Insmed enrolls adults in brensocatib phase 3 trial in bronchiectasis

Insmed Incorporated said that it has wrapped up enrollment of adult patients in the ASPEN phase 3 clinical trial of brensocatib in bronchiectasis.

According to the New Jersey-based biopharma company, ASPEN is a global randomized, double-blind, placebo-controlled study that aims to examine the safety, efficacy, as well as tolerability of brensocatib in patients aged between 12 and 85 years who suffer from non-cystic fibrosis bronchiectasis.

A total of over 1,700 adult patients have been registered and randomly assigned (1:1:1) in the ASPEN clinical trial to be treated with brensocatib, 10mg or brensocatib 25mg, or placebo daily for 52 weeks, and then followed by four weeks off treatment.

The primary endpoint of the late-stage trial is the frequency of exacerbations of the pulmonary system over the 52-week treatment period.

Insmed expects to report topline data from adults participating in the ASPEN clinical trial in Q2 2024.

Martina Flammer — Insmed Chief Medical Officer said: “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.

“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.”

This ASPEN clinical study is carried out at over 460 sites across nearly 40 countries. The recruitment of adolescents between the ages of 12 and 18 is ongoing and doesn’t have any effect on the scheduled submission deadlines with regulatory authorities, said Insmed.

Brensocatib has received breakthrough therapy designation from the US Food and Drug Administration and Priority Medical Equipment (PRIME) designation from European Medicines Agency (EMA) for patients suffering from bronchiectasis.

Insmed is also working to advance the small molecule, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) for additional inflammatory diseases triggered by neutrophils that have substantial health burdens and unmet treatment demands.