Interim analysis met the threshold for a high probability of clinical efficacy
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
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
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. 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.
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