Insmed Reports Positive Topline Results from ASPEN Study of Brensocatib in Bronchiectasis Patients

Insmed Incorporated, a biopharmaceutical firm, has announced promising results from the ASPEN study, a Phase 3 clinical trial examining the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis. The study, which included a global cohort, demonstrated that brensocatib significantly reduced the frequency of pulmonary exacerbations (PEs) compared to a placebo for both dosage strengths. Multiple secondary endpoints were also met with statistical significance, and the drug was well-tolerated overall.

The trial was a global, randomized, double-blind, placebo-controlled study that enrolled a diverse patient population spanning 35 countries, excluding sites in Ukraine and those that did not enroll patients. Over 1,700 adults and adolescents participated in the trial, receiving either 10 mg or 25 mg of brensocatib or a placebo daily for 52 weeks, followed by a 4-week period off the medication. The primary analysis included data from 1,680 adults and 41 adolescents.

Following these positive results, Insmed has announced plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) by the end of 2024, with hopes to launch brensocatib in the U.S. by mid-2025, pending regulatory approval. The company also plans subsequent launches in Europe and Japan by early 2026. If approved, brensocatib would be the first treatment specifically for bronchiectasis and the first dipeptidyl peptidase 1 (DPP1) inhibitor, offering a novel approach to managing neutrophil-mediated diseases.

James Chalmers, the lead investigator of the study, expressed optimism about the impact of brensocatib on bronchiectasis patients, citing the drug's significant and clinically meaningful effects. Martina Flammer, Insmed’s Chief Medical Officer, emphasized the potential of DPP1 inhibition as a new therapeutic mechanism that could address various neutrophil-driven inflammatory diseases.

The study revealed that brensocatib was generally well-tolerated. The most common treatment-emergent adverse events (TEAEs) included COVID-19, nasopharyngitis, cough, and headache. These occurred with similar frequency across both the brensocatib and placebo groups.

Insmed is also exploring other applications for brensocatib. The company is conducting a Phase 2 study in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) and plans to initiate another Phase 2 study in hidradenitis suppurativa (HS) later in 2024.

The ASPEN study’s results have further validated DPP1 inhibition as a promising therapeutic mechanism. Insmed's commitment to rapidly advancing toward regulatory filings underscores its dedication to addressing unmet medical needs in bronchiectasis and other inflammatory diseases.

Insmed will host a commercial webinar on June 4, 2024, to discuss the market potential for its advanced programs, including brensocatib. The company has also scheduled an investor call on May 28 to delve into the ASPEN study results.

In summary, Insmed’s ASPEN study has yielded positive outcomes, demonstrating brensocatib’s potential as a novel treatment for bronchiectasis. With plans in place for regulatory submissions and future studies in other inflammatory conditions, Insmed is poised to make significant strides in improving patient care for those suffering from serious and rare diseases.