ProMetic Life Sciences‘ PBI-4050 compound has been approved to be used in clinical trials for patients suffering with Diabetic Kidney Disease (DKD) following CTA clearance by Health Canada.
The clinical program is scheduled to start this month and the initial phase will enroll eight patients with DKD. This is a double blinded, placebo controlled and multi-dose trial to assess the safety and tolerability of the PBI-4050 molecule. The clinical trial also aims to compare PBI-4050’s pharmacokinetic profile in DKD patients with severely impaired kidney function to the profile of healthy volunteers.
Dr. John Moran, Chief Medical Officer of ProMetic commented in a press release: “Based on our extensive preclinical studies, we do not expect to see a difference in the pharmacokinetics of PBI-4050 DKD patients when compared to healthy volunteers. (…) This cohort will complete our pharmacokinetic studies and will serve to define the doses we will use in the follow-on phase II studies.”
This study will be proceeded immediately by a placebo-controlled multi center trial in diabetic kidney disease patients and ProMetic also expects to initiate a clinical program this quarter to test the compound in Idiopathic Pulmonary Fibrosis.
The President and Chief Executive Officer of ProMetic, Pierre Laurin, said: “The acceptance of our Clinical Trial Application by Health Canada represents an important milestone in the PBI-4050 clinical development program (…) PBI-4050 shows great promise in diabetic patients with kidney diseases, as well as for orphan medical conditions where diabetes and/or fibrosis co-exists and affect key organs such as the liver, heart and lungs. We anticipate to shortly disclose one additional orphan indication targeted by PBI-4050.”
ProMetic is a globally recognized expert in bioseparations, small-molecule drug development and plasma-derived therapeutics. The company uses its own highly efficient technology to extract and purify therapeutic proteins from human plasma and develop best-in-class therapeutics. It is an active company in developing novel therapeutics to respond to the unmet medical needs in fibrosis, cancer, anemia, neutropenia, autoimmune disease/inflammation and nephropathies.