ProMetic Life Sciences Inc. (www.prometic.com) has reported that its orally active lead drug candidate, PBI-4050, has been approved to commence a clinical trial in patients suffering from metabolic syndrome and resulting type 2 diabetes, following the CTA clearance by Health Canada. Metabolic syndrome is a major risk factor for cardiovascular disease and for type 2 diabetes, and consists of the constellation of central (truncal) obesity, high blood triglycerides, low HDL (good) cholesterol, elevated blood pressure, and elevated blood glucose.
“One of the key objectives of this trial is to see whether the significant improvements observed in diabetic animals when treated with PBI-4050 can be translated to humans,” stated Mr Pierre Laurin, President and Chief Executive Officer of ProMetic. “Our scientists and Dr Raymond Harris’ team at Vanderbilt University have clearly demonstrated that PBI-4050 has a direct effect on the pancreas itself, and by reducing inflammation and macrophage infiltration, preserves insulin production in the islets. This trial will therefore monitor several biomarkers of diabetes and of inflammation in patients, which should enable us to quickly evaluate the ability of PBI-4050 to reproduce the same benefits in humans,” added Mr Laurin.
“This is a straightforward open label design where each patient’s progress will be measured against their own respective baseline,” said Dr John Moran, ProMetic’s Chief Medical Officer. “For instance, PBI-4050’s positive effect on insulin resistance and on preservation of insulin production by the pancreas in the preclinical models is observed within a few weeks. Our hope here, in addition to demonstrating PBI-4050’s safety and tolerability in these patients, is that we can also observe similar early signs of improvement in their metabolic status. The initial phase of this clinical programme calls for the enrolment of a minimum of 12 patients and maximum of 36 patients,” added Dr Moran.
ProMetic has successfully completed its PBI-4050 Phase I clinical trial in 40 healthy volunteers, in which it was found to be safe and well tolerated, with no serious adverse events. The Corporation has also started enrolling patients with diabetic kidney disease (DKD) in the multi-dose part of the Phase Ib trial and is expected to report results thereon by the end of the first quarter of 2015.