BELLUS Health Announces Issuance of New U.S. Patent Claiming P2X3 Selectivity as a Means of Minimizing Taste Effects for its Lead Chronic Cough Drug Candidate BLU-5937
– New Patent Extends BLU-5937’s Patent Protection to 2038 –
– Expands Portfolio That Also Includes Patent Protection for Composition of Matter for BLU-5937 in All Major Pharmaceutical Markets –
LAVAL, QC, Oct. 31, 2018 /CNW/ – BELLUS Health Inc. (TSX:BLU.TO – News) (« BELLUS Health » or the « Company »), a clinical-stage biopharmaceutical company developing novel therapeutics for conditions with high unmet medical need, today announced that the U.S. Patent and Trademark Office has issued U.S Patent No. 10,111,883, granting claims for the use of BELLUS Health’s lead drug candidate BLU-5937 for the treatment of chronic cough without affecting taste response. More generally, the patent entitled « Selective P2X3 Modulators » claims the use of imidazopyridine compounds that are selective for the P2X3 receptor as a means of minimizing taste perturbation in patients treated for chronic cough. In addition to BLU-5937, the patent claims the use of related selective imidazopyridine compounds and pharmaceutical compositions comprising BLU-5937. Patent No. 10,111,883 has an expiration date of 2038, excluding any potential patent term extension.
This patent adds to BLU-5937’s intellectual property portfolio which already includes composition of matter patent protection for BLU-5937 in all major pharmaceutical markets (U.S., Europe, Japan and China) until 2034.
« In multiple clinical trials, treating with a P2X3 antagonist was shown to be highly efficacious in the treatment of chronic cough » said Roberto Bellini, President and CEO of BELLUS Health. « However, this anti-tussive efficacy comes coupled with a profound effect on taste perception, including taste loss, due to poor selectivity for the P2X3 receptor. This new U.S. patent affords a broad and comprehensive protection for our lead drug candidate BLU-5937 claiming the compound’s selectivity as a means of minimizing deleterious taste effects and extends the patent protection of BLU-5937 by an additional 4 years ».
About BLU-5937 for Chronic Cough
BLU-5937 is a potent, highly selective, orally bioavailable small molecule antagonist of the P2X3 receptor, a clinically validated target for chronic cough. BLU-5937 has the potential to be a best-in-class therapeutic for chronic cough patients who do not respond to current therapies.
In July 2018, BELLUS Health initiated a clinical Phase 1 study for BLU-5937 in healthy subjects. Results are expected in the fourth quarter of 2018. A clinical Phase 2 study is expected to be initiated in 2019 in chronic cough patients.
In preclinical studies, BLU-5937 exhibited an excellent safety profile and a potent anti-tussive effect without affecting taste perception.
Chronic cough is a cough that lasts more than eight weeks and is associated with significant adverse social, psychosocial and physical effects on quality of life. A recent commercial assessment performed by Torreya Insights on behalf of the Company concluded that, in the United States alone, more than 26 million adults have chronic cough and more than 2.6 million of these patients suffer from refractory chronic cough lasting for more than a year.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company developing novel therapeutics for conditions with high unmet medical need. Its pipeline of projects includes the Company’s lead drug candidate BLU-5937 for chronic cough and several other partnered clinical-stage drug development programs.
Forward-Looking Statements
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.