ProMetic completes PBI-4050 Phase I clinical trial

ProMetic’s PBI-4050 was found to be safe and very well tolerated without any serious adverse events reported in any of the 5 cohorts tested.

The objectives of this oral, double blind, placebo controlled, single ascending dose study were to demonstrate the safety and tolerability of PBI-4050 and to establish the pharmacokinetic profile of the drug candidate at different doses.

The study design also included a component looking at food effect on drug absorption. The trial was conducted in 5 cohorts of 8 subjects. In each cohort, 6 subjects received PBI-4050 and 2 subjects received matching placebo.

"This bodes very well for the clinical program as the therapeutic dose is expected to be at the low end of the range tested in this clinical trial", commented Dr John Moran, Chief Medical Officer of ProMetic, "With this excellent safety profile, we can now test this very promising drug candidate in patients".

Dr. Lyne Gagnon stated, "This study also confirms that PBI-4050 does not appear to have any bioavailability concerns following oral administration. The absorption and elimination of PBI-4050 in humans is similar to that observed in preclinical models".

"PBI-4050 is now set to move into clinical development in diabetic patients with kidney diseases, as well as other orphan medical conditions where diabetes and/or fibrosis is affecting key organs such as liver, kidney, heart and lungs. We will disclose such selected additional indications over the coming months", said Mr. Pierre Laurin, President and Chief Executive Officer of ProMetic.

PBI-4050 is an orally active lead drug candidate with efficacy and excellent safety 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 gradually 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.