September 18, 2017

BELLUS Health's BLU-5937 Significantly Reduces Cough Without Taste Disturbance in Two Preclinical Models

- BELLUS to provide BLU-5937 program update during September 20th webcast -
- Key Opinion Leader Dr. Jacky Smith to present on chronic cough -

LAVAL, QC, Sept. 18, 2017 /CNW/ - BELLUS Health Inc. (TSX: BLU) (BELLUS Health or the Company), a biopharmaceutical development company advancing novel therapeutics for conditions with high unmet medical need, today announced that its P2X3 antagonist drug candidate for chronic cough, BLU-5937, has shown a significant reduction in cough and no taste disturbance in two separate preclinical models. In the guinea pig cough model, BLU-5937 has shown comparable efficacy to the current leading P2X3 antagonist, Merck & Co's Gefapixant (also named AF-219 or MK-7264). In the rat taste model, BLU-5937 did not inhibit taste; however, consistent with clinical trial data previously presented by Merck & Co, Gefapixant did significantly impact taste.

"These preclinical data further support BLU-5937 as a potential best in P2X3 class anti-tussive drug that reduces cough with little or no taste effect," said Roberto Bellini, President and CEO of BELLUS Health. "We're looking forward to discussing these data in more detail and have KOL Dr. Smith present on the chronic cough therapeutic landscape during our September 20th event."

The Company's BLU-5937 program update and Key Opinion Leader (KOL) event will be webcast live on Wednesday September 20, 2017 at 2:00 pm Eastern Time. KOL Dr. Jacky Smith, Professor of Respiratory Medicine at the University of Manchester and Director of the NIHR South Manchester Respiratory and Allergy Clinical Research Facility, will discuss the clinical presentation of chronic cough, its current unmet medical need and therapeutic options, as well as novel treatment approaches under development.

Dr. Denis Garceau, BELLUS Health's Senior Vice President, Drug Development, will also provide an update on BLU-5937, including preclinical study results and development path. 

Both Dr. Smith and Dr. Garceau will be available to answer questions at the end of their presentations.

To listen to the live webcast or to ask questions during the live event, please register at the following link: https://event.webcasts.com/starthere.jsp?ei=1159556&tp_key=4a0ae58b66. To ensure a timely connection to the webcast, it is recommended that listeners pre-register no later than 15 minutes prior to the scheduled start time. An archived version of the webcast and presentation will be available on the Company's website at www.bellushealth.com following the event.

BLU-5937's Reduction in Cough Frequency Comparable to the Leading P2X3 Antagonist, Gefapixant

The anti-tussive effect of BLU-5937 was compared to that of Gefapixant in a guinea pig cough model.  Treatments (control, BLU-5937 (0.3, 3 and 30 mg/kg) or Gefapixant (0.3, 3 or 30 mg/kg)) were administered orally in seven groups of 6 animals 2 hours prior to tussive agent exposure (citric acid and histamine) and the number of coughs were counted for a period of 15 minutes. Both treatments showed comparable dose-dependent reduction in cough frequency as compared to the control. The reduction in cough was statistically significant at 3 mg/kg (39% vs. control) and 30 mg/kg (52% vs. control) with BLU-5937, and at 30 mg/kg (45% vs. control) with Gefapixant.

BLU-5937's Duration of Effect also Comparable to Gefapixant

Using the same guinea pig cough model, a time course study was conducted to assess the duration of the anti-tussive effect of BLU-5937 and Gefapixant following the administration of a single oral 30 mg/kg dose. In this study, animals in groups of 6 were exposed to tussive agents (citric acid and histamine) at various times after the administration of the study drugs (2, 4, 6, 8 and 12 hours post-dose for BLU-5937 and 2 and 8 hours post-dose for Gefapixant) and the number of coughs were measured for 15 minutes. The reduction in cough frequency compared to control was shown to be statistically significant at 2, 4 and 6 hours post-dose with BLU-5937, and at 2 hours post-dose with Gefapixant. The anti-tussive effect was no longer significant at 8 hours post-dose for both agents. These results indicate that BLU-5937 and Gefapexiant have comparable duration of effect.

BLU-5937 Shows No Impact on Taste, Leading P2X3 Antagonist Gefapixant Shows Significant Taste Disturbance in the Rat Taste Model

A rat taste model was used to compare BLU-5937's effect on taste function with that of Gefapixant. Animals were water-fasted overnight and presented with one bottle of water and one bottle of (bitter-tasting) quinine at the time corresponding to the maximum plasma concentration of study drugs; and the volume of liquid consumed from each bottle was measured for 15 minutes. Treatments (control, BLU-5937 (10 or 20 mg/kg) or Gefapixant (10 or 20 mg/kg)) were administered intraperitoneally in two groups of 10 rats. Animals treated with BLU-5937 did not drink more quinine than the control animals, while those treated with Gefapixant drank significantly (approximately 5 times) more quinine than the control at the two doses tested. These results indicate that Gefapixant altered taste function, while BLU-5937 did not.

About BLU-5937

BLU-5937, a selective P2X3 antagonist, has the potential to be a best-in-class therapeutic for chronic cough patients who do not respond to current therapies. 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. It is estimated that more than 2.7 million patients suffer from refractory chronic cough in the United States alone.

About BELLUS Health (www.bellushealth.com)

BELLUS Health is a biopharmaceutical development company advancing novel therapeutics for conditions with high unmet medical need. Its pipeline of projects includes 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. The Company 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.

François Desjardins, Vice-President, Finance, BELLUS Health Inc., 450-680-4525, fdesjardins@bellushealth.com

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