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Prometic's PBI-4050 Shown to Reduce Liver Damage and Fibrosis in High-Fat Diet Induced Obesity and Metabolic Syndrome Mouse Model
Date:4/20/2017

LAVAL, QC, April 20, 2017 /PRNewswire/ - Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) ("Prometic" or the "Corporation") today presented new results at the International Liver Congress ("ILC") 2017 of the European Association for the Study of the Liver ("EASL") in Amsterdam on the positive effects of PBI-4050 on reduction of non-alcoholic steatohepatitis (NASH) in a mouse model of obesity and metabolic syndrome.

According to Dr. Lyne Gagnon, Vice-President of R&D Pre-clinical of Prometic "This extensive preclinical study enabled us to further characterize the effects of PBI-4050 on metabolic regulation and white adipose tissue and liver fibrosis induced in a high fat diet model. As such, PBI-4050 effectively reduced liver damage and fibrosis, improved insulin resistance (HOMA-IR) and the pancreatic ß-cells function (HOMA-ß).  Furthermore, pro-fibrotic and fibrotic gene expression in liver and in white adipose tissue were reduced with PBI-4050 treatment", added Dr. Gagnon.

"These results strongly correlate with those seen in our Phase 2 clinical trials in diabetes associated with metabolic syndrome and Alström syndrome", stated John Moran, Prometic's Chief Medical Officer. "Prometic is advancing PBI-4547 in the clinical stage in H2 2017, a PBI-4050 analogue that is showing even better results in NASH models at a much lower dose. This provides us with the ability to eventually position different drug candidates for different indications", added Dr. Moran.

Overall, 38 percent of U.S. adults and 17 percent of teenagers are obese. The Trust for America's Health projects that 44 percent of Americans will be obese by 2030. Obesity is associated with an increased risk of non-alcoholic fatty liver disease. Steatosis, the hallmark feature of NAFLD, occurs when the rate of hepatic fatty acid uptake from plasma and de novo fatty acid synthesis is greater than the rate of fatty acid oxidation and export (as triglyceride within very low-density lipoprotein). Therefore, an excessive amount of intrahepatic triglyceride represents an imbalance between complex interactions of metabolic events. The presence of steatosis is associated with a constellation of adverse alterations in glucose, fatty acid, and lipoprotein metabolism. It is likely that abnormalities in fatty acid metabolism, in conjunction with adipose tissue, hepatic, and systemic inflammation, are key factors involved in the development of insulin resistance, dyslipidemia, and other cardiometabolic risk factors associated with NASH. 

Poster presentation at the conference:

Dr Grouix, Thursday April 20, 2017, 8:00 AM – 6:00 PM:

PBI-4050 reduces liver damage and fibrosis in a High-Fat diet mouse model of obesity and metabolic syndrome.

More about NAFLD/NASH:

NAFLD is a condition defined by excessive fat accumulation in the form of triglycerides (steatosis) in the liver. A subgroup of NAFLD patients displays liver cell injury and inflammation in addition to excessive fat (steatohepatitis). The latter condition, designated NASH, is virtually indistinguishable histologically from alcoholic steatohepatitis (ASH).

More about PBI-4050

PBI-4050 is an orally active lead drug candidate with excellent safety and efficacy profiles confirmed in several in vivo experiments targeting fibrosis. Fibrosis is a very complex process by which continuing inflammation causes vital organs to lose their function as normal tissue is replaced by fibrotic scar tissue. The proof of concept data generated to date confirms our lead drug candidates' anti-fibrotic activity in several key organs including the kidneys, the heart, the lungs and the liver. Twenty-six million subjects in the U.S. alone are believed to suffer from chronic kidney diseases ("CKD"). Subjects with severe CKD stages (3 and 4) suffer from a progressive loss of their renal function leading to end-stage renal disease and the need for dialysis or kidney transplant. Cardiovascular complications are the most common cause of death in dialysis patients.

About Prometic Life Sciences Inc.       

Prometic Life Sciences Inc. (www.prometic.com) is a long established biopharmaceutical company with globally recognized expertise in bioseparations, plasma-derived therapeutics and small-molecule drug development. Prometic offers its state of the art technologies for large-scale purification of biologics, drug development, proteomics and the elimination of pathogens to a growing base of industry leaders and uses its own affinity technology that provides for highly efficient extraction and purification of therapeutic proteins from human plasma in order to develop best-in-class therapeutics and orphan drugs. Prometic is also active in developing its own novel small-molecule therapeutic products targeting unmet medical needs in the field of fibrosis, anemia, neutropenia, cancer and autoimmune diseases/inflammation as well as certain nephropathies. Headquartered in Laval (Canada), Prometic has R&D facilities in the UK, the U.S. and Canada, manufacturing facilities in the UK and commercial activities in the U.S., Canada, Europe, Russia, Asia and Australia.

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, 2016, 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.

                                            


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