BELLUS Health (NASDAQ:BLU; TSX:BLU) dosed the first patient in its Phase 2b study evaluating BLU-5937 for the treatment of refractory chronic cough.
The study, called SOOTHE, will evaluate three doses of BLU-5937 in 300 patients, compared with placebo. The study’s primary efficacy endpoint is the placebo-adjusted change in the 24-hour cough frequency from baseline to day 28.
“We are thrilled to announce the initiation of our SOOTHE trial, an important milestone for the development of BLU-5937, as well as a promising step forward for the millions of chronic cough patients lacking an approved therapy,” Cathy Bonuccelli, M.D., BELLUS’ CMO, said in a statement.
“BLU-5937’s validated mechanism of action, along with the encouraging data generated from our previously completed Phase 2 RELIEF trial, suggest that this candidate has the potential to help meet this large unmet need, with the potential to avoid burdensome class-specific adverse effects,” she added.
The company expects to conduct an interim analysis in mid-2021, once 50% of patients have completed the study. Topline results are expected in the fourth quarter of 2021.
