The US Food and Drug Administration has granted Fast Track designation to PBI-4050, ProMetic Life Sciences’ potential treatment for idiopathic pulmonary fibrosis (IPF).
Regulators recently approved ProMetic’s Investigational New Drug application for PBI-4050 and the company’s design for pivotal Phase 2/3 clinical trials of the therapy. A pivotal trial is one that can provide the FDA with the evidence it needs to approve a drug.
PBI-4050 is designed to regulate lung inflammation and tissue scarring. It reduces levels of cytokines, or chemical signals that promote scarring. It also inhibits two other processes involved in scarring, or fibrosis: fibrocyte differentiation and microfibroblast activation. Fibrocytes differentiate — or evolve into — fibrosis-promoting cells known as fibroblasts. Microfibroblast activation gets the fibrosis process started.