LAVAL, QC – Health Canada has given ProMetic Life Sciences clearance to commence its placebo-controlled Phase 2 clinical trial with its lead small molecule anti-fibrosis drug candidate, PBI-4050, in patients with metabolic syndrome and type 2 diabetes.
The objectives of the 12 week randomized, double-blind, placebo-controlled, multi-center, four 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.