- New results from additional patients increase statistical and clinical evidence of efficacy.
- Reduction of glycated hemoglobin (HbA1c) reaches -0.9% (p=0.0004) in patients with HbA1c ≥ 8% at baseline
- PBI-4050 continues to improve other physical parameters related to metabolic syndrome (waist circumference, body weight and body mass index)
LAVAL, QUEBEC, CANADA, – April 26, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) announced today that new data including an additional nine patients enrolled in its PBI-4050 phase 2 open label study in patients suffering from type 2 diabetes and metabolic syndrome confirms the efficacy initially reported in the first 11 patients that had completed the treatment period in December, 2015. In these additional nine patients, administration of PBI-4050 resulted in similar pharmacological activity on the diabetic and metabolic parameters, including the decrease in HbA1c as was shown in the original 11 patients.
Dr. Moran, ProMetic’s Chief Medical Officer explained: “This ongoing clinical study enabled us to confirm that PBI-4050 can be safely added to a cocktail of antihyperglycemic drugs in diabetic patients with elevated HbA1c. With results now available from twenty patients, we are also able to see the effect in a larger number of patients with elevated HbA1c levels of > 7.5% or even ≥ 8%, which is the typical inclusion criterion of other diabetic drug clinical trials. In the thirteen patients enrolled with an HbA1c > 7.5%, we observed an average decrease of -0.75% (p=0.0004). This average decrease was -0.9% in seven patients with HbA1c levels of ≥ 8% (p=0.0004). These results compare very favorably with commercially available antidiabetic drugs. We have clear evidence that PBI-4050 provides significant benefit when added to routine therapy with oral antidiabetic agents”, concluded Dr. Moran.
A recent and comprehensive review of randomized controlled clinical trials involving 24,163 patients that studied the effect of commercially approved antihyperglycemic drugs, DPP-4 inhibitors, on HbA1c reported an average reduction of -0.77%, with a mean baseline HbA1c value of 8%.
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 continues to demonstrate a consistent efficacy and safety profile in patients with Type 2 diabetes. We also noticed that the level of HbA1c rose in most patients within one month after completing the study’s course and ceasing to receive PBI-4050. This rise of HbA1c after “washout” is strong evidence of a true benefit of PBI-4050”.
“PBI-4050’s reduction of HbA1c in our open label trial is a very strong efficacy signal that provides us with very valuable insight for the placebo controlled clinical trial design in patients with Chronic Kidney Disease with diabetes and in patients with metabolic syndrome and diabetes”, commented Pierre Laurin, CEO of ProMetic. “We are very confident about the prospect of PBI-4050’s clinical performance in the other on-going clinical trials and the placebo controlled studies we are initiating”, added Mr. Laurin.
The Corporation previously disclosed the clinical programs of PBI-4050 to include placebo controlled studies in patients with cystic fibrosis and related diabetes, patients with chronic kidney disease and diabetes, patients with scleroderma and patients with idiopathic pulmonary fibrosis. Further updates on the various PBI-4050 clinical programs will be provided during the forthcoming Annual Meeting of Shareholders to be held on May 11, 2016.
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, 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.