BELLUS Announces Positive Topline Results From Phase 2b SOOTHE Trial Of BLU-5937

(RTTNews) - BELLUS Health Inc. (BLU, BLU.TO), on Monday, announced that the 50 mg and 200 mg BID doses of BLU-5937 in its Phase 2b SOOTHE trial for the treatment of RCC achieved statistical significance on the primary endpoint with 34% placebo-adjusted reduction in 24-hour cough frequency observed at day 28. BLU-5937 was generally well-tolerated, with low rates of taste-related adverse events reported at all doses.

The SOOTHE trial, which enrolled 249 participants with a baseline awake cough frequency of = 25 per hour, demonstrated a clinically meaningful and statistically significant placebo-adjusted reduction in 24-hour cough frequency of 34% at the 50 mg and 200 mg BID dose levels of BLU-5937 at day 28. The 12.5 mg BID dose showed a statistical trend with 21% reduction in placebo-adjusted 24-hour cough frequency with a dose response observed between the 12.5 mg and 50 mg BID doses.

The company noted that BLU-5937's safety and tolerability data were consistent with previous trials, including the Phase 2a RELIEF trial. BLU-5937 was well-tolerated with low impact on taste perception.

Further, the company intends to request an End of Phase 2 meeting with the FDA that is expected to take place in the second quarter of 2022 to discuss the Phase 3 program which is expected to start in the second half of 2022.