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BELLUS Health Announces Clearance of U.S. IND for BLU-5937 Phase 2 Study in Chronic Cough Patients
BELLUS Health Announces Clearance of U.S. IND for BLU-5937 Phase 2 Study in Chronic Cough ...
About this update from Bluenergies Ltd.
[{"type":"text","content":"\n\n\n\nBELLUS Health Announces Clearance of U.S. IND for BLU-5937 Phase 2 Study in Chronic Cough Patients\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n.prntac{\nTEXT-ALIGN: CENTER\n}\n\n\n\n\n\n\n\nCanada NewsWire\nLAVAL, QC, April 3, 2019\n\n\n\n- Phase 2 Study for Potential Best-in-Class Therapeutic for Refractory Chronic Cough Patients Expected to Start in Mid-2019 -\n LAVAL, QC, April 3, 2019 /CNW/ - BELLUS Health Inc. (TSX: BLU) (\"BELLUS Health\" or the \"Company\"), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders, today announced that the U.S. Food and Drug Administration (\"FDA\") has accepted the Company's Investigational New Drug (\"IND\") application, thus clearing the start of its Phase 2 study for BLU-5937 in chronic cough patients in the United States.\n\"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.\"\nBELLUS 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.\nPhase 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 dosin...