The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has cleared ProMetic Life Sciences' clinical trial application (CTA) for its anti-fibrotic lead drug candidate PBI-4050 in patients with type 2 diabetes and severe multi-organ fibrosis.
The biopharmaceutical firm expects to enroll patients later this year. ProMetic is currently undertaking a phase II clinical trial of PBI-4050 in Canada in patients with metabolic syndrome and related type 2 diabetes.
Safety and tolerability of PBI-4050 has already been evaluated in patients. The Canadian study was also designed to identify early signs of improvement in their metabolic status.
It was also intended to demonstrate that the pharmacological effects observed in preclinical models translate to humans.
ProMetic chief medical officer John Moran said: "PBI-4050 has demonstrated anti-fibrotic activity in multiple organs in several different models as well as a positive effect on insulin resistance and on preservation of insulin production by the pancreas in gold standard preclinical diabetic models.
"The trial in the UK will monitor several biomarkers of diabetes and of fibrosis and will also study the effect and function of the affected organs, including the liver, heart, and pancreas."
The phase II study will initially recruit 20 patients and the first treatment will be for six months with a potential extension.
The study aims to assess the safety and tolerability of PBI-4050, as well as its effects of on key organ function, disease progression and inflammatory/fibrotic markers.