- Statistically significant decrease in novel biomarkers associated with a high risk of cardiovascular events
- Results further support PBI-4050’s pharmacological activity and clinical benefits in patients
LAVAL, QUEBEC, CANADA – March 22, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) announced today that the preliminary analysis of new pro-inflammatory biomarkers in blood and urine samples from the patients in the on-going, open label, Phase 2, metabolic syndrome and Type 2 diabetes clinical trial provides additional evidence of PBI-4050’s pharmacological and clinical activity in humans.
Last December, the Corporation reported the statistically and clinically significant decrease in HbA1C observed in the first 11 patients enrolled who had completed the 12 week study. Overall the patients experienced improved blood glucose control as measured by HbA1C (average decrease of -0.6% p=0.03), with 10 of the 11 experiencing a decrease in HbA1c. In patients with HbA1c values greater than 7.5% at screening, this decrease in HbA1c exceeded 1%, a performance that compares very favorably to drugs already approved for the treatment of diabetes.
Analyses of novel biomarkers in all 11 patients has revealed that elevated levels of specific biomarkers known to be associated with a higher risk of cardiovascular events were significantly reduced by PBI-4050. Blood levels of resistin and pentraxin-3, two biomarkers known to be associated with higher risk of cardiovascular complications in patients with metabolic syndrome, were significantly reduced by PBI-4050 (p = 0.01). Furthermore, IL-18, a biomarker known to be associated with renal as well as cardiovascular complications in patients with the metabolic syndrome, also showed a statistically significant reduction (p = 0.05).
“This additional data provides additional evidence of PBI-4050’s pharmacological activity in humans”, stated Dr. John Moran, Chief Medical Officer of ProMetic. “We were of course impressed with the improvement in HbA1c when PBI-4050 was added to standard oral antidiabetic medications. We now have evidence that the drug may provide additional clinical benefit by protecting the kidney and heart. Moreover, PBI-4050 has demonstrated a very good safety and tolerability profile, with no drug-related Serious Adverse Events.”
“We expect PBI-4050 to perform as well in patients with chronic conditions with an underlying progressive fibrotic process”, commented Pierre Laurin, President and Chief Executive Officer of ProMetic, who added: “Our clinical program including patients affected with Alström Syndrome, scleroderma, cystic fibrosis, lung fibrosis and chronic kidney disease is designed to leverage PBI-4050’s outstanding performance in multiple preclinical models of either diabetes or fibrosis or both and this most recent positive data in patients with Type 2 diabetes and metabolic syndrome”.
The Corporation will be supplementing its forthcoming filings with the FDA and Health Canada with the recent clinical information gathered in the Canadian trials. ProMetic intends to file INDs for PBI-4050 with the FDA for patients with CKD & Type 2 diabetes as well as patients with Idiopathic Pulmonary Fibrosis (IPF) and with Health Canada for patients with metabolic syndrome & Type 2 diabetes, cystic fibrosis and scleroderma.
ProMetic will discuss in greater details PBI-4050’s positive effects on the novel biomarkers, the addition of scleroderma to PBI-4050’s targeted indications and the plasminogen phase II/III clinical trial during its fourth quarter and 2015 year-end financial results conference call/webcast scheduled for 11:00am (ET) on Thursday March 31, 2016. The telephone numbers to access the conference call are 647-427-7450 and 1-888-231-8191. A live audio webcast of the conference call will be available via this link.
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 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. (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, 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.