BELLUS Health Announces Positive Interim Analysis from the Phase 2b SOOTHE Trial of BLU-5937 in Refractory Chronic Cough
7:45 am ET September 13, 2021 (BusinessWire) Print
--Data from interim analysis support accelerated planning for the Phase 3 program
--SOOTHE Phase 2b trial is on track to deliver topline results 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 refractory chronic cough and other hypersensitization-related disorders, today announced positive findings from a preplanned administrative interim analysis of the ongoing Phase 2b SOOTHE trial of BLU-5937, the Company's highly selective P2X3 antagonist, in patients with refractory chronic cough ("RCC").
An independent statistical team reported that the predefined stringent probability threshold for clinical efficacy was met for at least one dose of BLU-5937. The following observations of the interim data were made regarding key aspects of the BLU-5937 product profile:
- At least one dose of BLU-5937 met the stringent predefined probability threshold for a clinically meaningful reduction in placebo-adjusted 24-hour cough frequency;
- Limited taste-related adverse events were observed, consistent with previous BLU-5937 trials;
- No serious adverse events were reported.
"We believe the encouraging SOOTHE Phase 2b trial interim analysis will enable us to accelerate the planning for our Phase 3 program while awaiting SOOTHE final results," said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "With trial enrollment progressing as planned, we anticipate announcing topline data in the fourth quarter of 2021."
About SOOTHE
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 greater-than or equal to25 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 greater-than or equal to45 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 greater-than or equal to10 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. More information about the trial is available at www.clinicaltrials.gov: NCT04678206.
About the Interim Analysis
An independent statistical team conducted the preplanned interim analysis once half of the total participants in the main trial completed their treatment period. The interim analysis was performed for administrative purposes and has no impact on the design or future conduct of the SOOTHE trial. Trial participants will continue to be enrolled and followed to trial completion.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of RCC and other hypersensitization-related disorders. The Company's product candidate, BLU-5937, is being developed for the treatment of RCC and chronic pruritus associated with AD.
RCC is a cough lasting more than 8 weeks despite appropriate treatment for underlying condition(s). It is estimated that there are approximately 9 million patients in the United States suffering from RCC. RCC is associated with significant adverse physical, social, and psychosocial effects on health and quality of life. Currently, there is no specific therapy approved for RCC and treatment options are limited.
Chronic pruritus associated with AD is an irritating sensation that leads to scratching and persists for longer than 6 weeks in AD patients. It is estimated that up to 10% of adults in the United States suffer from AD - almost all report symptoms of pruritus with over 50% of patients attributing chronic pruritus as their most burdensome symptom. Despite currently available treatments targeting AD, there continues to be a lack of options specifically targeting the burden of pruritus in patients with AD.
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