31 January 2018 - - Laval, Canada-based biopharmaceutical company Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) had a successful clinical development Type C meeting with the US Food and Drug Administration for its orally active anti-fibrotic lead drug candidate, PBI-4050, the company said.
The purpose of the meeting was to reach final agreement on the design of the Phase 3 pivotal clinical trial for PBI-4050 in patients with idiopathic pulmonary fibrosis (IPF).
Based on recommendations from the FDA, enrollment criteria will be greatly simplified such that the study will enroll patients with mild-to-moderate IPF, regardless of whether they are on background standard of care with nintedanib (OFEV) or not. Patients taking pirfenidone will be excluded because of a known drug-drug interaction between pirfenidone and PBI-4050.
The study will provide efficacy data on both PBI-4050 as a stand-alone agent, and as an add-on to nintedanib, and will be part of the dataset to support a simple, all-inclusive indication "for the treatment of IPF."
The primary endpoint is the annual rate of decline in forced vital capacity (FVC).
PBI-4050 has excellent safety and efficacy profiles in a large number of animal models of fibrosis affecting different organs, including the lung, liver, heart, kidney, and pancreas. The effects of PBI-4050 demonstrated in animal models have been replicated in Phase 2 studies in IPF, in Type 2 diabetes with metabolic syndrome, and in Alström syndrome.
Prometic develops bioseparations, plasma-derived therapeutics and small-molecule therapeutic products targeting unmet medical needs in the fields of fibrosis, cancer, and autoimmune diseases/inflammation.The company also offers technologies for large-scale purification of biologics, drug development, proteomics, and the elimination of pathogens to a growing base of industry leaders.
Headquartered in Laval,Canada, the company has R and D facilities in the UK, the US, and Canada; manufacturing facilities in the UK; and commercial activities in the US, Canada, Europe, and Asia.