Phase 2 clinical trial to commence in Q2 2016 as planned
LAVAL, QUEBEC, CANADA – May 18, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) today reported that it had been approved to commence the clinical trial of its orally active anti-fibrotic lead drug candidate, PBI-4050, in patients suffering from cystic fibrosis (“CF”), following the CTA clearance by Health Canada. The objectives of this 24 week randomized, double-blind, and placebo-controlled Phase 2 study includes the evaluation of the effects of PBI-4050 on pancreatic and lung function in 90 CF patients.
As a result of significantly improved standards of care over the past decades, the average life expectancy for CF patients now exceeds 40 years. However, with a longer life expectancy, the genetic condition also generates serious pancreatic and hepatic complications. In particular, 70% of CF patients will have abnormal glucose tolerance, and 35-40% of adult CF patients will develop a unique type of diabetes, a condition known as cystic fibrosis-related diabetes (“CFRD”). CFRD is associated with all the complications typical of diabetes, leading to progressive eye, kidney, peripheral nerve, and gastrointestinal tract damage. Patients with CFRD have worse lung function, poorer nutrition, more frequent hospitalization, and higher mortality rates than those affected by CF but without diabetes.
“It is well-known that CF adversely affects lung function. However there is very often co-existing pancreatic damage, leading not only to decreased production of digestive enzymes and malabsorption of food but also to impaired glucose tolerance and to frank diabetes” stated Dr John Moran, Chief Medical Officer of ProMetic. “We have already demonstrated a significant
improvement in the blood glucose levels in patients with metabolic syndrome with Type 2 diabetes treated with PBI-4050, and a significant reduction of fibrosis in the lungs, pancreas and liver in multiple animal models. We believe that the unique mode of action of PBI-4050 could indeed provide much relief for the CF patients by reducing the level of fibrosis in their lungs and pancreas and by improving the production of insulin” concluded Dr. Moran.
Mr. Pierre Laurin, CEO of PLI commented: “We are very excited to commence this trial in cystic fibrosis patients who have benefited over the years from a myriad of medical interventions leading to a progressively improved life expectancy. While the primary objective in this study is to identify if we can defer or reduce the use of insulin treatment in these patients, our hope here is that the reduction of fibrosis observed in the lungs, pancreas and liver in preclinical studies translates to a further improvement in their quality of life and life expectancy”.
ProMetic has recently reported a statistically and clinically significant decrease in HbA1C levels that compares very favorably to drugs already approved and marketed for the treatment of diabetes as well as additional evidence of PBI-4050’s pharmacological and clinical activity in humans based on the analysis of new pro-inflammatory biomarkers in blood and urine samples from these patients. These results clearly indicate that the drug’s unique mode of action and related efficacy observed in diabetic animal models translate to humans. To date there have been no drug-related Serious Adverse Events and PBI-4050 has been very well tolerated by patients.
More on CF and CFRD
Cystic fibrosis (CF), also known as mucoviscidosis, is a life-threatening, genetic disease that affects especially the lungs but also the pancreas, liver, kidneys, and gut. Long-term issues include difficulty breathing and frequent lung infections, with long-term impairment of lung function.
In people with CF, a defective gene causes a buildup of thick mucus in the lungs, pancreas and other organs. In the lungs, the mucus clogs the airways and traps bacteria leading to infections, extensive lung damage and eventually, respiratory failure. In the pancreas, the mucus prevents the release of digestive enzymes that allow the body to break down food and absorb vital nutrients.
The pancreas contains the islets of Langerhans, which are responsible for making insulin, an anabolic hormone that regulates blood glucose. Damage to the pancreas can lead to loss of the islet cells, leading to a type of diabetes that is unique to those with the disease. This cystic fibrosis-related diabetes (“CFRD”) shares characteristics that can be found in regular type 1 and type 2 diabetics, and is one of the principal non-pulmonary CF related complications.
CFRD increases in prevalence with increasing age, and is becoming more common as the life expectancy of patients with CF improves, and is now the most common non-respiratory complication of CF. People with CFRD have lower lung function, worse nutrition, more frequent hospitalization, and worse mortality than CF people without diabetes.
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. (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.