ProMetic completes Phase Ib trial of PBI-4050 in CKD patients

In the randomized, double-blind, placebo-controlled, multi-dose trial, PBI-4050 was found to be safe and well tolerated without any serious adverse events reported.

The trial’s objectives were to show the safety and tolerability of PBI-4050 as well as to determine the pharmacokinetic profile of PBI-4050 following multiple oral doses over ten days in patients with stage IIIb or IV stable renal impairment.

The PBI-4050 Phase Ib multi-dose trial was conducted in eight patients with six patients receiving PBI-4050 and two patients receiving matching placebo.

ProMetic chief medical officer Dr John Moran said: "Since fibrosis is the pathological pathway leading to organ failure and death in many diseases of differing aetiologies and affecting various organs, we plan to test the efficacy of this drug in several of fibrosis-related conditions"

Following CTA clearance by Health Canada, patient enrollment in PBI-4050 metabolic syndrome and type 2 diabetes Phase II trial will be initiated in April 2015.

The company has also received orphan drug designation from the US FDA for PBI-4050 to treat Idiopathic Pulmonary Fibrosis (IPF), while a phase II trial in IPF has been cleared by Health Canada and is scheduled to begin in the coming weeks.

Both the 12 week, open-label, single-arm, exploratory Phase II trials are designed to evaluate the safety and tolerability of PBI-4050 in 40 patients suffering from IPF and 12 to 36 patients suffering from the metabolic syndrome and the resulting type 2 diabetes.

After securing confirmation of PBI-4050’s safety profile in both healthy volunteers and patients, the company will expand its clinical programs in both the US and EU in existing indications and in rare disease indications associated with fibrosis.