PROMETIC RECEIVES CLEARANCE FROM HEALTH CANADA TO PROCEED WITH ITS PBI-4050 PLACEBO-CONTROLLED PHASE 2 CLINICAL TRIAL IN PATIENTS WITH METABOLIC SYNDROME AND TYPE 2 DIABETES
'November 16, 2016 – ProMetic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (“ProMetic” or the “Corporation”) today reported that it has received clearance by Health Canada to commence a placebo-controlled phase 2 clinical trial with its PBI-4050, the company’s orally active, lead small molecule anti-fibrosis drug candidate, in patients with metabolic syndrome and type 2 diabetes.
The objectives of this 12 week randomized, double-blind, placebo-controlled, multi-center, 4 arm with 67 patients per arm (1 placebo, 3 escalating doses) phase 2 clinical trial includes the evaluation of the effects of PBI-4050 on metabolic syndrome parameters and on pro-inflammatory/fibrotic and diabetic biomarkers in the blood and urine. The phase 2 clinical trial is expected to commence in Q4 2016.
ProMetic has recently reported data from its completed open label Phase 2 clinical trial in patients with metabolic syndrome and type 2 diabetes where PBI-4050 (800 mg) was administered once daily to 24 patients for a period of 12 weeks, and for an additional 12 weeks to 10 patients. The data collected confirmed the achievement of the clinical trial primary and secondary endpoints. The pharmacological activity of PBI-4050 was confirmed through the clinically significant reduction in HbA1c observed between the date of screening and Week 12; a reduction that was maintained at 24 week. Several biomarkers measured in the blood or urine of patients and associated with a high incidence of cardiovascular complications and kidney injuries when found to be elevated in metabolic syndrome patients were significantly reduced by PBI-4050.
Mr. Pierre Laurin, CEO of ProMetic commented: “We are very excited to quickly move to the placebo controlled portion of our metabolic syndrome and type 2 diabetes clinical program. Based on the level of clinical efficacy observed in the open label portion of the program, we are very confident in the ability of PBI-4050 to replicate the same significant reduction in key metabolic parameters in a placebo controlled clinical trial environment”.
More data from the open label phase 2 clinical trial will be disclosed during the forthcoming annual meeting of the American Society of Nephrology in Chicago (Nov. 18) and at the Corporation’s Analyst Day scheduled for November 21 in NYC.
More on Metabolic Syndrome
Metabolic syndrome is a major risk factor for cardiovascular disease and for Type 2 diabetes, and consists of the constellation of central (truncal) obesity, high blood triglycerides, low HDL (“good”) cholesterol, elevated blood pressure, and elevated blood glucose. Obesity is believed to cause a chronic inflammatory state, which leads to insulin resistance and so may in turn result in cardiovascular disease and/or Type 2 diabetes. Given the global epidemic of obesity, both in the developed and developing world, the metabolic syndrome and its consequences present a devastating public health problem. It is difficult to grasp the numbers and the overwhelming public health issues presented by the global epidemic of obesity, the metabolic syndrome, and Type 2 diabetes. The International Diabetes Federation estimates that in 2013 there were 300 million diabetics world-wide, and that that number will increase to 600 million by the year 2035. The Centers for Disease Control estimates that 34% of US adults have the metabolic syndrome, and that 1 of 3 children born in the U.S. during the year 2000 will develop diabetes during their lifetime.
More on 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.'
Jim |
