ProMetic Life Sciences has just announced that it will begin research on the application of their lead pipeline product for pulmonary fibrosis, PBI-4050, in idiopathic pulmonary fibrosis (IPF), an unusual type of PF that leads to spontaneous lung scarring and is estimated to affect over 130,000 Americans. Every year, 48,000 people are diagnosed with IPF, while 40,000 die from it.
ProMetic’s new focus on IPF comes after a panel of internationally-acclaimed experts gave a positive review of the company’s gathered preclinical data on PBI-4050’s extensive anti-fibrotic properties. The company’s President and CEO, Pierre Laurin, said the product’s preclinical data has consistently exhibited great potential and progress in the pathology and response in biomarkers of this fatal disease. The panel of experts found the Phase I safety data impressive and recommended further investigation on the efficacy of PBI-4050 as a treatment for IPF.
The company’s Chief Medical Officer, Dr. John Moran, said PBI-4050’s preclinical data shows great potential in reducing primary inflammatory and fibrotic indicators, and may prove effective enough to treat a form of pulmonary fibrosis that to this day, has no known cause and cure.
The company revealed its plans to initiate its IPF clinical program in the 4th quarter of 2014 in Canada, before eventually expanding to the United Kingdom and the United States. To help hasten the product’s approval, ProMetic will also apply for an IPF Orphan Drug Designation (ODD) from the US Food and Drug Administration.
One recent preclinical study involved animal models with induced pulmonary fibrosis. Subjects that were given PBI-4050 exhibited significantly less lung fibrosis compared to those receiving Pirfenidone, and a placebo. When PBI-4050 and Pirfenidone were combined, the subjects showed a groundbreaking amount of reduction in fibrotic markers, which suggest great efficacy in upcoming clinical research. Additionally, the drug has been tested to be safe and well-tolerated in a Phase I clinical study that involved 40 healthy participants. Researchers did not observe any serious adverse effects from receiving PB-4050.
In related PF news, Esbriet (pirfenidone) recently received its FDA-approval as a treatment for idiopathic pulmonary fibrosis. The drug’s original goal date was set at November 23, 2014, but because the FDA had granted it a Fast Track status and designated it as an orphan product, it is now closer to improving IPF patients’ lives nationwide.