BELLUS Health Announces FDA End-of-Phase 2 Meeting For Refractory Chronic Cough Program

BELLUS Health Inc BLU announced an End-of-Phase 2 meeting with the FDA and the details of the CALM Phase 3 program for BLU-5937 for refractory chronic cough.
Based on the FDA's feedback, the CALM Phase 3 program will include two pivotal trials, CALM-1, and CALM-2, each evaluating the efficacy, safety, and tolerability of BLU-5937 in approximately 675 adults.
CALM-1 and CALM-2 will evaluate 25 mg, 50 mg, and placebo treatment arms. The primary endpoint of 24-hour cough frequency will be measured at 12 weeks for CALM-1 and 24 weeks for CALM-2.
Related: BELLUS Health Stock Surges After Positive Data From Refractory Chronic Cough Trial.
Key secondary efficacy endpoints include Cough Severity.
The CALM Phase 3 trials will also enroll participants with baseline 24-hour cough frequency <20 coughs/hour. CALM-1 will have a 40-week randomized extension period and an additional 24-week open-label extension. CALM-2 will have a 28-week open-label extension.
The trials are planned to run in parallel, and the Phase 3 CALM program is expected to enroll its first patient in Q4 of 2022. Topline data from CALM-1 are expected in 2H of 2024.
Price Action: BLU shares closed at $9.65 on Monday.