BELLUS Health Inc. (NASDAQ: BLU) stock surged by 1.19% at last close whereas the BLU stock price declines by 5.86% in the after-hours trading session. BELLUS Health is a clinical-stage pharmaceutical business focused on discovering new treatments for RCC and other hypersensitization-related diseases. BLU-5937 is a pharmaceutical candidate being developed by the company for the treatment of RCC and persistent pruritus associated with Alzheimer’s disease.
BLU stock’ Recent Past Development
BELLUS Health Inc. reported that enrolment in the Phase 2b SOOTHE clinical study of BLU-5937 in refractory chronic cough and the Phase 2a BLUEPRINT clinical study of BLU-5937 in chronic pruritus related to atopic dermatitis has been completed. Both trials’ topline findings are expected in December 2021.
The SOOTHE study is a 310-person, placebo-controlled Phase 2b trial assessing three dosages of BLU-5937 (12.5 mg, 50 mg, and 200 mg BID). In the primary research, 249 individuals with a baseline awake cough frequency of 25 coughs per hour were randomized into four groups (1:1:1:1) to test the three active BLU-5937 dosages and placebo. The number of patients having a baseline awake cough frequency of 45 coughs per hour was balanced between trial arms by stratifying the treatment arms. The placebo-adjusted change in 24-hour cough frequency from baseline to day 28 recorded using a cough recorder is the main effectiveness objective.
Roberto Bellini, President, and CEO of BELLUS Health stated,
The completion of enrolment in the SOOTHE study is a significant step forward in the development of BLU-5937 for the cure of RCC. They are pleased by the excellent results of their latest administrative intermediate analysis from the SOOTHE study, as they previously announced, and look forward to reporting topline data from both SOOTHE and their Phase 2a BLUEPRINT trial in chronic pruritus in December 2021.
BELLUS Health had earlier published the findings of a planned administrative intermediate review of the Phase 2b SOOTHE study in RCC on September 13, 2021. A specified rigorous probability criterion for clinical effectiveness was satisfied for at least one and up to all three dosages of BLU-5937 examined, according to an independent statistical team. In addition, the study found that there were few taste-related adverse events, which was consistent with prior BLU-5937 studies, and no major adverse events.