New nebulized combo therapy rapidly boosts lung function in COPD
AERO-007 has potential to fill significant gap in care, developer says
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AERO-007 — a combination of two classes of bronchodilators delivered via a standard jet nebulizer — led to rapid and clinically meaningful improvements in lung function among adults with moderate-to-severe chronic obstructive pulmonary disease (COPD).
That’s according to data from the Phase 2a portion of a Phase 1/2a clinical trial (NCT06841640) that tested AeroRx Therapeutics‘ nebulized combination therapy against a placebo in adults with moderate-to-severe COPD. The results were presented at the 2026 American Thoracic Society (ATS) International Conference, held in Florida last month.
AeroRx believes the findings support continued development of AERO-007 as a potential once-daily, first-line maintenance therapy for COPD patients who prefer or require nebulized versus handheld inhaled treatment. Nebulizers use a machine to convert liquid medication into a fine mist that can be breathed in.
“Patients in this segment have not had access to guideline-preferred [LABA plus LAMA] combination therapy in a fixed-dose nebulized formulation,” Ahmet Tutuncu, MD, PhD, co-founder and CEO of AeroRx, said in a company press release. “By combining two clinically validated bronchodilators in a proprietary formulation delivered through a standard jet nebulizer, we believe AERO-007 has the potential to address this significant gap in COPD care.”
Guidelines strongly recommend combining LABA and LAMA therapy
COPD treatment usually involves bronchodilators, medications that open and relax the airways. This includes long-acting beta-two agonists (LABAs) and long-acting muscarinic antagonists (LAMAs).
LABA medications include formoterol (sold as Perforomist, among others, with generics available) and Serevent (salmeterol), while LAMA medications include tiotropium (sold as Spiriva Respimat and Spiriva) and Tudorza Pressair (aclidinium).
The ATS’ 2020 guidelines strongly recommend combining LABA and LAMA therapy over either treatment alone for COPD patients experiencing shortness of breath or limited exercise tolerance.
While several LABA/LAMA combinations are currently available as handheld inhalers, a significant number of COPD patients, particularly older and higher-risk individuals, don’t receive optimal benefit from these devices.
“Dual bronchodilation is a central part of COPD maintenance therapy, but delivery remains an important barrier for many patients,” said Dave Singh, MD, professor of respiratory medicine and clinical pharmacology at the University of Manchester in the U.K and principal investigator of the Phase 2a study.
Phase 1 determined optimal fixed dose of both bronchodilators
Nebulized delivery using a device that converts liquid medication into a fine mist offers a passive-breathing alternative for these patients. Yet, nonebulized LABA/LAMA fixed-dose combination has been approved for COPD to date.
Developed via a partnership between AeroRx and HCmed, AERO-007 combines a fixed dose of indacaterol (a LABA) and glycopyrrolate (a LAMA), both of which are approved in the U.S. as part of combination treatments. It’s delivered using a standard jet nebulizer, which is also approved by the U.S. Food and Drug Administration.
The Phase 1 portion of the trial determined the optimal fixed dose of both bronchodilators in eight healthy adult volunteers. In the Phase 2a part, 16 adults with moderate-to-severe COPD were randomly assigned to three nebulized treatments in rotating order: AERO-007 at a lower dose (100/50 micrograms), AERO-007 at a higher dose (200/100 micrograms), and a placebo. Washout periods were included between cycles to clear prior treatment from the body.
The study’s main goals were to assess the therapy’s movement into, through, and out of the body, as well as changes in lung function as measured by FEV1 (the amount of air a person can forcefully exhale in 1 second) over 24 hours after dosing.
These data strengthen our confidence in AERO-007 as a potential first-line maintenance, once-daily [LABA plus LAMA] bronchodilator therapy for COPD patients who need or prefer nebulized treatment.
Data showed that both doses of AERO-007 led to significant improvements in lung function compared with the placebo. The average FEV1 over a full day was 251 mL higher with the low dose and 262 mL higher with the high dose than with the placebo. Maximum FEV1 improvement was 311 mL for the lower dose and 302 mL for the higher dose relative to the placebo.
“Nebulized AERO-007 demonstrated rapid, clinically meaningful bronchodilation that was sustained over 24 hours, supporting the potential of a once-daily nebulized [LABA plus LAMA] fixed-dose combination approach for patients who may not receive the full benefit of handheld inhaler-based treatment,” Singh said.
Blood levels of both drugs in AERO-007 were similar to or lower than those reported with Utibron Neohaler, a COPD-approved dry powder inhaler containing indacaterol and glycopyrrolate.
Both doses of AERO-007 were well tolerated. Most adverse events were mild, and no patient discontinued treatment because of them.
“These data strengthen our confidence in AERO-007 as a potential first-line maintenance, once-daily [LABA plus LAMA] bronchodilator therapy for COPD patients who need or prefer nebulized treatment,” Tutuncu said. “I am grateful to the patients, investigators, advisors, and AeroRx team who made this study possible, and we look forward to advancing the program into the next stage of clinical development.”
