A Summary of New Data Presented:
- PBI-4050 significantly reduced microparticles shedding from the kidney and key renal biomarkers in diabetic and obese patients
- PBI-4050 prevents diabetic nephropathy and damage to pancreatic cells producing insulin in preclinical diabetic model
- PBI-4050 reduces liver damage and insulin resistance in a high fat diet preclinical model
- New data presented at the American Diabetes Association’s 77th Scientific Sessions in San Diego
LAVAL, Quebec – June 12, 2017 – Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) presented new data at the 2017 American Diabetes Association (ADA)’s 77th Scientific Sessions in San Diego. The data presented included results from a Phase 2 clinical trial evaluating PBI-4050 in 24 patients with metabolic syndrome and type 2 diabetes (MST2D), as well as from preclinical studies demonstrating the protective effect of PBI-4050 on the kidney, pancreas and liver in diabetic animals.
New data from the completed Phase 2 trial, discussed in an oral presentation, showed that, after 12 weeks of treatment with PBI-4050, a statistically significant reduction of microparticles shedding from the kidney in the patients’ urine was observed. Furthermore, a statistically significant reduction in key renal biomarkers was also demonstrated in the same patients. “Taken together, these data provide strong evidence that PBI-4050 protects the kidney from the injury commonly observed in diabetic patients,” explained John Moran, M.D., Chief Medical Officer at Prometic. “This is supportive of our Phase 2/3 placebo-controlled clinical trial we intend to initiate in the second half of 2017 in patients with late stage chronic kidney disease and diabetes”.
Lyne Gagnon, Ph.D., Vice President of Research and Development at Prometic presented data providing further evidence that the beneficial clinical effect of PBI-4050 is through a novel mechanism regulating inflammation and fibrosis. “It is quite compelling to see how PBI-4050 reduces damages in the liver, kidney and pancreas in two new preclinical models which again translates perfectly to what we have observed in the patients in our clinical trial,” stated Dr. Gagnon.
Oral presentation and posters at ADA:
About PBI-4050 & PBI-4547
PBI-4050 and PBI-4547 are Prometic’s orally active lead drug candidates targeting fibrosis. PBI-4050 will be entering Phase 2/3 clinical trials after demonstrating efficacy and excellent safety profiles in three Phase 2 open label clinical trials. Prometic plans to initiate the next phase of clinical trials for PBI-4547 in the fourth quarter of 2017. Fibrosis is a 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 with PBI-4050 confirms its anti-fibrotic activity in several key organs including the kidneys, the heart, the lungs and the liver. PBI-4050 has on-going clinical trials in patients with metabolic syndrome and type 2 diabetes, cystic fibrosis with related diabetes and Alström Syndrome. The planned Phase 2/3 clinical trials scheduled to commence this year target patients with idiopathic pulmonary fibrosis (IPF) and chronic kidney disease (CKD). Twenty-six million patients in the U.S. alone are believed to suffer from 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 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 number of industry leaders. The company uses its own affinity technology, which provides for highly efficient extraction and purification of therapeutic proteins from human plasma, 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 fields 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 U.K., the U.S. and Canada, manufacturing facilities in the U.K. 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, 2016, 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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