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BELLUS Health Receives Clearance of U.S. IND for BLU-5937 Phase 2 Study in Chronic Cough Patients
Apr. 03, 2019 08:59AM PST
Biotech InvestingBELLUS Health ((TSX:BLU) has announced that the US Food and Drug Administration (FDA) has accepted Bellus’ investigational new drug (IND) application and advancing its Phase 2 study for BLU-5937 in chronic cough patients in the US. As quoted in the press release: We’re very pleased that our first interactions with U.S. regulators have been positive …
BELLUS Health ((TSX:BLU) has announced that the US Food and Drug Administration (FDA) has accepted Bellus’ investigational new drug (IND) application and advancing its Phase 2 study for BLU-5937 in chronic cough patients in the US.
As quoted in the press release:
We’re very pleased that our first interactions with U.S. regulators have been positive and look forward to treating chronic cough patients with BLU-5937 shortly,” commented Roberto Bellini, President and CEO of BELLUS Health. “Unlike other P2X3 antagonists, BLU-5937 is highly-selective, meaning that it can potentially reduce coughing, with very little to no effect on taste.”
BELLUS Health expects to initiate the clinical Phase 2 study for BLU-5937 in chronic cough patients in mid-2019, with top-line results anticipated in mid-2020. This will be a randomized, double-blind, placebo-controlled crossover, and dose-escalation study to assess the efficacy, safety, and tolerability of BLU-5937, in addition to helping confirm the optimal dose regimen. Four doses of BLU-5937 will be tested: 25, 50, 100, and 200 mg twice-daily. The study is expected to be conducted in approximately 50 patients with refractory chronic cough at 10 to 12 clinical sites in the United States and the United Kingdom.
Phase 1 data reported in November 2018 showed that BLU-5937 is safe and well-tolerated, with very limited taste alterations at the anticipated therapeutic doses and a pharmacokinetic profile supporting twice-daily dosing.