- No Taste Loss at the Anticipated
Therapeutic Doses -
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
announced positive top-line results from the clinical Phase 1 study
for BLU-5937, its lead drug candidate for the treatment of chronic
cough.
The Phase 1 top-line data demonstrated that
BLU-5937 has a good safety and tolerability profile, as well as a
pharmacokinetic profile supporting twice-a-day (BID) dosing. At the
anticipated therapeutic doses of 50 to 100 mg, BLU-5937 did not
cause any loss of taste perception; only 1 out of 24 subjects
reported transient taste alteration. Based on these data, the
Company intends to advance BLU-5937 into a clinical Phase 2 study
in chronic cough patients beginning in mid-2019.
“We are very pleased with the results of the
clinical Phase 1 study which show compelling safety, tolerability
and pharmacokinetics for BLU-5937,” said Dr. Denis Garceau, Senior
Vice President, Drug Development of BELLUS Health. “The clinical
data confirm our expectation that at the anticipated therapeutic
doses there is no or very limited effect on taste perception and
further reinforce our position that BLU-5937 has the potential to
be a best-in-class therapeutic for chronic cough patients. We
believe the Phase 1 data provide strong support for our planned
clinical Phase 2 study for BLU-5937, which we expect to initiate in
mid-2019.”
“I am very enthusiastic about these positive
top-line Phase 1 results for BLU-5937,” commented 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 Chair of
BELLUS Health’s Clinical Advisory Board. “The compelling product
profile and none to minimal side effects on taste perception seen
in this first-in-human study should greatly benefit chronic cough
patients. This sets the stage for the further development of
BLU-5937 and I look forward to continue working on the program,
including as Principal Investigator for the Phase 2 study in
chronic cough patients.”
BLU-5937 Clinical Phase 1 Study
Data
The Phase 1 data demonstrated that BLU-5937 has
an excellent pharmacokinetic profile. Plasma half-life was
established at approximately 5 hours, supporting BID dosing. Based
on pre-clinical efficacy studies and comparison with drug levels
achieved with a clinically validated comparator, the Company
anticipates that drug levels required for optimal inhibition of
cough will be achieved at 50 mg or 100 mg BID.
BLU-5937 plasma concentration increased
dose-proportionally and was not affected by food, supporting
BLU-5937 administration without regard to meals.
The Phase 1 data also showed that BLU-5937 has a
good safety and tolerability profile. The overall incidence of
adverse events was comparable between placebo (56%) and BLU-5937
(47%).
There were no serious adverse events and no
subjects withdrew prematurely due to an adverse event during the
study. No significant trends of mean changes in vital signs,
electrocardiogram (ECG) and clinical laboratory values have been
observed in the Phase 1 study for BLU-5937.
No subject reported total loss of taste at any
dose level. Only one subject out of 24 (4.2%) reported taste
alteration at the anticipated therapeutic doses of 50-100 mg. This
taste effect was reported only on the first day out of 7 days of
dosing in a subject receiving 100 mg BID. At supra-therapeutic
doses of 200 mg to 1200 mg, two subjects out of 48 (4.2%) reported
mild, transient partial loss of taste and 13 subjects out of 48
(27.1%) reported taste alteration. No subject out of 16 reported
any taste loss or taste alteration at 200 mg. All taste adverse
events were transitory and sporadic in nature and almost all of
them were mild. The other most frequent adverse events reported in
the Phase 1 study (> 5%) for BLU-5937 were: headache (12.5%),
numbness (11.1%), nausea (8.3%), dizziness (8.3%) and heartburn
(5.6%).
BLU-5937 Clinical Phase 1
Study
The clinical Phase 1 study was a randomized,
double-blind, placebo-controlled study of orally administered
BLU-5937 in 90 healthy adult subjects. The primary objectives of
the clinical Phase 1 study were to assess the safety, tolerability
(including taste perception) and pharmacokinetic profile of
BLU-5937 in healthy subjects.
The study was divided in two parts:
Part 1: A single ascending doses (SAD) study was
conducted in 60 healthy subjects. Subjects were randomized into 6
cohorts of 10 subjects (8 BLU-5937: 2 placebo). The study evaluated
single oral doses of BLU-5937 from 50 to 1200 mg.
Part 2: A multiple ascending doses (MAD) study
was conducted in 30 healthy subjects. Subjects were randomized into
3 cohorts of 10 subjects (8 BLU-5937: 2 placebo). The study
evaluated multiple oral doses of BLU-5937 of 100, 200 and 400 mg
administered twice-a-day (BID) for 7 consecutive days.
BLU-5937 Clinical Phase 2 Study
Design
Based on the positive top-line data from the
Phase 1 study, BELLUS Health expects to initiate a clinical Phase 2
study for BLU-5937 in chronic cough patients in mid-2019, with
top-line results anticipated in mid-2020. This will be a dose
escalation crossover design study to assess the safety,
tolerability and efficacy of BLU-5937 in chronic cough patients, in
addition to helping confirm the optimal dose regimen. A total of 50
patients with refractory unexplained chronic cough are expected to
be enrolled in approximately 10 clinical sites located in the
United Kingdom and Unites States.
Conference Call Details
BELLUS Health will host a conference call and
live webcast tomorrow, November 20 at 8:00 am ET to discuss the
results of the Phase 1 study and to provide an update on the
upcoming development efforts of BLU-5937 for the treatment of
chronic cough, including the Phase 2 study design.
The conference call and live webcast can be
accessed as follows:
Domestic (US): 1-888-224-1121
International: 1-323-794-2575Conference ID: 9549357Live webcast
(with slides):
https://viavid.webcasts.com/starthere.jsp?ei=1221461&tp_key=d49788a767
Following the event, the archived webcast and
BELLUS Health’s presentation will be available on the Company’s
website at www.bellushealth.com. The webcast will be archived for 1
year after the event.
About BLU-5937 for Chronic
Cough
BLU-5937 is a potent, highly selective, orally
bioavailable small molecule antagonist of the P2X3 receptor, a
clinically validated target for chronic cough. BLU-5937 has the
potential to be a best-in-class therapeutic for chronic cough
patients who do not respond to current therapies.
In preclinical studies, BLU-5937 exhibited an
excellent safety profile and a potent anti-tussive effect without
affecting taste perception.
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 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.
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.
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.
FOR MORE INFORMATION, PLEASE CONTACT:
François DesjardinsVice President, Finance
450-680-4525fdesjardins@bellushealth.com
SOURCE: BELLUS Health Inc.
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