- Phase 2 Study for Potential Best-in-Class Therapeutic for Refractory Chronic Cough Patients Expected to Start in Mid-2019 -
LAVAL, QC, April 3, 2019 /CNW/ - BELLUS Health Inc. (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 U.S. Food and Drug Administration ("FDA") has accepted the Company's Investigational New Drug ("IND") application, thus clearing the start of its Phase 2 study for BLU-5937 in chronic cough patients in the United States.
"We're very pleased that our first interactions with U.S. regulators have been positive and look forward to treating chronic cough patients with BLU-5937 shortly," commented Roberto Bellini, President and CEO of BELLUS Health. "Unlike other P2X3 antagonists, BLU-5937 is highly-selective, meaning that it can potentially reduce coughing, with very little to no effect on taste."
BELLUS Health expects to initiate the clinical Phase 2 study for BLU-5937 in chronic cough patients in mid-2019, with top-line results anticipated in mid-2020. This will be a randomized, double-blind, placebo-controlled crossover, and dose-escalation study to assess the efficacy, safety, and tolerability of BLU-5937, in addition to helping confirm the optimal dose regimen. Four doses of BLU-5937 will be tested: 25, 50, 100, and 200 mg twice-daily. The study is expected to be conducted in approximately 50 patients with refractory chronic cough at 10 to 12 clinical sites in the United States and the United Kingdom.
Phase 1 data reported in November 2018 showed that BLU-5937 is safe and well-tolerated, with very limited taste alterations at the anticipated therapeutic doses and a pharmacokinetic profile supporting twice-daily dosing.
BLU-5937, a highly selective P2X3 antagonist, has the potential to be a best-in-class therapeutic for refractory chronic cough patients. BLU-5937 has been shown to be highly selective (>1500 fold) for human P2X3 receptors versus P2X2/3 receptors.
The P2X3 receptor in the cough reflex pathway is a rational target for treating refractory chronic cough, and it has been validated in animal and human studies. With a modestly-selective P2X3 antagonist therapy for chronic cough, an adverse effect on taste perception is a well-known and widely-documented tolerability issue. The Company believes that a highly selective P2X3 antagonist can reduce coughing in patients with refractory chronic cough, while maintaining taste function by not inhibiting P2X2/3 receptors.
In addition to chronic cough, BLU-5937 may potentially have clinical benefit in other afferent hypersensitization-related disorders, such as visceral pain, hypertension, and migraine, among others. BELLUS Health is currently conducting preclinical studies in additional undisclosed indications.
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 lead drug candidate, BLU-5937, is being developed for the treatment of chronic cough.
Chronic cough 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 more than 2.6 million having unexplained or refractory chronic cough lasting for more than a year. There are limited treatment options for refractory chronic cough including no currently approved therapeutics.
Certain statements contained in this news release, other than statements of fact that are independently verifiable at the date hereof, may constitute "forward-looking statements" within the meaning of Canadian securities legislation and regulations. Such statements, based as they are on the current expectations of management, inherently involve numerous important risks, uncertainties and assumptions, known and unknown, many of which are beyond BELLUS Health Inc.'s control. Such risks factors include but are not limited to: the ability to expand and develop its project pipeline, the ability to obtain financing, the impact of general economic conditions, general conditions in the pharmaceutical industry, changes in the regulatory environment in the jurisdictions in which BELLUS Health Inc. does business, stock market volatility, fluctuations in costs, changes to the competitive environment due to consolidation, achievement of forecasted burn rate, potential payments/outcomes in relation to indemnity agreements and contingent value rights, achievement of forecasted pre-clinical and clinical trial milestones and that actual results may vary once the final and quality-controlled verification of data and analyses has been completed. In addition, the length of BELLUS Health Inc.'s drug candidates' development process, their market size and commercial value, as well as the sharing of proceeds between BELLUS Health Inc. and its potential partners from potential future revenues, if any, are dependent upon a number of factors. Consequently, actual future results and events may differ materially from the anticipated results and events expressed in the forward-looking statements. BELLUS Health Inc. believes that expectations represented by forward-looking statements are reasonable, yet there can be no assurance that such expectations will prove to be correct. The reader should not place undue reliance, if any, on any forward-looking statements included in this news release. These forward-looking statements speak only as of the date made, and BELLUS Health Inc. is under no obligation and disavows any intention to update publicly or revise such statements as a result of any new information, future event, circumstances or otherwise, unless required by applicable legislation or regulation. Please see BELLUS Health Inc.'s public filings with the Canadian securities regulatory authorities, including the Annual Information Form, for further risk factors that might affect BELLUS Health Inc. and its business.
SOURCE BELLUS Health Inc.
For further information: Investors: BELLUS Health, François Desjardins, Vice-President, Finance, 450-680-4525, [email protected]; Solebury Trout, Marcy Nanus, 646-378-2927, [email protected]; Media: Solebury Trout, Brad Miles, 646-513-3125, [email protected]