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news.ProMetic Life Sciences has reported that its small molecule lead compound PBI-4050 has been approved to commence clinical trials in patients suffering from Diabetic Kidney Disease (DKD) following the CTA clearance by Health Canada.
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In the initial phase of the clinical program scheduled to commence this month, eight (8) DKD patients will be enrolled. The objectives of this double blind, placebo controlled, multi-dose study are to demonstrate the safety and tolerability of PBI-4050 and to compare the pharmacokinetic profile of the drug in DKD patients with severely impaired kidney function to that demonstrated in healthy volunteers.
"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", commented Dr. John Moran, Chief Medical Officer of ProMetic, "This cohort will complete our pharmacokinetic studies and will serve to define the doses we will use in the follow-on phase II studies", added Dr. Moran.
This short study will immediately be followed by a placebo-controlled multicentre trial in DKD patients. The Corporation also expects to initiate a clinical program this quarter in patients suffering from Idiopathic Pulmonary Fibrosis.
"The acceptance of our Clinical Trial Application by Health Canada represents an important milestone in the PBI-4050 clinical development program", said Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic.
"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", added Mr. Laurin.