ProMetic Life Sciences Inc. reported that their investigational PBI-4050 drug, the firm’s leading anti-fibrotic candidate to address idiopathic pulmonary fibrosis (IPF), was approved to begin clinical trials following CTA clearance by Health Canada.
IPF is a devastating, chronic and fatal disease that is characterized by a progressive decline in lung function. It is a lung disease that features the replacement of the lungs’ small air sacs with scar tissue, leading to dyspnea. IPF has a very poor prognosis and usually affects people aged between 50 and 70 years old, with men and those with a smoking history being more affected. 130,000 Americans are diagnosed with the disease.
Researchers used a standard animal model that emulated pulmonary fibrosis in humans, demonstrating favorable outcomes for PBI-4050 compared to a recently approved drug as treatment for IPF. PBI-4050 significantly reduced scarring in the lungs when compared to non-treated animals. Scientists also found that PBI-4050 and Pirfenidone combined generated unprecedented reduction of fibrotic markers, which indicates that there is a possibility of stabilization and clinical improvement in lung function.
Dr. John Moran, ProMetic’s Chief Medical Officer, said in a press release: “We are very pleased to be starting this Phase II clinical trial in IPF patients. The prospect of demonstrating that the significant improvements in lung function seen in our preclinical models can actually translate into similar improvements in IPF patients is obviously of great interest to all involved.”
The goals of this upcoming study, a 12-week, single-arm, open-label and exploratory Phase 2 evaluation, include the evaluation of both tolerability and safety of the compound in 40 individuals suffering with IPF and to determine the effects of PBI-4050 on disease progression, pulmonary function and inflammatory/fibrotic markers.
The company recently completed PBI-4050’s Phase I clinical trial in 40 healthy volunteers and was found to be well tolerated, safe and had no serious adverse events. ProMetic has also begun to enroll patients suffering with diabetic kidney disease (DKD) in the multi-dose part of the Phase Ib trial, and results are expected to be reported near the end of the first quarter 2015.