- Double-blind, 4-week placebo controlled,
parallel arm trial will evaluate the efficacy and safety of 3 doses
of BLU-5937 in 280 patients with refractory chronic cough –
- Trial to recruit patients with baseline cough
count ≥25 coughs per hour -- RELIEF Phase 2 trial results
demonstrated significant reductions in cough frequency in
pre-specified analyses with patients ≥32 coughs/hour (50% of trial
participants) and ≥20 coughs/hour (80% of trial participants) at
baseline -
- Phase 2b trial expected to initiate in Q4
2020 with interim analysis in mid-2021 and topline data in 2H 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 the
planned trial design for SOOTHE, the Company’s Phase 2b dose
confirmation trial evaluating the efficacy and safety of BLU-5937
in refractory chronic cough (RCC). The Phase 2b trial is designed
based on the results from the Company’s previous Phase 2 RELIEF
trial including the finding that baseline cough frequency is a key
indicator of treatment benefit.
“Building on the results from our RELIEF trial where there was a
significant and clinically meaningful improvement observed in
patients with baseline cough frequencies ≥20 coughs per hour when
treated with BLU-5937, we believe our plan to recruit patients with
baseline cough frequencies >25
coughs per hour for the SOOTHE trial provides the best strategy for
success in this patient population,” said Cathy Bonuccelli, Chief
Medical Officer at BELLUS Health. “Additional exploratory arms of
patients with baseline cough frequencies <25 coughs per hour
will allow us to collect additional data to better inform the
design of our Phase 3 program.”
SOOTHE Phase 2b Trial Design
The SOOTHE Phase 2b trial is planned as a multicenter,
randomized, double-blind, 4-week, parallel arm study evaluating
three doses of BLU-5937 (12.5 mg, 50 mg and 200 mg BID) in 280
patients with refractory chronic cough versus placebo. 240
participants with a baseline cough count of ≥25 awake coughs per
hour are expected to be randomized across four arms (1:1:1:1)
evaluating the three active doses and placebo in the main study.
Treatment arms will be stratified by baseline awake cough frequency
to help balance the baseline cough count across trial arms. The
primary efficacy endpoint will be the placebo-adjusted change in
the 24-hour cough frequency using a cough recorder in the main
study. An additional 40 participants with a baseline cough count
<25 awake 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 an exploratory
analysis.
The trial is expected to enroll participants in approximately
100 sites, including 50 centers in the United States. The first
patient is expected to be dosed in Q4 2020.
An interim analysis is expected to be conducted once 50% of
patients have completed the main study and is anticipated in
mid-2021. Using a predefined probability of efficacy hurdle,
results from the interim analysis may be used to help select
dose(s) for Phase 3 and initiate Phase 3 planning, including health
authority interactions. Topline results from SOOTHE are expected in
2H 2021.
The Company has confirmed a meeting with FDA in Q4 2020 and any
adjustments to trial design or our expected timeline based on FDA
feedback will be disclosed thereafter.
Learnings from RELIEF Phase 2 Data
The previous Phase 2 RELIEF trial indicated a significant
interaction between baseline cough frequency and the response to
BLU-5937. Pre-specified analyses regarding the impact of baseline
cough frequency on treatment effect, including subgroup analyses in
participants with baseline awake cough frequency of ≥20 coughs/hour
and ≥32 coughs/hour (median), revealed statistically significant
and clinically meaningful reductions in cough frequency relative to
placebo:
- Patients with ≥20 coughs/hour (80% of trial patients) saw
placebo adjusted reduction in awake cough frequency of 20%
(p=0.001), 18% (p=0.02), 19% (p=0.03) and 27% (p=0.003) at doses of
25, 50, 100 and 200 mg BID respectively.
- Patients above the median with ≥32 coughs/hour at baseline (50%
of trial patients) saw placebo adjusted reduction in awake cough
frequency of 28%, 28%, 30% and 32% (all p< 0.0015) at doses of
25, 50, 100 and 200 mg BID respectively.
- A statistically significant relationship (p=0.0258) was
observed between average awake cough frequency at baseline and
treatment effect, linking increased baseline cough frequency with
improved treatment benefit.
“The SOOTHE Phase 2b trial represents a significant milestone
for BELLUS and patients suffering from refractory chronic cough,”
said Roberto Bellini, President and CEO of BELLUS Health. "We
believe we have optimized our clinical strategy based on the RELIEF
trial results and are excited about initiating the SOOTHE Phase 2b
trial later this year.”
About the Phase 2 RELIEF Trial
RELIEF was a randomized, placebo-controlled, two-period
crossover, dose-escalation study to assess the efficacy, safety and
tolerability of BLU-5937, a highly selective P2X3 antagonist, at
four doses: 25, 50, 100 and 200 mg, administered orally,
twice-daily. RELIEF enrolled a total of 68 refractory chronic cough
patients from 16 sites in the United Kingdom and United States.
Further details on the RELIEF trial design and results can be found
at on the Company’s website.
About BLU-5937
BLU-5937, a highly selective P2X3 antagonist - (>1500 fold) -
is in development for chronic cough, chronic pruritus and other
hypersensitization-related disorders.
The P2X3 receptor in the cough reflex pathway, which is
implicated in chronic cough, 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 chronic cough while maintaining taste
function through targeted inhibition of P2X3 receptors rather than
P2X2/3 receptors which play a major role in taste.
In addition to chronic cough and chronic pruritus, BLU-5937 may
also have broad applicability across other afferent
hypersensitization-related disorders, enabling the Company to
consider developing a pipeline of therapies using its P2X3
platform. BELLUS Health is exploring how P2X3 activation can
contribute to irritation and pain, and whether inhibition of P2X3
receptors can help treat these afferent hypersensitization-related
disorders.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company
developing novel therapeutics for the treatment of chronic cough
and other hypersensitization-related disorders. The Company's
product candidate, BLU-5937, is being developed for the treatment
of chronic cough and chronic pruritus.
Chronic cough, the lead indication for BLU-5937, is a cough
lasting more than eight weeks and is associated with significant
adverse physical, social and psychosocial effects on health and
quality of life. It is estimated that approximately 26 million
adults in the United States suffer from chronic cough with
approximately 3 million having refractory chronic cough lasting for
more than a year and approximately 6 million having refractory
chronic cough lasting more than 8 weeks and under one year. There
is no specific therapy approved for refractory chronic cough and
current treatment options are limited.
Chronic pruritus, commonly known as chronic itch, is an
irritating sensation that leads to scratching, and persists for
longer than six weeks, which can be debilitating and has a
significant impact on quality-of-life. It is a hallmark of many
conditions, including atopic dermatitis (AD). It is estimated that
chronic pruritus associated with AD affects more than 16.9 million
adults in the United States.
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 design, timing and outcome of its Phase
2b trial of BLU-5937 in refractory chronic cough, including with
respect to design, timing and benefits of the interim analysis, the
timing of initiation and topline results and the benefits of
recruiting patients with a higher baseline cough count, the timing
and outcome of interactions with FDA and other health authorities,
the timing and outcome of Phase 3 planning, 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 its clinical development plan, the potential
tolerability profile, selectivity and other characteristics of
BLU-5937 as compared to other competitor candidates 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:
feedback from FDA and other health authorities on clinical trial
design, dose selection and indication, 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, 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 product candidates. 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/20200908005354/en/
Danny Matthews Director, Investor Relations and Communications
danny@bellushealth.com
BELLUS Health (TSX:BLU)
Historical Stock Chart
From Mar 2024 to Apr 2024
BELLUS Health (TSX:BLU)
Historical Stock Chart
From Apr 2023 to Apr 2024