Insmed Completes Enrollment of Adult Patients in Phase 3 ASPEN Study of Brensocatib in Bronchiectasis
Insmed Incorporated, a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, announced that adult patient enrollment is complete as of today in its pivotal ASPEN study of brensocatib in Bronchiectasis.
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 4 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.
“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, M.D., MBA, Chief Medical Officer of Insmed. “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. We are grateful to the patients, their families, and the clinical trial investigators for their support and commitment to advancing this important work.”
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.
Brensocatib has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration as well as Priority Medicines (PRIME) designation from the European Medicines Agency for patients with bronchiectasis. 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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