- Study Results Expected in the Fourth Quarter of
2018 -
LAVAL, QC, July 9, 2018 /PRNewswire/ - 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 the initiation of
healthy subjects dosing in a Phase 1 clinical study for BLU-5937,
its lead drug candidate for the treatment of chronic cough.
Preclinical studies demonstrated that BLU-5937 is a highly
selective P2X3 antagonist exhibiting a potent anti-tussive effect
without affecting taste perception, with an excellent safety
profile.
The main objectives of the Phase 1 clinical study are to assess
the safety, tolerability (including taste perception) and
pharmacokinetic profile of BLU-5937 in healthy subjects. This is a
randomized, double-blind, placebo-controlled study of orally
administered BLU-5937 in up to 90 healthy adult subjects.
"We are excited to begin the first-in-human study of our lead
drug candidate BLU-5937," said Roberto
Bellini, president and CEO of BELLUS Health. "We expect
top-line Phase 1 data in the fourth quarter of 2018, where positive
results would solidify BLU-5937's potential as a best in class P2X3
antagonist for chronic cough."
The study will be divided in two parts:
Part 1: A single-ascending dose ("SAD") study will be conducted
in up to 60 healthy subjects. Subjects will be randomized into up
to 6 cohorts of 10 subjects (8 BLU-5937: 2 placebo).
Part 2: A multiple-ascending dose ("MAD") study will be
conducted in up to 30 healthy subjects. Subjects will be randomized
into up to 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 the safety, tolerability (including
taste perception) and dosing regimen for the Phase 2
proof-of-concept study.
The Phase 2 proof-of-concept study is expected to be initiated
in 2019 in chronic cough patients. This will be a dose escalation
study to assess the safety, tolerability and efficacy of
BLU-5937.
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 two separate preclinical models, BLU-5937 showed a
significant reduction in cough and no taste loss side effect. 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 was not associated with taste loss
whereas, consistent with clinical trial data previously presented
by Merck & Co, gefapixant led to significant taste loss.
The preclinical toxicology studies demonstrated an excellent
safety profile for BLU-5937.
BLU-5937 has obtained patent protection with claims covering the
composition of matter of BLU-5937 in three of the four major
pharmaceutical markets (U.S., China and Europe), with an expiration date of 2034.
Similar patent applications are currently pending in
Japan and other industrialized
nations.
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 highly
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.
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SOURCE BELLUS Health Inc.