-Team of Internationally-Renowned Cough
Experts to Guide BLU-5937 Clinical Development Strategy-
LAVAL, QC, Sept. 25, 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
announced the appointment of a world-class clinical advisory board
("CAB"). The CAB will provide strategic guidance and support to the
development of BLU-5937, BELLUS Health's lead drug candidate for
chronic cough, as the Company prepares for a clinical Phase 2
study. BLU-5937 is currently in a clinical Phase 1 study and
results are expected in the fourth quarter of 2018. The first
meeting of the CAB was held on September
24 in London, United
Kingdom.
"We are thrilled to welcome this team of highly respected
clinician leaders whose work has deeply influenced the treatment
and management of chronic cough," said Dr. Denis Garceau, Senior Vice President, Drug
Development of BELLUS Health. "Their background and expertise will
be invaluable to the clinical development of our lead drug
candidate BLU-5937 as we prepare for a Phase 2 study, expected to
be initiated in 2019. In addition to helping BELLUS Health navigate
the regulatory aspects of drug development, this team of
accomplished scientific and clinical experts will help guide our
goal of bringing this potential best-in-class therapeutic for
chronic cough to patients."
The CAB members are:
- Dr. Jaclyn Smith, MB, ChB, FRCP, PhD, Chair of the CAB, is a
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.
She leads a multi-disciplinary research team whose focus is on
understanding mechanisms underlying pathological cough and runs a
regional clinical service for patients with refractory chronic
cough. Dr. Smith is also the Director of the NIHR Manchester
Clinical Research Facility. In collaboration with Mr. Kevin McGuinness (Clinical engineer), she has
developed a novel method for automated cough detection.
- Dr. Alan Goldsobel, MD, is a
practising allergist and immunologist, a Clinical Professor of
Medicine at the University of California, San
Francisco and an Adjunct Clinical Professor of Pediatrics at
Stanford University Medical School. He
is also a Fellow of the American Academy of Allergy, Asthma &
Immunology and past president of the California Society of Allergy,
Asthma & Immunology. Dr. Goldsobel is co-director of the
Allergy and Asthma Clinical Research Center in San Jose, CA where he has served as principal
investigator for clinical trials of many of the new therapeutic
agents for chronic refractory cough. He has published numerous
scientific articles and book chapters in allergy and asthma and his
area of interest, cough.
- Dr. Lorcan McGarvey, MD, FRCP,
is a Consultant Respiratory Physician and Professor of Respiratory
Medicine at Queen's University of Belfast, Northern Ireland. His main programme
of research has focused on the clinical and scientific aspects of
acute and chronic cough. Dr. McGarvey has been a core contributor
to the British Thoracic Society and European Respiratory Society
cough guidelines and serves on the American College of Chest
Physicians Cough Guidelines Expert Committee.
- Dr. Alyn Morice, MD, is a
Professor of Respiratory Medicine, Head of Medicine, Hull York
Medical School, University of Hull in the United Kingdom. He specialises in the
diagnosis and treatment of cough and runs the Hull Cough Clinic,
the first UK Cough Clinic which he established in 1989 and which
has become the largest centre within Europe with an international pattern of
referral. Professor Morice has led the European Respiratory Society
and British Thoracic Society Taskforces on Cough. He also runs the
Hull Respiratory Clinical Trials Unit specialising in the treatment
of the airways diseases associated with cough.
- Dr. Mandel Sher, MD, is a
community-based clinician of pediatric and adult allergy,
University of South Florida's Clinical
Professor and former Interim Division Chief of Allergy and
Immunology of University of South
Florida located at Johns
Hopkins/All Children's Hospital. With a unique sub-specialty
in Refractory/ Recalcitrant/Idiopathic chronic cough, Dr. Sher
established the Center for Cough in Florida in 2009, which combines existing
evidence-based approaches with innovative therapeutic modalities to
improve chronic cough patients' clinical outcomes.
"BELLUS Health is focused on developing BLU-5937 with the goal
of bringing a clinically meaningful treatment to chronic cough
patients who are in need of a new therapeutic option," commented
Dr. Jaclyn Smith, Chair of the CAB.
"I am looking forward to working closely with BELLUS Health's
management team and my esteemed colleagues on the CAB to realize
the full potential of BLU-5937."
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.
In July 2018, BELLUS Health
initiated a clinical Phase 1 study for BLU-5937 in healthy
subjects. Results are expected in the fourth quarter of 2018. A
clinical Phase 2 study is expected to be initiated in 2019 in
chronic cough patients.
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 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.
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.
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
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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
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SOURCE BELLUS Health Inc.