled 16 COPD patients with moderate-to-severe disease who received either a low single dose of AERO-007 or a high single dose of AERO-007 or a single dose of an inhaled placebo. AeroRx says that the formulation “was well tolerated with a tolerability and systemic drug exposure profile comparable to the previously approved drugs with the individual active components.”
AeroRx Therapeutics CEO Ahmet Tutuncu commented, “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. 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. 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.”
Read the AeroRx Therapeutics press release
