Benzinga | Dec 8, 2020 07:13AM EST

BELLUS Health Announces First Patient Dosed In Phase 2b SOOTHE Trial Of BLU-5937 For Treatment Of Refractory Chronic Cough

Interim analysis expected in mid-2021, with topline results expected in Q4 2021

BELLUS Health Inc. (NASDAQ:BLU, TSX:BLU) ("BELLUS Health" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders, today announced that the first patient has been dosed in the Phase 2b SOOTHE trial of BLU-5937, the Company's highly selective P2X3 antagonist, in patients with refractory chronic cough.

"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," said Dr. Cathy Bonuccelli, Chief Medical Officer at BELLUS Health. "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. We look forward to conducting the trial and reporting results in 2021."

"Globally, millions of individuals seek therapy for their debilitating refractory chronic cough each year, and without an approved treatment, the condition remains a challenge for both patients and physicians," said Dr. Jaclyn Smith, Professor of Respiratory Medicine at the University of Manchester in the United Kingdom, an Honorary Consultant at the University Hospital of South Manchester NHS Foundation Trust and Chair of BELLUS Health's Clinical Advisory Board. "Building on the results reported from multiple clinical trials, including BELLUS Health's Phase 2 RELIEF trial, the P2X3 class is a promising approach for patients. I look forward to continuing to study BLU-5937's potential in treating chronic cough, in hopes of filling this unmet need."

The SOOTHE trial is a multicenter, randomized, double-blind, four-week, parallel arm, placebo-controlled Phase 2b trial evaluating three doses of BLU-5937 (12.5 mg, 50 mg and 200 mg BID) in 300 participants with refractory chronic cough. 240 participants with a baseline awake cough frequency of ?25 awake coughs per hour are expected to be randomized across four arms (1:1:1:1) evaluating the three active doses of BLU-5937 and placebo in the main study. Treatment arms will be stratified to balance the number of participants with baseline awake cough frequency ?45 coughs per hour across trial arms. The primary efficacy endpoint will be the placebo-adjusted change in the 24-hour cough frequency from baseline to day 28 collected with a cough recorder. An exploratory group of an additional 60 participants with a baseline awake cough frequency of ?10 and <25 coughs per hour are expected to be randomized across 2 arms (1:1) evaluating one active dose (200 mg BID) and placebo to further investigate the effect of BLU-5937 in patients with lower cough frequency.

An interim analysis is expected to be conducted once 50% of patients have completed the main study and is anticipated in mid-2021. Using a predefined probability of efficacy hurdle, results from the interim analysis may be used to initiate planning activities for Phase 3. Topline results are expected in the fourth quarter of 2021.

The trial is expected to enroll participants at approximately 120 sites, including 55 centers in the United States.