-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.
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.
For further information: François Desjardins, Vice President, Finance, 450-680-4525, [email protected]