Prometic Life Sciences declares outcome of FDA meet for PBI-4050

Clinical development Type C meeting with the US Food and Drug Administration (FDA) for its orally active anti-fibrotic lead drug candidate, PBI-4050 was declared by Prometic Life Sciences. The aim of the meeting was to clinch final agreement on the design of the Phase 3 pivotal clinical trial for PBI-4050 in patients with idiopathic pulmonary fibrosis (IPF).

Following the recommendations from FDA, Prometic now will undertake an “all comers study”. The 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. Therefore, 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.”

Dr. Joseph Parker, Senior Director, Prometic Clinical Affairs, who is overseeing the study claimed “We are very pleased by the outcome of the meeting with the FDA. The recommendations provided by the FDA will allow us to conduct a clinical trial that is much more reflective of current treatment of IPF patients.”

Image Source: Prometic Life Sciences