BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (“BELLUS Health” or the
“Company”), a clinical-stage biopharmaceutical company developing
novel therapeutics for the treatment of refractory chronic cough
(“RCC”) and other hypersensitization-related disorders, today
announced that an abstract covering additional data from the RELIEF
Phase 2a trial has been accepted for oral presentation at the
upcoming European Respiratory Society (“ERS”) International
Congress 2021, being held September 5-8, 2021.
“Refractory chronic cough can be a debilitating condition that
impacts a patient’s everyday life. With limited therapy options
available, there is a significant need for new treatments that
reduce cough, improve a patient’s quality of life and are well
tolerated. P2X3 antagonists, an emerging new class of therapy for
refractory chronic cough, have shown promise in addressing the
burden of this condition on patients,” commented Catherine
Bonuccelli, M.D., Chief Medical Officer of BELLUS Health. “In our
Phase 2a RELIEF trial, we observed improvements in cough severity
and quality of life over a 16-day treatment period that favored our
P2X3 antagonist, BLU-5937. These positive trends suggest that over
a longer period of time, BLU-5937 may show greater treatment
benefit. We are encouraged by these results and based on the design
of our ongoing Phase 2b SOOTHE trial, we are confident that we can
demonstrate improvements in cough severity and quality of
life.”
Oral Presentation Details: Title: Improvements in cough
severity and cough-related quality of life in a phase 2 trial with
the P2X3 antagonist BLU-5937 in refractory chronic cough
Session: Clinical trials in airway diseases: novel
treatments and new evidence Format: Pre-recorded
presentation and live QA Date: Sunday, September 5, 2021
Time: 8:45 a.m. EDT/2:45 p.m. CET
For more information and to access the pre-recorded
presentation, please visit the ERS congress platform. Following the
conference, the presentation materials will be available in the
“Scientific Publications” section of BELLUS Health's website at
www.bellushealth.com.
About BLU-5937
BLU-5937, a highly selective P2X3 antagonist, is in development
for RCC, chronic pruritus and other hypersensitization-related
disorders.
The P2X3 receptor, which is implicated in cough reflex
hypersensitization, 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 RCC, while limiting taste disturbance adverse
events.
In addition to RCC and chronic pruritus, the mechanism of
BLU-5937 may also have broad therapeutic applicability across other
afferent hypersensitization-related disorders, enabling the Company
to consider BLU-5937 as a potential treatment for a number of other
indications. Consequently, BELLUS Health is exploring how the P2X3
pathway may contribute to irritation and pain in a variety of
afferent hypersensitization-related disorders and whether
inhibition of P2X3 receptors can help treat these conditions.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company
developing novel therapeutics for the treatment of RCC and other
hypersensitization-related disorders. The Company's product
candidate, BLU-5937, is being developed for the treatment of RCC
and chronic pruritus associated with AD.
RCC is a cough lasting more than 8 weeks despite appropriate
treatment for underlying condition(s). It is estimated that there
are approximately 9 million patients in the United States suffering
from RCC. RCC is associated with significant adverse physical,
social, and psychosocial effects on health and quality of life.
Currently, there is no specific therapy approved for RCC and
treatment options are limited.
Chronic pruritus associated with AD is an irritating sensation
that leads to scratching and persists for longer than 6 weeks in AD
patients. It is estimated that up to 10% of adults in the United
States suffer from AD – almost all report symptoms of pruritus with
over 50% of patients attributing chronic pruritus as their most
burdensome symptom. Despite currently available treatments
targeting AD, there continues to be a lack of options specifically
targeting the burden of pruritus in patients with AD.
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 2b
clinical trial of BLU-5937 in RCC and its Phase 2a clinical trial
of BLU-5937 in chronic pruritus associated with AD, including the
timing and outcome of interactions with regulatory agencies, the
potential activity and tolerability profile, selectivity, potency
and other characteristics of BLU-5937, including as compared to
other competitor candidates, the commercial potential of BLU-5937,
including with respect to patient population, pricing and labeling,
BELLUS Health’s financial position, 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: the benefits and impact on
label of its enrichment strategy, estimates and projections
regarding the size and opportunity of the addressable RCC market
for BLU-5937, the ability to expand and develop its project
pipeline, the ability to obtain adequate financing, the ability of
BELLUS Health 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 BELLUS Health’s 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 BELLUS Health 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 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 BELLUS Health’s
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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210823005178/en/
Ramzi Benamar Chief Financial Officer
rbenamar@bellushealth.com
Media: Julia Deutsch Solebury Trout
jdeutsch@soleburytrout.com
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