BLU - BELLUS details late-stage plans for cough candidate after FDA meeting

• Following an End-of-Phase 2 with the FDA, Canadian biotech BELLUS Health ( NASDAQ: BLU ) announced plans to conduct two pivotal trials as part of its Phase 3 development for lead candidate BLU-5937 in refractory chronic cough (“RCC”).
• The CALM-1 and CALM-2 studies will be designed to evaluate the efficacy, safety and tolerability of BLU-5937 in nearly 675 adult patients.
• The company plans to enroll the first patient in 4Q 2022 for two placebo-controlled studies which will run parallelly testing 25 mg BID, 50 mg BID doses of BLU-5937.
• The primary endpoints of CALM-1 and CALM-2 are 24H cough frequency measured at 12-weeks and 24-weeks, respectively. Topline data from CALM-1 are expected in 2H 2024.
• Read: Bellus ( BLU ) shares climbed in December after the company announced favorable mid-stage data for BLU-5937 in RCC.

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