- Data from Ongoing Phase 1 Study for Lead
Drug Candidate BLU-5937 Expected in Q4 2018 -
LAVAL, QC, Aug. 8, 2018 /CNW/ - BELLUS Health Inc.
(TSX: BLU) ("BELLUS Health" or the "Company"), a clinical-stage
biopharmaceutical company developing novel therapeutics for
conditions with high unmet medical need, today reported its
financial and operating results for the second quarter ended
June 30, 2018. All currency figures
reported in this press release are in Canadian dollars, unless
otherwise specified.
Recent Highlights
- In July 2018, initiated a Phase 1
clinical study for BLU-5937, its lead drug candidate for the
treatment of chronic cough, in healthy subjects; results are
expected in the fourth quarter of 2018;
- Completed all Clinical Trial Application ("CTA")-enabling
preclinical studies for BLU-5937, including preclinical toxicology
studies demonstrating the compound's excellent safety profile;
- Secured patent protection for BLU-5937 in all major
pharmaceutical markets; patents were granted by the European Patent
Office and the Japan Patent Office in 2018 in addition to patents
granted in the United States and
China in 2017, with claims
covering the composition of matter of BLU-5937 until 2034;
- Concluded the quarter with cash, cash equivalents and
short-term investments totalling $20.2
million, which should be sufficient to finance the Company's
operations for more than two years.
"We are proud of the significant progress we have made over the
last year in the development of our lead drug candidate BLU-5937
for chronic cough, having reached a significant development
milestone in July with the initiation of our first-in-human study",
said Roberto Bellini, President and
CEO of BELLUS Health. "We believe BLU-5937 has the characteristics
to be a best in class P2X3 antagonist for chronic cough, and now
look forward to the Phase 1 results, expected in the fourth quarter
of 2018."
BLU-5937 for Chronic Cough
On July 9, 2018, the Company
initiated a Phase 1 clinical study for BLU-5937 in healthy
subjects. The main objectives of the Phase 1 clinical study are to
assess the safety, tolerability (including taste perception) and
pharmacokinetic profile of BLU-5937. This is a randomized,
double-blind, placebo-controlled study of orally administered
BLU-5937 in up to 90 healthy adult subjects.
The study is divided in two parts: a single-ascending dose
("SAD") study, which is being conducted in up to 60 healthy
subjects, and a multiple-ascending dose ("MAD") study, which will
be conducted in up to 30 healthy subjects.
Results of the Phase 1 clinical study are expected in the fourth
quarter of 2018. These results will help define BLU-5937's expected
product profile, including the safety, tolerability (including
taste perception) and dosing regimen for the Phase 2
proof-of-concept study.
The Phase 2 proof-of-concept study is expected to be initiated
in 2019 in chronic cough patients. This will be a dose escalation
study to assess the safety, tolerability and efficacy of
BLU-5937.
Preclinical studies demonstrated that BLU-5937 is a highly
selective P2X3 antagonist exhibiting a potent anti-tussive effect
without affecting taste perception and an excellent safety profile.
In a guinea pig cough model, BLU-5937 showed comparable
anti-tussive efficacy to the current leading P2X3 antagonist in
development, Merck & Co's gefapixant (also named AF-219 or
MK-7264). In a rat taste model, BLU-5937 was not associated with
taste loss whereas, consistent with clinical trial data previously
presented by Merck & Co, gefapixant led to significant taste
loss.
On July 19, 2018, the Company
announced that patent protection for BLU-5937 had been secured in
all major pharmaceutical markets following the Japan Patent
Office's issuance of a decision to grant a patent with claims
covering the composition of matter of BLU-5937 and related
imidazopyridine compounds, in addition to pharmaceutical
compositions comprising BLU-5937 and uses thereof. Equivalent
patents with similar broad claims were issued by the European
Patent Office in April 2018 and by
the U.S. Patent and Trademark Office and the Chinese Patent Office
in 2017. The patents have an expiration date of 2034.
Other Development Programs
Information on the Company's other partnered development
programs – KIACTA™ for sarcoidosis, AMO-01 for Phelan McDermid syndrome and ALZ-801 for APOE4
homozygous Alzheimer's disease – can be found on the Company's
website at www.bellushealth.com.
