Topline results expected in Q4 2021
BELLUS Health Inc. (Nasdaq:BLU; 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
first patient has been dosed in the Phase 2 BLUEPRINT trial of
BLU-5937, the Company’s highly selective P2X3 antagonist, in
patients with chronic pruritus associated with atopic
dermatitis.
“The initiation of the BLUEPRINT trial marks a key step forward
in evaluating BLU-5937’s potential broad applicability across
chronic disorders triggered by hypersensitization,” commented
Roberto Bellini, President and CEO of BELLUS Health. “Chronic
pruritus, the second indication we are pursuing with our P2X3
antagonist BLU-5937, is the hallmark and one of the most burdensome
symptoms of atopic dermatitis, significantly affecting an
individual’s quality of life. We believe BLU-5937 has the potential
to significantly alleviate an atopic dermatitis patient’s urge to
scratch and look forward to reporting topline data from this trial
in the fourth quarter of 2021.”
The BLUEPRINT study is a multicenter, randomized, double-blind,
placebo-controlled, parallel-design Phase 2 trial evaluating the
efficacy, safety and tolerability of BLU-5937 in approximately 128
adult patients with moderate to severe chronic pruritus associated
with mild to moderate atopic dermatitis. Patients will be
randomized into one of two treatment arms (1:1) and will receive
either 200 mg BID of BLU-5937 or placebo for a four-week treatment
period. The primary efficacy endpoint will be the change from
baseline in weekly mean Worst Itch-Numeric Rating Scale (WI-NRS)
score at week four. A key secondary endpoint will be a
responder-rate analysis of at least a four-point WI-NRS improvement
from baseline at week four.
The study will be performed at approximately 29 study centers
located in Canada and the United States.
About BLU-5937
BLU-5937, a highly selective P2X3 antagonist - (>1500 fold) -
is in development for chronic cough, chronic pruritus and other
hypersensitization-related disorders.
The P2X3 receptor in the cough reflex pathway, which is
implicated in chronic cough, is a rational target for treating
chronic cough, and it has been evaluated in multiple clinical
trials with different P2X3 antagonists. The Company believes that
its highly selective P2X3 antagonist has the potential to reduce
coughing in patients with refractory chronic cough while limiting
taste disturbance adverse events.
In addition to chronic cough and chronic pruritus, BLU-5937 may
also have broad applicability across other afferent
hypersensitization-related disorders, enabling the Company to
consider developing a pipeline of therapies using its P2X3
platform. BELLUS Health is exploring how P2X3 activation can
contribute to irritation and pain, and whether inhibition of P2X3
receptors can help treat these afferent hypersensitization-related
disorders.
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
product candidate, BLU-5937, is being developed for the treatment
of chronic cough and chronic pruritus.
Chronic cough, the lead indication for BLU-5937, 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
approximately 3 million having refractory chronic cough lasting for
more than a year and approximately 6 million having refractory
chronic cough lasting more than 8 weeks and under one year. There
is no specific therapy approved for refractory chronic cough and
current treatment options are limited.
Chronic pruritus, the second indication for BLU-5937, is
commonly known as chronic itch and is an irritating sensation that
leads to scratching and persists for longer than six weeks, which
can be debilitating and can significantly impact quality of life.
It is a hallmark of many inflammatory skin diseases, including AD.
It is estimated that AD afflicts approximately 5% of adults in the
United States. Despite currently available treatments targeting AD,
there continues to be a lack of options targeting the burden of
pruritus in AD patients.
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, the
U.S. Private Securities Litigation Reform Act of 1995, as amended,
and other applicable securities laws. Forward-looking statements
are frequently, but not always, identified by words such as
“expects,” “anticipates,” “believes,” “intends,” “estimates,”
“potential,” “possible,” “projects,” “plans,” and similar
expressions. 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's control. Such statements include,
but are not limited to, the potential of BLU-5937 to successfully
treat chronic cough, chronic pruritus and other
hypersensitization-related disorders, BELLUS Health’s expectations
related to its preclinical studies and clinical trials, including
the design and timing of its Phase 2 clinical trial of BLU-5937 in
chronic pruritus associated with AD, including the potential
activity and tolerability profile, selectivity, potency and other
characteristics of BLU-5937, including as compared to other
competitor candidates, and the potential applicability of BLU-5937
and BELLUS Health’s P2X3 platform to treat other disorders. Risk
factors that may affect BELLUS Health’s future results include but
are not limited to: estimates and projections regarding the size
and opportunity of the addressable refractory chronic cough market
and chronic pruritus market for BLU-5937, the ability to expand and
develop its product pipeline, the ability to obtain adequate
financing, the ability to maintain its rights to intellectual
property and obtain adequate protection of future products through
such intellectual property, the impact of general economic
conditions, general conditions in the pharmaceutical industry, the
impact of the COVID-19 pandemic on its operations, plans and
prospects, including to the initiation and completion of clinical
trials in a timely manner or at all, changes in the regulatory
environment in the jurisdictions in which it does business, stock
market volatility, fluctuations in costs, changes to the
competitive environment due to consolidation, achievement of
forecasted burn rate, achievement of forecasted preclinical study
and clinical trial milestones, reliance on third parties to conduct
preclinical studies and clinical trials for BLU-5937 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 its product candidate’s development process and its
market size and commercial value are dependent upon a number of
factors. Moreover, BELLUS Health’s growth and future prospects are
mainly dependent on the successful development, patient
tolerability, regulatory approval, commercialization and market
acceptance of its product candidate BLU-5937 and other products.
Consequently, actual future results and events may differ
materially from the anticipated results and events expressed in the
forward-looking statements. BELLUS Health 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 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's public filings with the Canadian
securities regulatory authorities, including, but not limited to,
its Annual Information Form, and the United States Securities and
Exchange Commission, including, but not limited to, its Annual
Report on Form 40-F, for further risk factors that might affect
BELLUS Health and its business.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201214005244/en/
Danny Matthews Director, Investor Relations and Communications
danny@bellushealth.com
Media: Julia Deutsch Solebury Trout
jdeutsch@soleburytrout.com
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