Glycopyrrolate/Indacaterol Maleate

A respiratory biotech that launched Tuesday morning aims to take advantage of excitement in COPD drug development spurred by two recent deals. AeroRx Therapeutics took the wraps off a $21 million Series A that it’s using to get its lead program through Phase 2b testing in chronic obstructive pulmonary disease, or COPD. It’s the same category that spurred Merck’s $10 billion acquisition of Verona Pharma and GSK’s partnership with Hengrui Pharma that could be worth $12 billion if everything pans out. The AeroRx drug, known as AERO-007, is a nebulized reformulation of two approved compounds — indacaterol and glycopyrrolate — that use different mechanisms of action. Indacaterol is a long-acting beta agonist (LABA), while glycopyrrolate is a long-acting muscarinic agonist (LAMA). Combining LABAs and LAMAs is common when treating COPD. AeroRx CEO Ahmet Tutuncu said the FDA has approved five such products. An inhaler combination of indacaterol and glycopyrrolate was approved in 2015 as Utibron, which was developed by Novartis and out-licensed to Sunovion Pharmaceuticals a year later. (Sunovion is now owned by Sumitomo Pharma.) All the approvals are for inhalers with dry powder, which is more difficult for older and sicker patients to use, Tutuncu said. AeroRx believes it can be the first company to offer a nebulized formulation as a first-line maintenance therapy in COPD. “It’s a different delivery technology, or full dose delivery, for those patients who need to be on nebulized medicines,” Tutuncu said. “A significant number of COPD patients who are typically getting older, they are on inhalers, but they are the ones who end up in hospitals with exacerbations for symptom control, and therefore they need to be on nebulized medicine.” So far, AeroRx has run a small Phase 2a study with 16 patients that suggested AERO-007 could be dosed once daily. In the Phase 2b trial, researchers plan to test once-daily and twice-daily doses. Most other details about the trial remain undisclosed until after discussions with the FDA, according to Tutuncu, including how long it’s expected to last. But because both components of AERO-007 are already approved, Tutuncu expects an “abbreviated” late-stage development process comprising the Phase 2b and Phase 3 trials. The trials will also enroll all COPD patients, and if AERO-007 wins approval, AeroRx plans to market it for patients older than 65 years old. The company also has another preclinical program called AERO-111, which is a triple combination nebulized COPD treatment. (There are two approved triple-combo inhalers.) In addition to a LABA and LAMA compound, AERO-111 also includes a corticosteroid. Tutuncu said the company is still figuring out which one to use. AeroRx’s Series A comes about 18 months after it closed a $6 million seed round in the spring of last year. With the new cash in hand, AeroRx is aiming to capitalize on the recent momentum in COPD following the Merck and GSK deals. “Those were two really important validation points for the interest from big pharma for nebulized delivery in the respiratory space, and particularly in the COPD space,” Tutuncu said. “We’re very excited about that potential for collaboration with pharma down the road.”

Two months after posting proof-of-concept data supporting its nebulised approach to treating chronic obstructive pulmonary disease (COPD), AeroRx Therapeutics has bagged a $21-million series A to kick off a Phase IIb trial of AERO-007.The biotech's candidate is poised to become the first nebulised combination of a long-acting beta agonist (LABA) and a long-acting muscarinic antagonist (LAMA) for first-line maintenance treatment of COPD, CEO Ahmet Tutuncu told FirstWord. While dual LABA/LAMA bronchodilation delivered via handheld inhaler is the standard first-line therapy, a subset of patients with COPD can't effectively use the devices, or prefer nebulised treatments, he explained."Up to 75% of COPD patients, particularly older and sicker individuals, do not receive the optimal dose from inhalers, leading to poor symptom control, more frequent exacerbations, and hospitalisations," Tutuncu said. "By contrast, nebulised delivery is designed to provide the full intended dose regardless of disease severity or patient technique, using normal, passive breathing. This ensures more consistent drug delivery, improves adherence, and gives the patients and clinicians greater confidence that patients are receiving effective therapy."However, there are no approved nebulised LABA/LAMA combinations — and that's where AeroRx and AERO-007 come in. In July, the company reported results from a Phase IIa study showing that in 16 adults with moderate-to-severe COPD, both low- and high-doses of AERO-007 led to clinically meaningful, statistically significant improvements in forced expiratory volume in one second compared with placebo, with rapid-onset and sustained 24-hour bronchodilation.Additionally, the treatment was well tolerated, with a systemic drug exposure profile similar to that of other LABAs and LAMAs. With the proceeds from the series A — led by Avalon BioVentures, with participation from Correlation Ventures and Alexandria Venture — AeroRx plans to launch a Phase IIb dose-optimisation study in early 2026. The 14-day, placebo-controlled crossover study will randomise patients with COPD to evaluate once- versus twice-daily dosing, and to select the dosage of AERO-007 for Phase III testing. "Our goal has always been simple: ensure that every patient can receive the best-in-class treatment their condition demands, regardless of their ability to use an inhaler," Tutuncu said. "This financing moves us closer to that vision."