Topline results from both studies are expected
in December 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 refractory chronic cough
and other hypersensitization-related disorders, today announced
that the Company has completed patient enrollment in the Phase 2b
SOOTHE clinical trial of BLU-5937 in refractory chronic cough
(“RCC”) and the Phase 2a BLUEPRINT clinical trial of BLU-5937 in
chronic pruritus associated with atopic dermatitis (“AD”). Topline
results from both trials are expected in December 2021.
“Completion of enrollment in our SOOTHE trial marks an important
milestone, underscoring the progress we have made advancing
BLU-5937 for the treatment of RCC. As recently reported, we are
encouraged by the positive outcome of our recent administrative
interim analysis from the SOOTHE trial, and look forward to sharing
topline results from both SOOTHE and our Phase 2a BLUEPRINT trial
in chronic pruritus in December 2021,” said Roberto Bellini,
President and Chief Executive Officer of BELLUS Health. “Chronic
cough and chronic pruritis negatively impact individuals’ quality
of life, and each indication represents a significant unmet medical
need. We are grateful to the patients and clinical investigators
who are participating in our trials.”
BELLUS Health previously announced on September 13, 2021 results
from a planned administrative interim analysis of the Phase 2b
SOOTHE trial in RCC. An independent statistical team reported that
a predefined stringent probability threshold for clinical efficacy
was met for at least one and up to all three doses of BLU-5937
tested. In addition, the analysis reported that limited
taste-related adverse events were observed, consistent with
previous trials of BLU-5937, and no serious adverse events were
reported.
About SOOTHE
The SOOTHE trial is a multicenter, randomized, double-blind,
four-week, parallel arm, placebo-controlled Phase 2b trial
evaluating three doses of BLU-5937 (12.5 mg, 50 mg and 200 mg BID)
in 310 participants with RCC. A total of 249 participants with a
baseline awake cough frequency of ≥25 awake coughs per hour were
randomized across four arms (1:1:1:1) evaluating the three active
doses of BLU-5937 and placebo in the main study. Treatment arms
were stratified to balance the number of participants with baseline
awake cough frequency ≥45 coughs per hour across trial arms. The
primary efficacy endpoint is the placebo-adjusted change in the
24-hour cough frequency from baseline to day 28 collected with a
cough recorder. An exploratory group of an additional 61
participants with a baseline awake cough frequency of ≥10 and
<25 coughs per hour were randomized across 2 arms (1:1)
evaluating one active dose (200 mg BID) and placebo to further
investigate the effect of BLU-5937 in patients with lower cough
frequency. More information about the trial is available at
www.clinicaltrials.gov: NCT04678206.
About BLUEPRINT
The BLUEPRINT trial is a multicenter, randomized, double-blind,
placebo-controlled, parallel-design Phase 2a trial evaluating the
efficacy, safety and tolerability of BLU-5937 in 142 participants
with moderate to severe chronic pruritus associated with mild to
moderate AD. Participants were randomized into one of two treatment
arms (1:1) and receive either 200 mg BID of BLU-5937 or placebo for
a four-week treatment period. The primary efficacy endpoint is the
change from baseline in weekly mean Worst Itch-Numeric Rating Scale
(WI-NRS) score at week four. A key secondary endpoint is a
responder-rate analysis of at least four-point WI-NRS improvement
from baseline at week four. More information about the trial is
available at www.clinicaltrials.gov: NCT04693195.
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, the ability of the interim analysis
to predict the final results of the SOOTHE trial, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210923005117/en/
FOR MORE INFORMATION: Ramzi Benamar Chief Financial
Officer rbenamar@bellushealth.com Media: Julia Deutsch
Solebury Trout jdeutsch@soleburytrout.com Source: BELLUS Health
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