Summary of Financial Results
|
|
|
|
Three months
ended
June 30,
2018
|
Three months
ended
June 30,
2017
|
|
(in thousands of
dollars, except per share data)
|
Revenues
|
$
|
8
|
$
|
41
|
Research and
development expenses, net
|
|
(881)
|
|
(1,084)
|
General and
administrative expenses
|
|
(946)
|
|
(541)
|
Net finance
income
|
|
84
|
|
3
|
Change in fair value
of contingent consideration
|
|
|
|
|
|
receivable
|
|
171
|
|
—
|
Realized gain on sale
of available-for-sale
|
|
|
|
|
|
investment in FB
Health
|
|
—
|
|
1,909
|
Deferred tax
expense
|
|
—
|
|
(61)
|
Net (loss) income for
the period
|
|
(1,564)
|
|
267
|
Basic and diluted
(loss) earnings per share
|
$
|
(0.01)
|
$
|
—
|
- Research and development expenses, net of research tax credits,
amounted to $881,000 for the
three-month period ended June 30,
2018, compared to $1,084,000
for the corresponding period the previous year. The decrease is
attributable to lower expenses incurred during the quarter in
relation to the development of BLU-5937, during which the Company
completed all necessary preclinical studies on BLU-5937 in
preparation to the Phase 1 clinical study, which was initiated in
July 2018.
- General and administrative expenses amounted to $946,000 for the three-month period ended
June 30, 2018, compared to
$541,000 for the corresponding period
the previous year. The increase is mainly due to higher stock-based
compensation expense in relation to the Company's stock option plan
and deferred share unit plans.
- Net finance income amounted to $84,000 for the three-month period ended
June 30, 2018, compared to
$3,000 for the corresponding period
the previous year. The increase is primarily attributable to higher
interest income due to the Company's increased cash, cash
equivalents and short-term investments position ("liquidity
position") following the equity offering in December 2017.
- Change in fair value of contingent consideration receivable
amounted to $171,000 for the
three-month period ended June 30,
2018, compared to nil for the corresponding period the
previous year. The contingent consideration receivable is related
to the sale of the Company's equity interest in FB Health S.p.A
("FB Health") in June 2017.
- Realized gain on sale of available-for-sale investment in FB
Health amounted to nil for the three-month period ended
June 30, 2018, compared to
$1,909,000 for the corresponding
period the previous year, and is related to the sale of the equity
interest in FB Health in 2017.
As at June 30, 2018, the Company
had available cash, cash equivalents and short-term investments
totalling $20,247,000, compared to
$23,888,000 as at December 31, 2017. Based on management's estimate
and current level of operations, the Company believes that the
current liquidity position is sufficient to finance its operations
for more than two years.
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, 2018 will be available shortly on SEDAR
at www.sedar.com and on the Company's website at
www.bellushealth.com.
About BELLUS Health (www.bellushealth.com)
BELLUS Health is a clinical-stage biopharmaceutical company
developing novel therapeutics for conditions with high unmet
medical need. Its pipeline of projects includes the Company's lead
drug candidate BLU-5937 for chronic cough and several other
partnered clinical-stage drug development programs. BLU-5937, a
highly selective P2X3 antagonist, has the potential to be a
best-in-class therapeutic for chronic cough patients who do not
respond to current therapies.
Chronic cough is a cough that lasts more than eight weeks and is
associated with significant adverse social, psychosocial and
physical effects on quality of life. A recent commercial assessment
performed by Torreya Insights on behalf of the Company concluded
that, in the United States alone,
more than 26 million adults have chronic cough and more than
2.6 million of these patients suffer from refractory chronic cough
lasting for more than a year.
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. 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 Inc.'s control. Such risks factors include but
are not limited to: the ability to expand and develop its project
pipeline, the ability to obtain financing, the impact of general
economic conditions, general conditions in the pharmaceutical
industry, changes in the regulatory environment in the
jurisdictions in which BELLUS Health Inc. does business, 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 pre-clinical and clinical trial milestones 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 Inc.'s drug candidates' development
process, their market size and commercial value, as well as the
sharing of proceeds between BELLUS Health Inc. and its potential
partners from potential future revenues, if any, are dependent upon
a number of factors. Consequently, actual future results and events
may differ materially from the anticipated results and events
expressed in the forward-looking statements. BELLUS Health Inc.
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 Inc. 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 Inc.'s public
filings with the Canadian securities regulatory authorities,
including the Annual Information Form, for further risk factors
that might affect BELLUS Health Inc. and its business.
SOURCE BELLUS Health Inc.