Global biopharmaceutical company Insmed Inc. (INSM:NASDAQ), which is focused on treatment of serious and rare diseases, today announced positive top-line results from its Phase 2 WILLOW study evaluating the safety and efficacy of INS1007, an oral, selective, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), in adults with non-cystic fibrosis bronchiectasis (NCFBE).
The company reported that in the WILLOW study, INS1007 achieved its primary endpoint of time to first pulmonary exacerbation and in addition, met a key secondary endpoint, a reduction in the frequency of pulmonary exacerbations. The firm indicated that INS1007 was also generally well-tolerated in the study.
Lead study investigator James Chalmers, MBChB, Ph.D., professor and consultant respiratory physician at the School of Medicine, University of Dundee, UK, commented, "These results are incredibly encouraging and highlight the potentially important role INS1007 may play in the management of bronchiectasis...many bronchiectasis patients suffer from persistent symptoms and frequent exacerbations with no pharmaceutical therapies available that are approved to help them manage this disease. There is an urgent need for approved, effective therapies that can break the vicious cycle of inflammation, lung damage, and infection for these patients."
The company's Chief Medical Officer Martina Flammer, M.D., MBA, remarked, "This molecule represents a novel, potentially first-in-class mechanism that utilizes an anti-inflammatory approach to treat the debilitating cycle of inflammation, infection, and lung damage associated with NCFBE...Importantly, in addition to achieving the primary and a key secondary endpoint, we saw significant reductions in sputum neutrophil elastase, an important biomarker that reflects the mechanism of action of INS1007. These data provide a strong rationale for continued development in this disease and potentially other neutrophil-driven inflammatory conditions. We look forward to further analyzing the data and discussing next steps with regulatory authorities."
Insmed's Chairman and CEO Will Lewis added, "The entire Insmed team is elated by the positive results observed in this study. This is a day of incredible promise for the hundreds of thousands of patients around the world who currently suffer from NCFBE. We believe these results further validate both our business and clinical development capabilities...With INS1007, Insmed has a unique and significant opportunity with a potential first-in-class therapy for NCFBE. There are currently no approved therapies specifically targeting this severe and chronic pulmonary disease in the U.S., Europe, or Japan."
The company explained that NCFBE is a severe, chronic pulmonary disorder that affects approximately 340,000 to 520,000 patients in U.S. In NCFBE, a condition marked by frequent pulmonary exacerbations requiring antibiotic therapy and often hospitalizations, the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage.
Insmed is a global biopharmaceutical company headquartered in Bridgewater, N.J., that specializes in the treatment of serious and rare diseases. In addition to INS1007 for use in the treatment of NCFBE, the firm noted that "its first commercial product, ARIKAYCE® (amikacin liposome inhalation suspension), is the first and only therapy approved in the U.S. for the treatment of refractory Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen for adult patients with limited or no alternative treatment options."
Insmed started off the days with a market capitalization of around $1.8 billion with approximately 89.34 million shares outstanding and a short interest of about 14.50%. INSM shares opened more than 45% higher today at $30.085 (+$9.545, +46.47%) over Friday's $20.54 closing price. The stock has traded today between $27.02 and $30.44 per share today and is currently trading at $29.18 (+$8.65, +42.04%).
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