AirNexis AN01 COPD Study Meets Primary Endpoint in China
AirNexis Therapeutics announces AN01, a dual PDE3/4 inhibitor DPI, met its primary endpoint in a Phase 2b COPD study conducted in China by Haisco, showing significant lung function improvements.
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- Phase 2b dose ranging data presented at ERS show both doses of AN01 delivered significant and clinically relevant improvements in lung function versus placebo at Week 4
- Trial comprised of broad COPD population, including participants on background single or dual bronchodilator therapy
- AN01 was well tolerated with no treatment-related adverse events reported in the 0.75 mg dose group, the dose under investigation in the Phase 3 program
- AirNexis has completed its Phase 1 multiple ascending dose (MAD) study in Australia and is preparing to initiate its Phase 2 program in 2027
REDWOOD CITY, Calif., Sept. 08, 2026 (GLOBE NEWSWIRE) — AirNexis Therapeutics, Inc. (“AirNexis”), a clinical-stage biotech company developing therapeutics for pulmonary diseases, today announced results from a Phase 2b study of AN01, a dual PDE3/4 inhibitor DPI. The study, HSK39004-T1-202, was conducted in China by AirNexis’ partner Haisco Pharmaceutical Group (“Haisco”). The Phase 2b study enrolled patients with chronic obstructive pulmonary disease (COPD) receiving background therapy of single or dual bronchodilator maintenance therapy who remained symptomatic despite such treatment. Data were presented earlier today at the 2026 European Respiratory Society (ERS) Congress in Barcelona, Spain. The ePoster will be available on the conference’s website. AirNexis licensed AN01 (HSK39004 in China) from Haisco, which is developing the asset for the Greater China market; AirNexis holds development rights outside China.
“We are pleased to share safety and efficacy data from the Phase 2b study of AN01 DPI in COPD patients for the first time,” said Maria Fardis, Ph.D., MBA, CEO of AirNexis Therapeutics. “The study met its primary endpoint, with AN01 significantly improving lung function versus placebo in patients on background standard-of-care therapy, including those already on dual bronchodilator therapy. No treatment-related adverse events were reported in the 0.75 mg dose, the dose under investigation in the Phase 3 program. These results reinforce AN01 DPI’s potential as a convenient, easy-to-administer treatment option for a broader COPD patient population.”
AN01 Clinical Program Update
AN01 (HSK39004 in China) has been administered to more than 600 subjects across Haisco’s and AirNexis’ clinical programs. AirNexis has completed AN-HV-1001, a Phase 1 MAD study in healthy volunteers in Australia and the Company is preparing to initiate its Phase 2 program in 2027. Separately, Haisco’s Phase 3 program for AN01 is underway in China, including an ongoing Phase 3 DPI study (NCT07583849).
Overview of HSK39004-T1-202 data presented at ERS
Data from the poster entitled “A Dose-Ranging Study of the Novel PDE3/4 Inhibitor HSK39004 in Patients with COPD Receiving Maintenance Single or Dual Bronchodilators” were presented earlier today at ERS, and data are summarized below.
- The Phase 2b study HSK39004-T1-202 (NCT07108699) randomized 195 patients, 90 on a single bronchodilator therapy and 105 on dual bronchodilator therapy, in a 1:1:1 ratio to AN01 0.75 mg, AN01 1.5 mg, or placebo for four weeks.
- The primary endpoint was change from baseline in FEV₁ area under the curve from 0 to 12 hours post-dose (ΔFEV₁ AUC₀₋₁₂h) at Week 4.
- Both doses significantly improved ΔFEV₁ AUC₀₋₁₂h versus placebo, with treatment differences of 116 mL for the 0.75 mg dose and 127 mL for the 1.5 mg dose.
- In a subgroup analysis, both doses showed significant improvements in patients on single bronchodilator therapy (164 mL and 189 mL) and, notably, in patients already on dual bronchodilator therapy (74 mL and 75 mL), supporting AN01’s potential for patients not adequately controlled on existing COPD regimens.
- No treatment-related adverse events occurred in the 0.75 mg group. The treatment-related adverse event rate in the 1.5 mg group was 6.1%, compared with 7.9% in the placebo group.
About AN01
AN01 is a novel dual PDE3/4 inhibitor being developed for chronic obstructive pulmonary disease (COPD), a progressive inflammatory lung disease that remains inadequately controlled in many patients despite available therapies. PDE3/4 is a clinically validated target for COPD with an approved therapy demonstrating meaningful benefit to patients with COPD. Delivered directly to the lungs via a dry powder inhaler, AN01 is engineered to maximize pulmonary exposure while minimizing systemic drug levels. AN01 as a DPI offers convenience of administration to patients fitting into the patient’s daily life. AirNexis licensed AN01 (also known as HSK39004) from Haisco Pharmaceutical Group, which is developing the asset for the Greater China market. AN01 (HSK39004 in China) has been administered to more than 600 subjects across Haisco’s and AirNexis’ clinical programs. AirNexis holds development rights outside China and is advancing the program towards registration.
About AirNexis Therapeutics
AirNexis Therapeutics is a clinical-stage biotech company developing novel therapeutic drugs for the treatment of pulmonary diseases. The company’s lead candidate, AN01, is a dual PDE3/4 inhibitor that exerts synergistic effects through a dual mechanism of action that promotes bronchodilation and reduces the release of inflammatory factors. For more information, please visit www.Airnexis.com.
Contacts
Investor Contact:
Juli P. Miller, PhD
jmiller@lifesciadvisors.com
