Topline results expected in Q4 2021

LAVAL, Canada I December 14, 2020 I BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (“BELLUS Health” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders, today announced that the first patient has been dosed in the Phase 2 BLUEPRINT trial of BLU-5937, the Company’s highly selective P2X3 antagonist, in patients with chronic pruritus associated with atopic dermatitis.

“The initiation of the BLUEPRINT trial marks a key step forward in evaluating BLU-5937’s potential broad applicability across chronic disorders triggered by hypersensitization,” commented Roberto Bellini, President and CEO of BELLUS Health. “Chronic pruritus, the second indication we are pursuing with our P2X3 antagonist BLU-5937, is the hallmark and one of the most burdensome symptoms of atopic dermatitis, significantly affecting an individual’s quality of life. We believe BLU-5937 has the potential to significantly alleviate an atopic dermatitis patient’s urge to scratch and look forward to reporting topline data from this trial in the fourth quarter of 2021.”

The BLUEPRINT study is a multicenter, randomized, double-blind, placebo-controlled, parallel-design Phase 2 trial evaluating the efficacy, safety and tolerability of BLU-5937 in approximately 128 adult patients with moderate to severe chronic pruritus associated with mild to moderate atopic dermatitis. Patients will be randomized into one of two treatment arms (1:1) and will receive either 200 mg BID of BLU-5937 or placebo for a four-week treatment period. The primary efficacy endpoint will be the change from baseline in weekly mean Worst Itch-Numeric Rating Scale (WI-NRS) score at week four. A key secondary endpoint will be a responder-rate analysis of at least a four-point WI-NRS improvement from baseline at week four.

The study will be performed at approximately 29 study centers located in Canada and the United States.

About BLU-5937

BLU-5937, a highly selective P2X3 antagonist – (>1500 fold) – is in development for chronic cough, chronic pruritus and other hypersensitization-related disorders.

The P2X3 receptor in the cough reflex pathway, which is implicated in chronic cough, is a rational target for treating chronic cough, and it has been evaluated in multiple clinical trials with different P2X3 antagonists. The Company believes that its highly selective P2X3 antagonist has the potential to reduce coughing in patients with refractory chronic cough while limiting taste disturbance adverse events.

In addition to chronic cough and chronic pruritus, BLU-5937 may also have broad applicability across other afferent hypersensitization-related disorders, enabling the Company to consider developing a pipeline of therapies using its P2X3 platform. BELLUS Health is exploring how P2X3 activation can contribute to irritation and pain, and whether inhibition of P2X3 receptors can help treat these afferent hypersensitization-related disorders.

About BELLUS Health (www.bellushealth.com)

BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of chronic cough and other hypersensitization-related disorders. The Company’s product candidate, BLU-5937, is being developed for the treatment of chronic cough and chronic pruritus.

Chronic cough, the lead indication for BLU-5937, is a cough lasting more than eight weeks and is associated with significant adverse physical, social and psychosocial effects on health and quality of life. It is estimated that approximately 26 million adults in the United States suffer from chronic cough with approximately 3 million having refractory chronic cough lasting for more than a year and approximately 6 million having refractory chronic cough lasting more than 8 weeks and under one year. There is no specific therapy approved for refractory chronic cough and current treatment options are limited.

Chronic pruritus, the second indication for BLU-5937, is commonly known as chronic itch and is an irritating sensation that leads to scratching and persists for longer than six weeks, which can be debilitating and can significantly impact quality of life. It is a hallmark of many inflammatory skin diseases, including AD. It is estimated that AD afflicts approximately 5% of adults in the United States. Despite currently available treatments targeting AD, there continues to be a lack of options targeting the burden of pruritus in AD patients.

SOURC: BELLUS Health