FDA grants breakthrough therapy designation to brensocatib
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The FDA has granted breakthrough therapy designation to brensocatib for the treatment of non-cystic fibrosis bronchiectasis in adults, according to a press release from Insmed.
Brensocatib (Insmed) is a small molecule, oral, reversible inhibitor of dipeptidyl-peptidase I. Brensocatib may decrease the damaging effects of inflammatory diseases such as bronchiectasis by inhibiting dipeptidyl-peptidase I and its activation of neutrophil serine proteases, according to the release.
This breakthrough therapy designation will expedite development and review of brensocatib.
The breakthrough therapy designation is based on positive results from the global randomized, double-blind, placebo-controlled, phase 2 WILLOW study. WILLOW evaluated efficacy, safety, tolerability and pharmacokinetics of once-daily brensocatib for 24 weeks in adults with non-cystic fibrosis bronchiectasis. The study enrolled 256 adults at 116 sites. The primary efficacy endpoint was time to first pulmonary exacerbation over 24 weeks among patients assigned 10 mg or 25 mg brensocatib compared with placebo, according to the release.
“We are very pleased that the FDA has granted breakthrough therapy designation to brensocatib for treating patients with [non-cystic fibrosis bronchiectasis], recognizing the strength of data from our phase 2 WILLOW study and the potential for brensocatib to offer a novel, first-in-class treatment approach to bronchiectasis,” Martina Flammer, MD, MBA, chief medical officer of Insmed, said in the release. “There are currently no approved therapies specifically targeting this severe and chronic pulmonary disease in the United States, Europe or Japan. We look forward to continuing to work with the FDA as we advance the development of brensocatib to address this urgent medical need.”
Full results from the WILLOW study are slated for presentation during a virtual clinical trials session hosted by the American Thoracic Society on June 24. Healio will report these results.
Insmed also announced plans to begin a phase 3 program for brensocatib in late 2020.