Clinical Data Summary of Topline Results: Phase 2b SOOTHE Trial in Refractory Chronic CoughEfficacy Results: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 (p ≤ 0.005) at day 28. The 12.5 mg BID dose demonstrated a statistical trend with 21% reduction in placebo-adjusted 24-hour cough frequency (p=0.098) with a dose response observed between the 12.5 mg and 50 mg BID doses.SOOTHE Primary Efficacy EndpointDosePlacebo-adjusted change in
24-hour cough frequency at
day 28p-value12.5 mg BID-21.1%p=0.09850 mg BID-34.4%p=0.003200 mg BID-34.2%p=0.005Safety and Tolerability Results: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. Taste-related side effects were infrequent at all dose levels with taste alteration observed in 4.8%, 6.5% and 4.8% of participants at 12.5 mg BID, 50 mg BID and 200 mg BID, respectively. No participant reported complete or partial taste loss and there were no discontinuations due to taste-related adverse events.The treatment emergent adverse event profile was comparable to placebo. There were no treatment emergent serious adverse events reported in the trial.