Insmed completes enrollment of adult patients in phase 3 ASPEN study of brensocatib in bronchiectasis

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Insmed Incorporated announced that adult patient enrollment is complete in its pivotal ASPEN study of brensocatib. 

ASPEN is a global, randomized, double-blind, placebo-controlled phase 3 study to assess the efficacy, safety and tolerability of brensocatib in patients ages 12 to 85 years with non-cystic fibrosis bronchiectasis. More than 1,700 adult patients have been enrolled and randomized (1:1:1) to receive brensocatib 10 mg, brensocatib 25 mg or placebo once daily for 52 weeks, followed by four weeks off treatment. The primary endpoint is the rate of pulmonary exacerbations over the 52-week treatment period. Insmed anticipates reporting topline data from adults in the ASPEN trial in the second quarter of 2024.

Brensocatib is a small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) being developed by Insmed for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases. DPP1 is an enzyme responsible for activating neutrophil serine proteases (NSPs), such as neutrophil elastase, in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting DPP1 and its activation of NSPs. Brensocatib is an investigational drug product that has not been approved for any indication in any jurisdiction.

"We are thrilled to have completed adult patient enrollment on time in the ASPEN study, a critical milestone in our efforts to develop a potentially life-transforming therapy for people living with bronchiectasis," said Martina Flammer, MD, MBA, Insmed chief medical officer. "ASPEN is the largest single phase 3 study ever conducted in bronchiectasis, a serious pulmonary disease that today has no approved treatments. We believe the pace of enrollment and enthusiasm of the treating community reflect the significant need for a therapy specifically developed for this disease." 

Bronchiectasis is a severe, chronic pulmonary disorder in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. The condition is marked by frequent pulmonary exacerbations requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath and repeated respiratory infections, which can worsen the underlying condition. Bronchiectasis affects approximately 340,000 to 520,000 patients in the U.S. 

The ASPEN study is being conducted at more than 460 sites in nearly 40 countries. The enrollment of adolescent patients ages 12 through <18 is ongoing and does not have an impact on planned submission timelines with regulatory authorities. More information on the ASPEN study is available at clinicaltrials.gov (NCT04594369).

Insmed is also advancing the development of brensocatib in additional neutrophil-driven inflammatory diseases with significant health burdens and unmet treatment needs.





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