ProMetic Life Sciences, Inc., a biopharmaceutical corporation active in the development of novel therapeutic products targeting unmet medical needs in several fields, including fibrosis, is pleased to announce it recently concluded a successful Pre-Investigational New Drug (Pre-IND) meeting with the U.S. Food and Drug Administration (FDA) regarding its investigational anti-fibrotic product candidate, PBI-4050 for idiopathic pulmonary fibrosis (IPF).
The ProMetic-FDA meeting centered on clinical development strategies for PBI-4050 in IPF patients, specifically a pivotal study design that can integrate the latest guidelines in IPF care and management. Today, the only two medications approved for IPF have only been able to demonstrate the ability to slow disease progression, not cure it. ProMetic hopes PBI-4050 becomes a significant contribution to the IPF treatment market, whether as mono- or adjunct therapy. Previously completed preclinical studies showed the drug’s synergistic effects when given with pirfenidone (Esbriet), an FDA-approved prescription medicine for the treatment of IPF.
“The outcome of this meeting is that ProMetic will proceed with a placebo-controlled pivotal study in the USA in order to evaluate the combination of PBI-4050 with nintedanib or pirfenidone”, commented Dr. John Moran, ProMetic’s Chief Medical Officer in a press release. “This is an important milestone as it allows us to move forward with this multi-center study sooner than anticipated, and with a clear regulatory path”.
The upcoming study for PBI-4050 in patients with IPF will be a multi-center pivotal study, with a double-blind, placebo-controlled design. Participants under either pirfenidone or nintedanib therapy will be randomized to receive either PBI-4050 or a placebo. The drug’s benefit will be measured through the patients’ resulting difference in forced vital capacity (FVC). While the company’s scientists have yet to completely finalize the study’s design, ProMetic is confident it can file an IND for PBI-4050 within the first quarter of 2016.
“To date, PBI-4050 has presented a remarkable safety and tolerability profile throughout our phase I trials and ongoing phase II clinical trial,” said Mr. Pierre Laurin, CEO of ProMetic. “The objective of this pivotal trial is to demonstrate that PBI-4050 can safely provide significant additional clinical benefits to IPF patients and we appreciate the input of the FDA regarding the design of the trial.”