Once-daily Extended-Release formulation
demonstrated equivalent bioavailability to twice-daily Immediate
Release formulation
Extended-Release formulation was well
tolerated, with the safety profile consistent with previous
camlipixant trials and no taste-related adverse events reported
Additional data to be presented at a future
medical conference
BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (“BELLUS Health” or the
“Company”), a clinical-stage biopharmaceutical company working to
better the lives of patients suffering from persistent cough,
starting with the development of camlipixant (BLU-5937) for the
treatment of refractory chronic cough (“RCC”), today announced
positive data from its Phase 1 bioavailability equivalence study
evaluating a once-daily Extended-Release (“ER”) formulation of
camlipixant in comparison to a twice-daily Immediate Release (“IR”)
formulation. Camlipixant is the Company’s twice-daily, oral P2X3
antagonist product candidate for the treatment of RCC currently
being investigated in the CALM Phase 3 program.
The ER formulation demonstrated equivalent bioavailability to
the IR formulation, with equivalent total systemic drug exposure
(90% geometric mean AUC∞ and 82% geometric mean AUC24h), as well as
equivalent minimum drug concentration (88% geometric mean C24h).
The ER formulation was well tolerated, with the safety profile
consistent with previous camlipixant trials and no taste-related
adverse events reported. These results establish proof of concept
for developing a once-daily ER formulation of camlipixant. To
continue the development of the once-daily ER formulation, the
Company intends to conduct a multiple dose study of the ER
formulation. A patent application has been filed covering
once-daily formulations of camlipixant.
“We are pleased with the outcome of the bioavailability
equivalence study, which establishes the proof of concept for
developing a once-daily formulation of camlipixant, our potentially
best-in-class P2X3 inhibitor in Phase 3 development,” commented
Roberto Bellini, President and Chief Executive Officer of BELLUS
Health. “At BELLUS Health, we are working to better the lives of
individuals suffering from persistent cough, and these results
reflect our continued progress to establish and differentiate
camlipixant as the market leading option for RCC patients. We look
forward to providing additional data from this study at an upcoming
medical conference.”
This Phase 1, open-label bioavailability equivalence study was
designed to assess the safety, tolerability, and pharmacokinetic
profile of a single dose, once-daily ER formulation of camlipixant
versus a twice-daily IR reference formulation (two single doses of
25 mg, 12 hours apart) in 16 healthy adult subjects.
About BELLUS Health
(www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company
working to better the lives of patients suffering from persistent
cough, starting with the development of camlipixant (BLU-5937) for
the treatment of refractory chronic cough (RCC). Camlipixant, the
Company’s lead asset, is an investigational P2X3 receptor
antagonist for the treatment of RCC, which is currently being
evaluated in the CALM Phase 3 clinical program. With no approved
treatments in the U.S., camlipixant has the potential to be a
breakthrough in the RCC treatment landscape.
Chronic cough is defined as a cough lasting longer than eight
weeks. When the cause of chronic cough cannot be identified or the
cough persists despite treatment of any associated condition, the
condition is referred to as RCC. RCC is a frequent, yet often
under-recognized, medical condition that has significant physical,
social, and psychological consequences on one’s quality of life.
There are currently no approved treatments for this condition in
the United States, European Union or the United Kingdom.
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 camlipixant (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 completion of its Phase 3 clinical trials of camlipixant in RCC
and the expected timing of topline results from CALM-1 and CALM-2
Phase 3 clinical trials, the timing and outcome of interactions
with regulatory agencies, the ability of BELLUS Health to validate
its use of the VitaloJAK cough monitoring system to the
satisfaction of relevant regulatory agencies, the potential
activity and tolerability profile, selectivity, potency and other
characteristics of camlipixant, 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 camlipixant,
including with respect to patient population, pricing and labeling
and potential treatment alternatives, BELLUS Health’s financial
position and sufficiency of cash resources to bring through topline
results of CALM-1 and CALM-2 clinical trials, timely or at all, and
the potential applicability of camlipixant and BELLUS Health’s P2X3
receptor platform to treat other disorders. Risk factors that may
affect BELLUS Health’s future results include but are not limited
to: the intended benefits, acceptability to regulatory agencies and
impact of its enrichment strategy, continuing feedback and
discussions with the FDA and other regulatory authorities regarding
the design of the CALM Phase 3 program, estimates and projections
regarding the size and opportunity of the addressable RCC market
for camlipixant, 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 camlipixant, that final data from studies and
clinical trials may differ from reported data from preliminary
studies or clinical trials 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 camlipixant 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.
Source: BELLUS Health Inc.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230405005361/en/
Ramzi Benamar Chief Financial Officer
rbenamar@bellushealth.com
Media: Julia Deutsch Solebury Strategic Communications
jdeutsch@soleburystrat.com
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