Market Overview

ProMetic's PBI-4050 Granted Orphan Drug Designation by EC for Treatment of Idiopathic Pulmonary Fibrosis

Share:

ProMetic Life Sciences Inc. (OTC: PFSCF) announced today that an orphan drug designation status has been granted for its lead drug candidate, PBI-4050, for the treatment of idiopathic pulmonary fibrosis ("IPF"), by the European Commission. ProMetic is currently investigating the safety, tolerability and effects of PBI-4050 on pulmonary function, disease…ProMetic Life Sciences Inc. (OTC: PFSCF announced today that an orphan drug designation status has been granted for its lead drug candidate, PBI-4050, for the treatment of idiopathic pulmonary fibrosis ("IPF"), by the European Commission. ProMetic is currently investigating the safety, tolerability and effects of PBI-4050 on pulmonary function, disease progression and inflammatory/fibrotic biomarkers in a Canadian open-label Phase II study in 40 patients suffering from IPF. ProMetic also expects to file an IND with the FDA during the first quarter of 2016 for a multi-center, double-blind, placebo-controlled pivotal study with IPF patients currently on pirfenidone or nintedanib randomized to receive either PBI-4050 or a placebo. Commenting on the European orphan drug designation grant, Mr. Pierre Laurin, ProMetic's President and Chief Executive Officer, said: "This is the second orphan drug designation secured by ProMetic regarding PBI-4050 for the treatment of IPF following the similar grant by the US FDA in February 2015. This grant confirms that there is still an urgent need in Europe for a safe and effective treatment of this devastating disease" . In gold standard animal models proven to emulate pulmonary fibrosis in humans,

See full press release

Posted-In: News Press Releases

 

Related Articles (PFSCF)

View Comments and Join the Discussion!