LAVAL, QUEBEC, CANADA, – September 5, 2018 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“Prometic”) reported today that it will host a Key Opinion Leader meeting on PBI-4050, a novel treatment for Alström Syndrome (AS) and a promising therapeutics candidate for the treatment of non-alcoholic steatohepatitis (NASH) on Friday, September 7th in New York City.
The meeting will feature presentations by Key Opinion Leaders (KOLs) Manal F. Abdelmalek, MD, MPH (Duke University School of Medicine), and Patrick Colin, BPharm, PhD (PCC Inc.), who will discuss the current treatment landscape, clinical development pipeline, and unmet medical need for treating patients with Alström Syndrome (AS) and the Metabolic Syndrome associated conditions non-alcoholic fatty liver disease (NAFLD) and NASH. Both KOLs will be available to answer questions at the conclusion of the event.
Prometic's management team will provide an overview of their clinical asset PBI-4050 for patients with AS, which is currently being studied in a phase 2 clinical trial. PBI-4050 has been granted a Rare Pediatric Disease Designation by the FDA, an Orphan Drug Designation by the FDA and the EMA for the treatments of AS and idiopathic pulmonary fibrosis (IPF) as well as a PIM (Promising Innovative Medicine) designation by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of IPF and AS.
Manal Abdelmalek, MD, MPH is a Professor of Medicine in the Department of Gastroenterology at Duke University School of Medicine in Durham, North Carolina. Dr. Abdelmalek’s research interests include metabolic liver disease, particularly obesity-related liver disease and its association with complications of the insulin resistance syndrome. She is interested in studying the clinical, environmental, and genetic risk factors for nonalcoholic fatty liver disease (NAFLD), new therapeutic options for treatment, and evaluating the impact of NAFLD and NASH from a public health perspective. She was a Fellow in Gastroenterology, Medicine, at the Mayo School of Health Sciences between 1995 and 1998. She obtained her M.D degree at the University of Missouri in Kansas City in 1992. She has an extensive clinical drug development experience in the field of NASH.
Dr. Colin’s credentials include 32 years of global drug development experience, and more than 15 market approvals (of which 12 were related to GI and hepatology) in the US, EU and Canada. Patrick Colin graduated from the Faculty of Pharmacy at the University of Montreal, where he obtained both a professional Pharmacy degree (B.Pharm.) as well as a Ph.D. in Pharmaceutical Sciences. Dr. Colin is currently the founder and president of PCC Inc., a GI-Hepatology oriented drug development consulting firm. He was previously Chief Development Officer at Verlyx Pharma, a Montreal-based biotech specialized in the treatment of liver disease. He is also the co-founder of Gicare Pharma and Laurent Pharma, two Canadian biotechs specialized in Gastroenterology and Cystic Fibrosis, respectively. He also spent more than 12 years at Axcan Pharma, a Canadian GI-focused pharmaceutical firm, where he established and led the drug development department as the Vice-President, R&D. Finally, Dr. Colin has been an invited lecturer at the Faculty of Pharmacy, University of Montreal, for almost two decades. He teaches various subjects related to clinical drug development, to the students of the Biopharmaceutical Sciences first cycle program (BSBP), as well as the Specialized Studies Diploma in Drug Development (DESS).
This event is intended for institutional investors, sell-side analysts, investment bankers, and business development professionals only. Please RSVP in advance if you plan to attend, as space is limited. For those who are unable to attend in person, a live webcast and replay will be available here (http://lifesci.rampard.com/20180907b/reg.jsp). If you would like to ask a question during the live Q&A, please submit your request via the email.
More about Alström syndrome:
Alström syndrome is a rare inherited autosomal recessive syndrome characterized by the onset of obesity in childhood or adolescence, Type 2 diabetes, often with severe insulin resistance, dyslipidemia, hypertension and severe multi-organ fibrosis involving the liver, kidney and heart. Alström syndrome is also characterized by a progressive loss of vision and hearing, a form of heart disease that weakens the heart muscle (dilated cardiomyopathy), and short stature. This disorder can also cause serious or life-threatening medical problems involving the liver, kidneys, bladder, and lungs. The clinical manifestations of Alström syndrome vary in severity, and not all affected individuals have all of the features associated with the disorder.
More about PBI-4050
PBI-4050 is an orally active lead drug candidate with excellent safety and efficacy profiles demonstrated in a large number of animal models of fibrosis affecting different organs, including the lung, liver, heart, kidney, and pancreas. The effects of PBI-4050 demonstrated in animal models have been replicated in Phase 2 studies in idiopathic pulmonary fibrosis (IPF), in metabolic syndrome with type 2 diabetes and in Alström syndrome. PBI-4050 is entering pivotal placebo-controlled Phase 3 clinical trials for the treatment of IPF and has already begun placebo-controlled Phase 2 trials in metabolic syndrome and type 2 diabetes patients.
About Prometic Life Sciences Inc.
Prometic (www.prometic.com) is a publicly traded (TSX symbol: PLI) (OTCQX symbol: PFSCF) biopharmaceutical corporation with two drug discovery platforms focusing on unmet medical needs. The first platform (small molecule therapeutics) stems from the discovery of two receptors which we believe are at the core of how the body heals: namely, promoting tissue regeneration and scar resolution as opposed to fibrosis. One of the lead drug candidates emerging from this platform, PBI-4050, is expected to enter pivotal phase 3 clinical trials for the treatment of Idiopathic Pulmonary Fibrosis (IPF). The second drug discovery and development platform (plasma-derived therapeutics) leverages Prometic’s experience in bioseparation technologies used to isolate and purify biopharmaceuticals from human plasma. The Corporation’s primary goal with respect to this second platform is to address unmet medical needs with therapeutic proteins not currently commercially available, such as Ryplazim™ (plasminogen). We are also leveraging this platform’s higher recovery yield potential to advance established plasma-derived therapeutics such as Intravenous Immunoglobulin (IVIG). Furthermore, the Corporation is continuing to secure its plasma supply through the execution of third party contracts and expansion of its own collection activities for its plasma processing needs. The Corporation also provides access to its proprietary bioseparation technologies to enable pharmaceutical companies in their production of non-competing biopharmaceuticals. Recognized as a bioseparations expert, the Corporation derives revenue from this activity through sales of affinity chromatography media which contributes to offset the costs of its own R&D investments.
We are headquartered in Laval, Quebec (Canada) and have R&D facilities in Canada, the United Kingdom (“UK”) and the United States (“USA”), manufacturing facilities in Canada and the Isle of Man and corporate and business development activities in Canada, the USA, and Europe.
Forward Looking Statements
This press release contains forward-looking statements about Prometic’s objectives, strategies and businesses that involve risks and uncertainties. These statements are “forward-looking” because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Such risks and assumptions include, but are not limited to, Prometic’s ability to develop, manufacture, and successfully commercialize value-added pharmaceutical products, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the ability of Prometic to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. You will find a more detailed assessment of the risks that could cause actual events or results to materially differ from our current expectations in Prometic’s Annual Information Form for the year ended December 31, 2017 under the heading “Risk and Uncertainties related to Prometic’s business”. As a result, we cannot guarantee that any forward-looking statement will materialize. We assume no obligation to update any forward-looking statement even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations. All amounts are in Canadian dollars unless indicated otherwise.
For further information please contact:
President and CEO
Prometic Life Sciences Inc.
Senior Director, Communications & Investor Relations
Prometic Life Sciences Inc.
Matt Middleman, M.D.
LifeSci Public Relations