» Statistically and clinically significant decrease of glycated hemoglobin (HbA1c) at 12 weeks in an open label study
» Significant improvement in physical parameters related to metabolic syndrome (waist circumference, body weight and body mass index)
» Robust study results support proof of concept
» Open label study to transition to a placebo-controlled pivotal phase II study in type 2 diabetes patients
» Confirmation of PBI-4050’s safety profile and dose for upcoming pivotal studies
LAVAL, QUEBEC, CANADA – December 1, 2015 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) announced today that it has decided to close patient enrollment in its phase II open label study in patients suffering from type 2 diabetes and metabolic syndrome and will transition to a pivotal placebo-controlled phase II study in patients suffering from type 2 diabetes.
This decision is based on the statistically and clinically significant decrease in HbA1C observed in the first 11 patients enrolled that have completed 12 weeks in the study. Ten of the 11 patients experienced improved blood glucose control as measured by HbA1C (average decrease of -0.6 p=0.03), a decrease that compares favorably to other drugs already approved for the treatment of diabetes.
“The primary objectives of this open label study were to confirm the safety and tolerability of PBI-4050 in this patient population, and to look for early evidence of pharmacological activity in humans”, stated Dr. John Moran, Chief Medical Officer of ProMetic. “We now have clear evidence that the drug’s unique mode of action and related efficacy observed in diabetic animal models translate to humans. It is important to note that these patients still had elevated HbA1c values despite treatment with standard oral antidiabetic medications, making this improvement in HbA1C very impressive indeed. To date there have been no drug-related Serious Adverse Events and PBI-4050 has been very well tolerated by patients. Moreover, we also observed that the PBI-4050 treatment reduced waist circumference, body weight and body mass index (BMI), that is, there is a striking improvement in the physical parameters related to metabolic syndrome. With the exception of studies in ultra-rare conditions such as the one being pursued in Europe, our upcoming clinical trials are pivotal in nature and therfore will be placebo-controlled”.
Dr. Peter Senior, Professor of Medicine and Director of the Department of Endocrinology at the University of Alberta, the principal investigator for the clinical trial commented: “This drug may be of benefit for people with Type 2 diabetes because it has a different mode of action and avoids some undesired side effects seen with many of the drugs currently used, such as weight gain or hypoglycemia. I am excited that ProMetic is proceeding to a randomized placebo-controlled study”.
The Corporation will be supplementing its forthcoming filings with the FDA with the recent clinical information gathered in the Canadian trials. ProMetic intends to file INDs for PBI-4050 with the FDA for patients with Type 2 diabetes & CKD as well as patients with Idiopathic Pulmonary Fibrosis (IPF).
“With these positive results in diabetic patients, we also intend to pursue an additional orphan indication with PBI-4050 to be announced shortly”, commented Pierre Laurin, Chief Executive Officer of ProMetic, who added: “We expect PBI-4050 to perform especially well in patients affected by both diabetes and progressive fibrotic diseases”.
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 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 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, cancer and autoimmune diseases/inflammation. A number of both the plasma-derived and small molecule products are under development for orphan drug indications. 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.
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ProMetic Life Sciences Inc
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ProMetic Life Sciences Inc.