The United States Food and Drug Administration (FDA) has granted United States-based Insmed Incorporated (Nasdaq:INSM) breakthrough therapy designation for its brensocatib (formerly known as INS1007) intended for the treatment of adult patients with non-cystic fibrosis bronchiectasis for reducing exacerbations, it was reported on Monday.
The product is a novel oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) presently being developed by the company for the treatment of bronchiectasis and other inflammatory diseases.
Brensocatib has received breakthrough therapy designation based on positive results from the global randomised, double-blind, placebo-controlled Phase two WILLOW study of brensocatib in adults with non-cystic fibrosis bronchiectasis. The company aims to start a phase three program for brensocatib in bronchiectasis in the second half of 2020.
Inogen secures FDA clearance for SIMEOX 200 Airway Clearance Device
Infex Therapeutics begins Phase IIa trial for RESP-X in NCFB patients
SalioGen Therapeutics names new chief medical officer
Destiny Pharma launches research on XF-73 for cystic fibrosis MRSA infections
Polarean Imaging enters into trade-in agreement with University of Kansas Medical Center
Sionna Therapeutics doses first healthy subject in SION-109 phase one clinical trial
Arcturus Therapeutics granted FDA Orphan Drug Designation for ARCT-032 to treat cystic fibrosis
SpliSense completes SPL84 first-in-human, Phase one clinical trial for cystic fibrosis treatment