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Insmed Announces Positive Results from ASPEN Study of Brensocatib in Bronchiectasis Patients

Insmed Incorporated has reported positive topline results from the ASPEN study, a pivotal Phase III clinical trial evaluating the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis. The study achieved its primary endpoint, demonstrating that brensocatib significantly reduced the annualized rate of pulmonary exacerbations (PEs) compared to placebo.

The ASPEN study, which involved 1,680 adult patients and 41 adolescents across 391 sites in 35 countries, tested two dosages of brensocatib. Both dosages resulted in statistically significant and clinically meaningful reductions in the frequency of PEs. Additionally, brensocatib met several secondary endpoints with statistical significance, confirming its potential as a treatment for bronchiectasis.

Brensocatib, a dipeptidyl peptidase 1 (DPP1) inhibitor, represents a novel mechanism of action aimed at neutrophil-mediated diseases. The success of the ASPEN study validates DPP1 inhibition as a promising therapeutic strategy, potentially addressing a range of inflammatory conditions driven by neutrophils.

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Insmed plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for brensocatib in the fourth quarter of 2024, aiming for a U.S. launch in mid-2025, pending regulatory approval. This would mark the first approved treatment for bronchiectasis, offering hope to approximately 1 million patients in key regions. Subsequent launches in Europe and Japan are anticipated in the first half of 2026.

Brensocatib has already received Breakthrough Therapy Designation from the FDA and access to the Priority Medicines (PRIME) scheme by the European Medicines Agency for bronchiectasis patients. Detailed results from the ASPEN study will be presented at an upcoming medical meeting.

Beyond bronchiectasis, Insmed is exploring brensocatib’s potential in other neutrophil-driven inflammatory diseases. A Phase 2 study in patients with chronic rhinosinusitis without nasal polyps (CRSsNP) is underway, and a Phase 2 study in hidradenitis suppurativa (HS) is planned for the second half of 2024.

Novel Therapeutics