Vanderbilt University’s data provides further confirmation that PBI-4050 markedly inhibits the development of renal fibrosis.
- PBI-4050 protects against renal fibrosis and improves pancreatic function in Type 2 Diabetes db/db mouse model.
- Excellent safety and tolerability profile in humans without adverse events presented.
LAVAL, QUEBEC, CANADA, – November 9, 2015 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF)
(“ProMetic” or the “Corporation”) disclosed today that its lead drug candidate, PBI-4050 and follow-on analogues, were the object of 7 presentations during the American Society of Nephrology (ASN) annual meeting in San Diego, California.
Kidney fibrosis occurs in chronic kidney diseases and leads to gradual loss of kidney function. Although the etiology of kidney fibrosis is multifactorial, there is increasing evidence linking chronic inflammation to progressive kidney fibrosis.
Dr. Ray Harris and Dr. Ming-Zhi Zhang of Vanderbilt University reported: “The Activation of epidermal growth factor receptor (EGFR) contributes to the development of renal fibrosis. We have developed a transgenic mouse model in which overexpression of an EGFR receptor in the renal proximal tubules leads to tubulointerstitial fibrosis by 3-4 weeks of age. In this new mouse model, PBI-4050 markedly inhibits the development of renal fibrosis”.
Dr. Lyne Gagnon, Vice-President, Preclinical R&D at ProMetic, presented data in a gold standard Type 2 diabetes animal model demonstrating that PBI-4050 improves hyperglycemia, preserves insulin production and β-cell function and survival, and prevents renal fibrosis in parallel with regulation of profibrotic biomarkers.
Dr. John Moran, ProMetic’s Chief Medical Officer, commented “While the efficacy results in renal fibrosis and diabetes animal models are very impressive, let’s not forget the importance of the phase 1 and Phase 1b clinical data generated so far, and the fact that PBI-4050 is extremely well tolerated in humans. Moreover, our pharmacokinetic studies confirm that we do not need to adjust the dosing in patients with impaired renal function, another very favourable outcome”.
Poster: Phase 1 and 1b Studies of PBI-4050, a Novel Anti-Fibrotic Agent for Chronic Kidney Disease
“PBI-4050 has also been confirmed to be safe and well tolerated in the first 12 patients enrolled in our study of Type 2 diabetes and metabolic syndrome”, commented Pierre Laurin, ProMetic’s President and CEO. “This Canadian study was also designed to detect early signs of improvement in the metabolic status of these patients and in doing so demonstrate that the very promising results observed in preclinical models translate to humans. The Corporation expects to provide preliminary results on the effect of PBI-4050 on metabolic disorders in type 2 diabetic patients by year-end”, added Mr. Laurin.
More data has been presented during the American Society of Nephrology (ASN) annual meeting in San Diego, California, and the posters can be found on ProMetic’s website under the following presentation titles:
More on 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,heart, lungs and liver. Twenty six million patients in the U.S. alone are diagnosed with chronic kidney diseases (“CKD”). Patients with severe CKD stages (3 and 4) suffer from a gradual and accelerated loss of their renal function (end-stage renal disease or ESRD) leading to the need for hemodialysis. Cardiovascular complications for ESRD patients on hemodialysis are a common cause of death.
About ProMetic Life Sciences Inc.
ProMetic Life Sciences Inc. (prometic.com) is an established biopharmaceutical company with globally recognized expertise in bioseparation, 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 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, 2014, 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.