- Phase 2b Trial Design for BLU-5937 in
Refractory Chronic Cough to be Announced in Q3 2020 -
BELLUS Health Inc. (Nasdaq:BLU; TSX:BLU) (“BELLUS Health” or the
“Company”), a clinical-stage biopharmaceutical company developing
novel therapeutics for the treatment of chronic cough and other
hypersensitization-related disorders, today reported its financial
and operating results for the second quarter ended June 30,
2020.
PROGRAM AND CORPORATE HIGHLIGHTS
Announced topline results from the Phase 2 RELIEF clinical
trial of BLU-5937 in patients with refractory chronic cough in July
2020.
- While the primary endpoint of placebo-adjusted reduction in
awake cough frequency was not achieved, a numerical difference in
favor of BLU-5937 was observed at all doses.
- A pre-specified analysis of high cough frequency (≥median)
patients achieved highly statistically significant (p<0.0015)
and clinically meaningful reductions (28-32%) in placebo-adjusted
awake cough frequency at all doses.
- Results showed that BLU-5937 was well tolerated, with taste
disturbance events reported by fewer than 10% of patients receiving
BLU-5937 and an overall safety profile similar to placebo.
- Additional data from the Phase 2 RELIEF clinical trial of
BLU-5937 in patients with refractory chronic cough will be
presented at upcoming respiratory conferences.
Expects to initiate an adaptive Phase 2b trial of BLU-5937
enriched for higher cough count patients in the fourth
quarter of 2020.
- The Company expects to provide the Phase 2b trial design in the
third quarter of 2020 and plans to have a meeting with the U.S.
Food and Drug Administration (“FDA”) prior to trial initiation in
the fourth quarter of 2020.
“Our Phase 2 RELIEF trial, including the reduction in cough
frequency observed in patients with higher cough counts in addition
to the low taste effect, support advancing the study of BLU-5937,”
said Roberto Bellini, President and Chief Executive Officer of
BELLUS Health. “We look forward to initiating our Phase 2b trial
enriched for higher cough count patients by year end following
regulatory feedback from the FDA in the fourth quarter of this
year.”
FINANCIAL RESULTS
Cash Position: As of June 30, 2020, the Company had
available cash, cash equivalents and short-term investments
totaling US$74.0 million, compared to US$90.0 million at December
31, 2019.
Net Loss: For the second quarter ended June 30, 2020, net
loss amounted to US$8,422,000 (US$0.14 per share), compared to
US$5,909,000 (US$0.13 per share) for the same period in 2019.
Research and Development Expenses: Research and
development expenses, net of research tax credits, amounted to
US$5,899,000 for the second quarter ended June 30, 2020, compared
to US$4,100,000 for the same period in 2019. The increase is
primarily attributable to higher expenses incurred in relation to
the development of BLU-5937, mainly activities in relation to the
Phase 2 RELIEF trial in refractory chronic cough, for which topline
results were announced on July 6, 2020.
General and Administrative Expenses: General and
administrative expenses amounted to US$3,439,000 for the second
quarter ended June 30, 2020, compared to US$1,771,000 for the same
period in 2019. The increase is mainly due to increased general and
administrative costs incurred since the Company’s Nasdaq listing in
September 2019 and higher stock-based compensation expense in
relation to its stock option plan.
Net Finance Income (Costs): Net finance income amounted
to US$912,000 for the second quarter ended June 30, 2020, compared
to net finance costs of US$44,000 for the same period in 2019. The
increase in net finance income is mainly attributable to a foreign
exchange gain that arose from the translation of the Company’s net
monetary assets denominated in Canadian dollars during the
quarter.
The Company’s full unaudited condensed consolidated interim
financial statements and accompanying management’s discussion and
analysis for the three and six-month periods ended June 30, 2020
will be available shortly on SEDAR at www.sedar.com and on EDGAR at
www.sec.gov/edgar.
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 by not inhibiting 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. It is
estimated that approximately 55% of patients have mild disease, and
approximately 45% have moderate to severe disease. 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 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 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 timing and outcome of future
regulatory interactions and timing and design of future trials for
its chronic cough program, 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: 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.
SUMMARY OF FINANCIAL RESULTS
Three months ended June 30,
2020
Three months ended June 30,
2019
(in thousands of dollars, except
per share data)
Revenues
US$
4
US$
6
Research and development expenses, net
(5,899
)
(4,100
)
General and administrative expenses
(3,439
)
(1,771
)
Net finance income (costs)
912
(44
)
Net loss for the period
US$
(8,422
)
US$
(5,909
)
Basic and diluted loss per share
US$
(0.14
)
US$
(0.13
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200813005222/en/
Danny Matthews Director, Investor Relations and Communications
danny@bellushealth.com
BELLUS Health (TSX:BLU)
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