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BELLUS Health Initiates Phase 1 Clinical Study for its Chronic Cough Drug Candidate, BLU-5937
BELLUS Health Initiates Phase 1 Clinical Study for its Chronic Cough Drug Candidate, BLU-5...
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[{"type":"text","content":"\n\n\n\nBELLUS Health Initiates Phase 1 Clinical Study for its Chronic Cough Drug Candidate, BLU-5937\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, July 9, 2018\n\n\n\n- Study Results Expected in the Fourth Quarter of 2018 -\n\n\n\nLAVAL, QC, July 9, 2018 /CNW/ - BELLUS Health Inc. (TSX: BLU) (\"BELLUS Health\" or the \"Company\"), a biopharmaceutical development company advancing novel therapeutics for conditions with high unmet medical need, today announced the initiation of healthy subjects dosing in a Phase 1 clinical study for BLU-5937, its lead drug candidate for the treatment of chronic cough. Preclinical studies demonstrated that BLU-5937 is a highly selective P2X3 antagonist exhibiting a potent anti-tussive effect without affecting taste perception, with an excellent safety profile.\n\nThe main objectives of the Phase 1 clinical study are to assess the safety, tolerability (including taste perception) and pharmacokinetic profile of BLU-5937 in healthy subjects. This is a randomized, double-blind, placebo-controlled study of orally administered BLU-5937 in up to 90 healthy adult subjects.\n\n\"We are excited to begin the first-in-human study of our lead drug candidate BLU-5937,\" said Roberto Bellini, president and CEO of BELLUS Health. \"We expect top-line Phase 1 data in the fourth quarter of 2018, where positive results would solidify BLU-5937's potential as a best in class P2X3 antagonist for chronic cough.\"\n\nThe study will be divided in two parts:\n\nPart 1: A single-ascending dose (\"SAD\") study will be conducted in up to 60 healthy subjects. Subjects will be randomized into up to 6 cohorts of 10 subjects (8 BLU-5937: 2 placebo).\n\nPart 2: A multiple-ascending dose (\"MAD\") study will be conducted in up to 30 healthy subjects. Subjects will be randomized into up to 3 cohorts of 10 subjects (8 BLU-5937: 2 placebo). Each subject will receive daily oral administrations of the assigned treatment for 7 consecutive days. The dose regimen for the MAD study will be established based on the SAD s...