– No Taste Loss at the Anticipated Therapeutic Doses –
– BLU-5937 is Shown to be Safe and Well Tolerated –
– Company Intends to Initiate a Clinical Phase 2 Study in Mid-2019; Top-line Results Expected in Mid-2020 –
– BELLUS Health to Host Conference Call and Live Webcast Tomorrow at 8:00 AM Eastern Time –
LAVAL, Quebec, Nov. 19, 2018 (GLOBE NEWSWIRE) — BELLUS Health Inc. (TSX:BLU) (“BELLUS Health” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapeutics for conditions with high unmet medical need, today announced positive top-line results from the clinical Phase 1 study for BLU-5937, its lead drug candidate for the treatment of chronic cough.
The Phase 1 top-line data demonstrated that BLU-5937 has a good safety and tolerability profile, as well as a pharmacokinetic profile supporting twice-a-day (BID) dosing. At the anticipated therapeutic doses of 50 to 100 mg, BLU-5937 did not cause any loss of taste perception; only 1 out of 24 subjects reported transient taste alteration. Based on these data, the Company intends to advance BLU-5937 into a clinical Phase 2 study in chronic cough patients beginning in mid-2019.
“We are very pleased with the results of the clinical Phase 1 study which show compelling safety, tolerability and pharmacokinetics for BLU-5937,” said Dr. Denis Garceau, Senior Vice President, Drug Development of BELLUS Health. “The clinical data confirm our expectation that at the anticipated therapeutic doses there is no or very limited effect on taste perception and further reinforce our position that BLU-5937 has the potential to be a best-in-class therapeutic for chronic cough patients. We believe the Phase 1 data provide strong support for our planned clinical Phase 2 study for BLU-5937, which we expect to initiate in mid-2019.”
“I am very enthusiastic about these positive top-line Phase 1 results for BLU-5937,” commented Dr. Jaclyn Smith, Professor of Respiratory Medicine at the University of Manchester in the United Kingdom and an Honorary Consultant at the University Hospital of South Manchester NHS Foundation Trust, and Chair of BELLUS Health’s Clinical Advisory Board. “The compelling product profile and none to minimal side effects on taste perception seen in this first-in-human study should greatly benefit chronic cough patients. This sets the stage for the further development of BLU-5937 and I look forward to continue working on the program, including as Principal Investigator for the Phase 2 study in chronic cough patients.”
BLU-5937 Clinical Phase 1 Study Data
The Phase 1 data demonstrated that BLU-5937 has an excellent pharmacokinetic profile. Plasma half-life was established at approximately 5 hours, supporting BID dosing. Based on pre-clinical efficacy studies and comparison with drug levels achieved with a clinically validated comparator, the Company anticipates that drug levels required for optimal inhibition of cough will be achieved at 50 mg or 100 mg BID.
BLU-5937 plasma concentration increased dose-proportionally and was not affected by food, supporting BLU-5937 administration without regard to meals.
The Phase 1 data also showed that BLU-5937 has a good safety and tolerability profile. The overall incidence of adverse events was comparable between placebo (56%) and BLU-5937 (47%).
There were no serious adverse events and no subjects withdrew prematurely due to an adverse event during the study. No significant trends of mean changes in vital signs, electrocardiogram (ECG) and clinical laboratory values have been observed in the Phase 1 study for BLU-5937.
No subject reported total loss of taste at any dose level. Only one subject out of 24 (4.2%) reported taste alteration at the anticipated therapeutic doses of 50-100 mg. This taste effect was reported only on the first day out of 7 days of dosing in a subject receiving 100 mg BID. At supra-therapeutic doses of 200 mg to 1200 mg, two subjects out of 48 (4.2%) reported mild, transient partial loss of taste and 13 subjects out of 48 (27.1%) reported taste alteration. No subject out of 16 reported any taste loss or taste alteration at 200 mg. All taste adverse events were transitory and sporadic in nature and almost all of them were mild. The other most frequent adverse events reported in the Phase 1 study (> 5%) for BLU-5937 were: headache (12.5%), numbness (11.1%), nausea (8.3%), dizziness (8.3%) and heartburn (5.6%).
BLU-5937 Clinical Phase 1 Study
The clinical Phase 1 study was a randomized, double-blind, placebo-controlled study of orally administered BLU-5937 in 90 healthy adult subjects. The primary objectives of the clinical Phase 1 study were to assess the safety, tolerability (including taste perception) and pharmacokinetic profile of BLU-5937 in healthy subjects.
The study was divided in two parts:
Part 1: A single ascending doses (SAD) study was conducted in 60 healthy subjects. Subjects were randomized into 6 cohorts of 10 subjects (8 BLU-5937: 2 placebo). The study evaluated single oral doses of BLU-5937 from 50 to 1200 mg.
Part 2: A multiple ascending doses (MAD) study was conducted in 30 healthy subjects. Subjects were randomized into 3 cohorts of 10 subjects (8 BLU-5937: 2 placebo). The study evaluated multiple oral doses of BLU-5937 of 100, 200 and 400 mg administered twice-a-day (BID) for 7 consecutive days.
BLU-5937 Clinical Phase 2 Study Design
Based on the positive top-line data from the Phase 1 study, BELLUS Health expects to initiate a 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 dose escalation crossover design study to assess the safety, tolerability and efficacy of BLU-5937 in chronic cough patients, in addition to helping confirm the optimal dose regimen. A total of 50 patients with refractory unexplained chronic cough are expected to be enrolled in approximately 10 clinical sites located in the United Kingdom and Unites States.
Conference Call Details
BELLUS Health will host a conference call and live webcast tomorrow, November 20 at 8:00 am ET to discuss the results of the Phase 1 study and to provide an update on the upcoming development efforts of BLU-5937 for the treatment of chronic cough, including the Phase 2 study design.
The conference call and live webcast can be accessed as follows:
Domestic (US): 1-888-224-1121
International: 1-323-794-2575
Conference ID: 9549357
Live webcast (with slides): https://viavid.webcasts.com/starthere.jsp?ei=1221461&tp_key=d49788a767
Following the event, the archived webcast and BELLUS Health’s presentation will be available on the Company’s website at www.bellushealth.com. The webcast will be archived for 1 year after the event.
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 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 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.
FOR MORE INFORMATION, PLEASE CONTACT:
François Desjardins
Vice President, Finance
450-680-4525
[email protected]
SOURCE: BELLUS Health Inc.
