Interim analysis met the threshold for a high
probability of clinical efficacy
Data from interim analysis support accelerated
planning for the Phase 3 program
SOOTHE Phase 2b trial is on track to deliver
topline results 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 refractory chronic cough
and other hypersensitization-related disorders, today announced
positive findings from a preplanned administrative interim analysis
of the ongoing Phase 2b SOOTHE trial of BLU-5937, the Company’s
highly selective P2X3 antagonist, in patients with refractory
chronic cough (“RCC”).
An independent statistical team reported that the predefined
stringent probability threshold for clinical efficacy was met for
at least one dose of BLU-5937. The following observations of the
interim data were made regarding key aspects of the BLU-5937
product profile:
- At least one dose of BLU-5937 met the
stringent predefined probability threshold for a clinically
meaningful reduction in placebo-adjusted 24-hour cough
frequency;
- Limited taste-related adverse events were
observed, consistent with previous BLU-5937 trials;
- No serious adverse events were
reported.
“We believe the encouraging SOOTHE Phase 2b trial interim
analysis will enable us to accelerate the planning for our Phase 3
program while awaiting SOOTHE final results,” said Roberto Bellini,
President and Chief Executive Officer of BELLUS Health. “With trial
enrollment progressing as planned, we anticipate announcing topline
data in the fourth quarter of 2021.”
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 300 participants with refractory chronic cough. 240 participants
with a baseline awake cough frequency of ≥25 awake coughs per hour
are expected to be randomized across four arms (1:1:1:1) evaluating
the three active doses of BLU-5937 and placebo in the main study.
Treatment arms will be stratified to balance the number of
participants with baseline awake cough frequency ≥45 coughs per
hour across trial arms. The primary efficacy endpoint will be 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 60 participants with a baseline awake cough
frequency of ≥10 and <25 coughs per hour are expected to be
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 the Interim Analysis
An independent statistical team conducted the preplanned interim
analysis once half of the total participants in the main trial
completed their treatment period. The interim analysis was
performed for administrative purposes and has no impact on the
design or future conduct of the SOOTHE trial. Trial participants
will continue to be enrolled and followed to trial completion.
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/20210913005359/en/
FOR MORE INFORMATION: Ramzi Benamar Chief Financial
Officer rbenamar@bellushealth.com
Media: Julia Deutsch Solebury Trout
jdeutsch@soleburytrout.com
Immucor, Inc. (MM) (NASDAQ:BLUD)
Historical Stock Chart
From May 2024 to Jun 2024
Immucor, Inc. (MM) (NASDAQ:BLUD)
Historical Stock Chart
From Jun 2023 to Jun 2024