Prometic confirms PBI-4050’s anti-fibrotic effect in NASH model and on human hepatic stellate cells

April 14, 2016 Fred Dumais
  • Down regulation of fibrotic biomarkers in human hepatic stellate cells (HHSC); key cells involved in liver fibrosis.
  • PBI-4050 significantly reduces liver fibrosis in NASH model.

LAVAL, QUEBEC, CANADA, – April 14, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) presented today new data at the 2016 European Association for the Study of the Liver (EASL)’s 51st Annual Meeting – The International Liver Congress (ILC) in Spain.

The new data confirms that PBI-4050’s anti-fibrotic effect demonstrated in the livers of different animal models has been successfully reproduced in human hepatic stellate cells (“HHSC”) during in vitro preclinical experiments designed to simulate fibrogenesis in the liver. PBI-4050 was found to down-regulate key pro-fibrotic biomarkers considered to be driving the fibrotic process in NASH.

Dr. Lyne Gagnon, Vice-President, R&D, Preclinical of ProMetic commented: “It is exciting to see that the anti-fibrotic activity of PBI-4050 observed in a NASH animal model correlates with the down-regulation of fibrotic markers in human HHSC activation, where HHSC is considered as a key player in the fibrogenic process of the liver. It is also very important to note that all key fibrosis biomarkers such as CTFG and αSMA were also down-regulated to their normal respective levels”, added Dr. Gagnon.

“We continue to build evidence that PBI-4050 works on human cells in a predictable way, entirely in agreement with what we see in standard animal models of fibrosis,” stated Dr John Moran, Chief Medical Officer of ProMetic. “This new data follows evidence of efficacy in human kidney and skin cells, and of course our recent statistically significant clinical results in patients with metabolic syndrome and type 2 diabetes. Going forward we will be monitoring very closely the effect of PBI-4050 on the liver, which is an organ particularly affected in patients suffering from Alström syndrome or cystic fibrosis, as well as many more common disease entities.”

ProMetic will present two posters at the International Liver Congress; one on its lead clinical drug candidate, PBI-4050, and the other on a follow on compound, PBI-4425, entitled:

PBI-4050 Decreases Hepatic Stellate Cell Activation and Ameliorates Fibrosis in Carbon Tetrachloride (CCl4)-Induced Hepatic Fibrosis Model (Presentation #405)
Sarra-Bournet, B. Grouix, K. Hince, A. Felton, M. Tremblay, S. Abbott, J.-S. Duceppe, B. Zacharie, P. Laurin, and L. Gagnon

Oral Treatment with PBI-4425 Decreases Fibrosis in Carbon Tetrachloride (CCl4)-Induced Hepatic Fibrosis Model (Presentation #281)
Grouix, F. Sarra-Bournet, K. Hince, A. Felton, M. Tremblay, S. Abbott, J.-S. Duceppe, B. Zacharie, P. Laurin, and L. Gagnon


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 patients in the U.S. alone are believed to suffer from chronic kidney diseases (“CKD”). Patients 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. ( 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, 2015, 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.

About the Author

Fred Dumais

Fred is responsible for leading Prometic’s investor relations team and is accountable for all global investor relations activity, PR and event management. He joined the company in 2001, and brings nearly twenty years of experience in investor and financial communications, as well as a deep experience of the pharmaceutical industry. He has extensive knowledge of the global financial markets in the US, Europe and his native country of Canada. Fred is a graduate from Concordia University where he gained a BA in Business Communications. He also brings to the role a background in law with a LLB from the University of Québec.

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