Bellus completes patient enrollment in phase 2b SOOTHE trial of BLU-5937 for RCC and phase 2a BLUEPRINT trial of BLU-5937 to treat chronic pruritus associated with AD

Laval, QuebecSaturday, September 25, 2021, 18:00 Hrs  [IST]

Bellus Health, a clinical-stage biopharmaceutical company, announced that the company has completed patient enrollment in the phase 2b SOOTHE clinical trial of BLU-5937 in refractory chronic cough (RCC) and the phase 2a BLUEPRINT clinical trial of BLU-5937 in chronic pruritus associated with atopic dermatitis (AD). Topline results from both trials are expected in December 2021.

“Completion of enrollment in our SOOTHE trial marks an important milestone, underscoring the progress we have made advancing BLU-5937 for the treatment of RCC. As recently reported, we are encouraged by the positive outcome of our recent administrative interim analysis from the SOOTHE trial, and look forward to sharing topline results from both SOOTHE and our phase 2a BLUEPRINT trial in chronic pruritus in December 2021,” said Roberto Bellini, president and chief executive officer of Bellus Health. “Chronic cough and chronic pruritis negatively impact individuals’ quality of life, and each indication represents a significant unmet medical need. We are grateful to the patients and clinical investigators who are participating in our trials.”

Bellus Health previously announced on September 13, 2021 results from a planned administrative interim analysis of the phase 2b SOOTHE trial in RCC. An independent statistical team reported that a predefined stringent probability threshold for clinical efficacy was met for at least one and up to all three doses of BLU-5937 tested.

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 310 participants with RCC. A total of 249 participants with a baseline awake cough frequency of =25 awake coughs per hour were randomized across four arms (1:1:1:1) evaluating the three active doses of BLU-5937 and placebo in the main study. Treatment arms were stratified to balance the number of participants with baseline awake cough frequency =45 coughs per hour across trial arms.

The BLUEPRINT trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-design phase 2a trial evaluating the efficacy, safety and tolerability of BLU-5937 in 142 participants with moderate to severe chronic pruritus associated with mild to moderate AD. Participants were randomized into one of two treatment arms (1:1) and receive either 200 mg BID of BLU-5937 or placebo for a four-week treatment period. The primary efficacy endpoint is the change from baseline in weekly mean Worst Itch-Numeric Rating Scale (WI-NRS) score at week four.