Proactive Investors - Insmed Incorporated (NASDAQ:INSM) shares more than doubled after the company released positive results from its late-stage study of its experimental therapy brensocatib for a lung condition.
The company said patients in the study with non-cystic fibrosis bronchiectasis who were dosed with brensocatib saw statistically significant reductions in the annualized rate of pulmonary exacerbations compared to placebo.
Based on the trial results, Insmed intends to file a New Drug Application with the US Food and Drug Administration (FDA) for brensocatib in patients with bronchiectasis in the fourth quarter of 2024.
Pending regulatory approvals, the company anticipates a U.S. launch of brensocatib in mid-2025 to be followed by launches in Europe and Japan in the first half of 2026.
Insmed highlighted that, if approved, brensocatib would be the first approved treatment for patients with bronchiectasis, a condition where the airways become widened leading to a build-up of excess mucus which can make the lungs more vulnerable to infection.
“As a DPP1 inhibitor, brensocatib would be the first treatment in its class and could offer a completely new approach to managing this difficult-to-treat patient population, heralding a new era in clinical management of bronchiectasis,” lead study investigator Dr James Chalmers commented.
Insmed chief medical officer Martina Flammer added: “These findings not only underscore our belief that brensocatib has the potential to transform the treatment landscape for bronchiectasis, but they also further validate DPP1 inhibition as a mechanism that may hold promise in other neutrophil-mediated diseases.”
“We now look forward to further analyzing the data while rapidly advancing toward regulatory filings in our key regions, where we believe approximately 1 million bronchiectasis patients may benefit from an approved treatment."
Shares of Insmed added 112.6% at about $47 in the early afternoon on Tuesday.