- 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.
About BLU-5937
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.
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.