Primary efficacy endpoint statistically
significant with 34% placebo-adjusted reduction in 24-hour cough
frequency observed at 50 mg and 200 mg BID doses (p ≤ 0.005)
BLU-5937 was well-tolerated with a low rate of
taste-related adverse events (≤6.5%); treatment emergent adverse
event profile comparable to placebo
Company also provides an update on its P2X3
pipeline and BLU-5937 Phase 2a trial for the treatment of chronic
pruritus
Company to host conference call and webcast at
8:00 a.m. ET
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
(“RCC”) and other hypersensitization-related disorders, today
announced that the 50 mg and 200 mg BID doses of BLU-5937 in its
Phase 2b SOOTHE trial for the treatment of RCC achieved statistical
significance on the primary endpoint with 34% placebo-adjusted
reduction in 24-hour cough frequency observed (p ≤ 0.005) at day
28. BLU-5937 was generally well-tolerated, with low rates of
taste-related adverse events reported (≤6.5%) at all doses.
Mr. Roberto Bellini, Chief Executive Officer of BELLUS Health
commented, “We are extremely pleased with the compelling topline
results from the Phase 2b SOOTHE trial which highlight BLU-5937’s
best-in-class potential for the treatment of refractory chronic
cough. RCC is a prevalent and growing condition that significantly
impacts the quality of life of an estimated 9 million patients in
the United States and 9 million patients in Europe.”
Summary of Topline Results: Phase 2b
SOOTHE Trial in Refractory Chronic Cough
Efficacy Results:
The SOOTHE trial, which enrolled 249 participants with a
baseline awake cough frequency of ≥ 25 per hour, demonstrated a
clinically meaningful and statistically significant
placebo-adjusted reduction in 24-hour cough frequency of 34% at the
50 mg and 200 mg BID dose levels of BLU-5937 (p ≤ 0.005) at day 28.
The 12.5 mg BID dose demonstrated a statistical trend with 21%
reduction in placebo-adjusted 24-hour cough frequency (p=0.098)
with a dose response observed between the 12.5 mg and 50 mg BID
doses.
SOOTHE Primary Efficacy Endpoint
Dose
Placebo-adjusted change in 24-hour cough
frequency at day 28
p-value
12.5 mg BID
-21.1
%
p=0.098
50 mg BID
-34.4
%
p=0.003
200 mg BID
-34.2
%
p=0.005
Safety and Tolerability Results:
BLU-5937’s safety and tolerability data were consistent with
previous trials, including the Phase 2a RELIEF trial. BLU-5937 was
well-tolerated with low impact on taste perception. Taste-related
side effects were infrequent at all dose levels with taste
alteration observed in 4.8%, 6.5% and 4.8% of participants at 12.5
mg BID, 50 mg BID and 200 mg BID, respectively. No participant
reported complete or partial taste loss and there were no
discontinuations due to taste-related adverse events.
The treatment emergent adverse event profile was comparable to
placebo. There were no treatment emergent serious adverse events
reported in the trial.
Next Steps:
The Company intends to request an End of Phase 2 meeting with
the FDA that is expected to take place in 2Q 2022 to discuss the
Phase 3 program which is expected to start in 2H 2022.
“With no specific treatments approved for refractory chronic
cough, patients and physicians struggle to manage this condition
that significantly impacts the quality of life of those afflicted.
The SOOTHE trial topline results generated from this large,
multicenter, controlled trial are truly exciting because the
impressive efficacy and tolerability profile observed for BLU-5937
could significantly benefit refractory chronic cough patients,”
said Dr. Jaclyn Smith, Professor of Respiratory Medicine at the
University of Manchester in the United Kingdom and an Honorary
Consultant at the University Hospital of South Manchester NHS
Foundation Trust, and Principal Investigator of the Phase 2b SOOTHE
trial.
Dr. Catherine Bonuccelli, Chief Medical Officer of BELLUS Health
added, “The Phase 2b SOOTHE topline results demonstrated an
important treatment benefit of BLU-5937 and its potentially
best-in-class tolerability profile, with low taste-related side
effects observed. We look forward to incorporating the SOOTHE
results into our accelerated planning for Phase 3 with the
objective of bringing this treatment option to patients with
refractory chronic cough as efficiently as possible.”
Update on P2X3 Pipeline
Summary of Topline Results: Phase 2a Proof-of-Concept BLUEPRINT
Trial in Chronic Pruritus
In the Phase 2a proof-of-concept BLUEPRINT trial in patients
with chronic pruritus associated with atopic dermatitis (“AD”),
BLU-5937 (200 mg BID) did not achieve statistical significance for
the primary endpoint of placebo-adjusted reduction in weekly mean
Worst Itch-Numeric Rating Scale (“WI-NRS”). BLU-5937 was
well-tolerated and the treatment emergent adverse event profile was
comparable to placebo. The Company does not intend to further
pursue development of BLU-5937 in pruritic conditions.
P2X3 Pipeline
The success of the Phase 2b SOOTHE trial further validates the
role of P2X3 in cough hypersensitivity. The Company intends to
evaluate potential opportunities to study BLU-5937 in additional
cough indications where cough hypersensitivity plays an important
role.
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 chronic pruritus
associated with AD. More information about the trial is available
at www.clinicaltrials.gov: NCT04693195.
Conference Call & Webcast Information:
The Company will host a conference call and webcast to discuss
the topline results from the Phase 2b SOOTHE trial on December 13,
2021 at 8:00 a.m. ET.
Individuals can participate in the conference call by dialing
877-405-1224 (domestic) or 201-389-0848 (international) and
referring to the “BELLUS Phase 2b SOOTHE Trial Topline Results.”
The live webcast of the event may be accessed through the Events
and Presentations page of BELLUS Health’s website, under the
Investors & News section.
The archived webcast will be available for replay on the BELLUS
Health website after the event.
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, has successfully completed a Phase 2b trial in
RCC and is planning a Phase 3 program that is expected to begin in
2022.
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.
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 design,
timing and results of its Phase 2b SOOTHE clinical trial of
BLU-5937 in RCC, 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
timing of initiation of its Phase 3 clinical trial of BLU-5937 in
RCC, the commercial potential of BLU-5937, including with respect
to patient population, pricing and labeling, BELLUS Health’s
intention to discontinue development of BLU-5937 in pruritic
conditions and the Phase 2a proof-of-concept BLUEPRINT trial,
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 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, 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 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/20211213005297/en/
FOR MORE INFORMATION: Ramzi Benamar Chief Financial
Officer rbenamar@bellushealth.com
Media: Brad Miles Solebury Trout
bmiles@soleburytrout.com
Immucor, Inc. (MM) (NASDAQ:BLUD)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Immucor, Inc. (MM) (NASDAQ:BLUD)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024