- Completed studies required to submit clinical trial application for BLU-5937 for chronic cough -
- Announces voting results from Annual Meeting -

LAVAL, QC, May 15, 2018 /CNW/ - BELLUS Health Inc. BLU (BELLUS Health or the Company), a biopharmaceutical development company advancing novel therapeutics for conditions with high unmet medical need, today reported its financial and operating results for the first quarter ended March 31, 2018. All currency figures reported in this press release are in Canadian dollars, unless otherwise specified.

Recent Highlights

• Completed all preclinical studies on BLU-5937 for chronic cough needed to submit a Clinical Trial Application ("CTA") to Health Canada; expects to initiate a Phase 1 clinical study in the third quarter of 2018;
• Completed 28-day toxicology preclinical studies further demonstrating BLU-5937's excellent safety profile;
• Patent granted by the European Patent Office ("EPO") in April 2018 with claims covering the composition of matter of BLU-5937 until 2034;
• Concluded the quarter with cash, cash equivalents and short-term investments totalling $21.7 million.

"Having completed the required preclinical studies on BLU-5937, we are now ready to file a CTA with Health Canada in Q2 2018", said Roberto Bellini, President and Chief Executive Officer of BELLUS Health. "Our first-in-human study is expected to begin in Q3 2018 and report in Q4 2018, providing important value-driving information on BLU-5937's safety and tolerability, including taste perception and dose regimen, which are key factors in BLU-5937's potential best-in-class profile."

BLU-5937 for Chronic Cough

The Company's lead drug candidate is BLU-5937, 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 two separate preclinical models, BLU-5937 showed a significant reduction in cough and no effect on taste perception. In a guinea pig cough model, BLU-5937 showed comparable anti-tussive efficacy to the current leading P2X3 antagonist in development, Merck & Co's Gefapixant (also named AF-219 or MK-7264). In a rat taste model, BLU-5937 did not change taste perception whereas, consistent with clinical trial data previously presented by Merck & Co, Gefapixant led to significant change in taste perception (alteration or loss).

The Company has completed all preclinical studies on BLU-5937 needed to submit a CTA, including 28-day toxicology animal studies, which demonstrated an excellent safety profile. The Company expects to submit the CTA to Health Canada in the second quarter of 2018 to initiate a Phase 1 clinical study on humans in the third quarter of 2018.

The main objectives of the Phase 1 clinical study will be to assess the safety, tolerability (including taste perception) and pharmacokinetic profile of BLU-5937 in healthy subjects. This will be a randomized, double-blind, placebo-controlled, single- and multiple-dose escalating study of orally administered BLU-5937 in healthy adult subjects.

Subject to final regulatory approval, the study will be designed as follows:

Part 1: A single-ascending dose ("SAD") study will be conducted in approximately 60 healthy subjects. Subjects will be enrolled into approximately 6 cohorts of 10 subjects (8 BLU-5937: 2 placebo).

Part 2: A multiple-ascending dose ("MAD") study will be conducted in approximately 30 healthy subjects. Subjects will be enrolled into approximately 3 cohorts of 10 subjects (8 BLU-5937: 2 placebo). Each subject will receive daily oral administrations of the assigned treatment for 7 consecutive days. The dose regimen for the MAD study will be established based on the SAD study results.

Results of the Phase 1 clinical study are expected in the fourth quarter of 2018. These results will help define BLU-5937's expected product profile, including: safety, tolerability (including taste perception) and dosing regimen.

On April 4, 2018, the EPO granted a patent with claims covering the composition of matter of BLU-5937, with an expiration date of 2034. BLU-5937 has now obtained patent protection in three of the four major pharmaceutical markets, with equivalent patents issued in 2017 in the U.S. and China with similar broad claims. Similar patent applications are currently pending in Japan and other industrialized nations.

Other Development Programs

Information on the Company's other partnered development programs – KIACTA™ for Sarcoidosis, AMO-01 for intellectual disabilities and ALZ-801 for APOE4 Homozygous Alzheimer's Disease – can be found on the Company's website at www.bellushealth.com.

Summary of Financial Results

 

• Research and development expenses, net of research tax credits, amounted to $1,245,000 for the three-month period ended March 31, 2018, compared to $251,000 for the corresponding period the previous year. The increase is attributable to higher expenses incurred in relation to the development of BLU-5937, the Company's lead drug candidate for chronic cough.
• General and administrative expenses amounted to $704,000 for the three-month period ended March 31, 2018, compared to $566,000 for the corresponding period the previous year. The increase is mainly due to higher stock-based compensation expense in relation to the Company's stock option plan and deferred share unit plans.
• Net finance income amounted to $97,000 for the three-month period ended March 31, 2018, compared to $8,000 for the corresponding period the previous year. The increase is primarily attributable to higher interest income due to the Company's increased cash position following the equity offering in December 2017.
• Gain on sale of subsidiary amounted to nil for the three-month period ended March 31, 2018, compared to $1,944,000 for the corresponding period the previous year, and is related to the sale of the Company's wholly-owned subsidiary, Thallion Pharmaceuticals Inc., in March 2017.

As at March 31, 2018, the Company had available cash, cash equivalents and short-term investments totalling $21,731,000, compared to $23,888,000 as at December 31, 2017.

The Company's full unaudited condensed consolidated interim financial statements and accompanying management's discussion and analysis for the three-month period ended March 31, 2018 will be available shortly on SEDAR at www.sedar.com and on the Company's website at www.bellushealth.com.

BELLUS Health Announces Election of Directors at Annual Meeting

At the Annual Meeting of Shareholders held today in Laval, Quebec, each director nominee listed in the Management Information Circular dated March 13, 2018 was elected as a Director of the Company.

The details of the election are as follows:

 

The results of the final votes regarding all matters subject to a vote during the Annual Meeting that took place today will be made available on SEDAR's website (www.sedar.com).

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 the Company's lead drug candidate BLU-5937 for chronic cough and several other partnered clinical-stage drug development programs. 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. 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.

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.

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