- CALM Phase 3 program consists of two pivotal
trials (CALM-1 and CALM-2), with primary efficacy endpoint of
24-hour cough frequency measured at 12- and 24-weeks, respectively
-
- The Company has reached alignment with FDA on
the primary efficacy endpoint of 24H cough frequency reduction
being assessed using the VitaloJAK cough monitoring system in a
patient population enriched for baseline cough frequency -
- First patient expected to be enrolled in the
fourth quarter of 2022; Topline results from CALM-1 expected in 2H
2024 -
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 cough hypersensitivity indications, today
announced a positive End-of-Phase 2 (“EOP2”) meeting with the U.S.
Food and Drug Administration (“FDA”) and the details of the CALM
Phase 3 program for BLU-5937, a highly selective, second generation
P2X3 antagonist product candidate, for the treatment of refractory
chronic cough (“RCC”).
“The successful completion of our End-of-Phase 2 meeting with
the FDA marks a significant milestone for BELLUS. We are
appreciative of the FDA’s support and guidance and are pleased to
have identified a clear regulatory path to a potential approval for
BLU-5937,” commented Roberto Bellini, President and Chief Executive
Officer of BELLUS Health. “Based on our SOOTHE Phase 2b data, we
remain confident in BLU-5937’s potential to be a best-in-class
treatment option for RCC patients, if approved. We are well
positioned to execute our CALM Phase 3 program, with cash resources
sufficient to bring us through topline results with CALM-1, and we
look forward to initiating this pivotal program in the fourth
quarter.”
Based on the FDA's feedback, the CALM Phase 3 program is
composed of two pivotal trials, CALM-1 and CALM-2, each evaluating
the efficacy, safety and tolerability of BLU-5937 in approximately
675 adults with RCC. CALM-1 and CALM-2 will be placebo-controlled,
parallel-arm trials randomized 1:1:1 with expected treatment arms
of 25 mg BID, 50 mg BID and placebo. The primary endpoint of 24H
cough frequency will be measured at 12-weeks for CALM-1 and
24-weeks for CALM-2. The Company has reached alignment with the FDA
that the CALM Phase 3 program’s primary endpoint, similar to the
successful SOOTHE Phase 2b trial, can be assessed using the
VitaloJAK cough monitoring system in a patient population enriched
for baseline 24H cough frequency of ≥20 coughs/hour (equivalent to
awake cough frequency of ≥25 coughs/hour used in SOOTHE Phase 2b
trial). Key secondary efficacy endpoints include Cough Severity
using Visual Analogue Scale (“CS-VAS”), the Leicester Cough
Questionnaire (“LCQ”) and Chronic Cough Diary (“CCD”). The CALM
Phase 3 trials will also enroll participants with baseline 24H
cough frequency <20 coughs/hour. A key secondary efficacy
endpoint will assess reduction in cough frequency in a broader
population including the enriched population and additional
participants with baseline 24H cough frequency below 20
coughs/hour. CALM-1 will have a 40-week randomized extension period
and an additional 24-week open label extension. CALM-2 will have a
28-week open label extension. The trials are planned to run in
parallel, and the Phase 3 CALM program is expected to enroll its
first patient in the fourth quarter of 2022. Topline data from
CALM-1 are expected in the second half of 2024.
About BLU-5937
BLU-5937, a highly selective P2X3 antagonist, is in development
for RCC and other cough hypersensitivity indications.
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 cough
frequency in patients with RCC and improve quality of life while
limiting taste disturbance adverse events.
In addition to RCC, the mechanism of action of BLU-5937 may also
have broad therapeutic applicability across other cough
hypersensitivity indications. The Company is evaluating potential
opportunities to study BLU-5937 in additional cough indications
where cough hypersensitivity plays an important role.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company
developing novel therapeutics for the treatment of RCC and other
cough hypersensitivity indications. The Company's product
candidate, BLU-5937, has successfully completed a Phase 2b trial in
RCC. BELLUS Health is planning a Phase 3 program, which is expected
to begin enrollment in the fourth quarter of 2022.
Chronic cough is a cough lasting longer than eight weeks. When
the cause of chronic cough cannot be identified or the cough
persists despite treatment of all identified associated causes, the
condition is referred to as RCC. 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 psychological effects on health and quality of life.
Currently, there is no specific therapy approved for RCC and
treatment options are limited.
The Company is exploring the potential use of BLU-5937 in other
patient populations experiencing cough hypersensitivity as well as
other P2X3-related hypersensitization conditions.
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 RCC and other hypersensitization-related disorders and
benefit such patients, BELLUS Health’s expectations related to its
preclinical studies and clinical trials, including the timing of
initiation of and the design of its Phase 3 clinical trials of
BLU-5937 in RCC, 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,
especially where head-to-head studies have not been conducted and
cross-trial comparisons may not be directly comparable due to
differences in study protocols, conditions and patient populations,
the commercial potential of BLU-5937, including with respect to
patient population, pricing and labeling, BELLUS Health’s financial
position and sufficiency of cash resources to bring through topline
results with CALM-1, 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 ongoing 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, supply
chain impacts, 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 differ from topline results
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/20220712005444/en/
Ramzi Benamar Chief Financial Officer rbenamar@bellushealth.com
Media: Julia Deutsch Solebury Trout
jdeutsch@soleburytrout.com Source: BELLUS Health Inc.
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