Maker of fibrosis therapeutics, Promedior, said has agreed with the U.S. Food and Drug Administration (FDA) for registration, on the design of the study of PRM-151, a novel investigational anti-fibrotic immunomodulator, in patients with Idiopathic Pulmonary Fibrosis (IPF).
Promedior said Friday in a press release that the pivotal trial will look at the primary endpoint of forced vital capacity (FVC) and the key secondary endpoint of six-minute walk distance (6MWD) on top of standard of care.
“Our interactions with the FDA have been collaborative and constructive, and their guidance clearly positions PRM-151 as a Phase 3-ready candidate,” said Dr. Renu Gupta, Chief Medical Officer of Promedior.
He said that this program can include FVC and 6MWD as labeled claims which, if supported by the Phase 3 study outcome, would provide both meaningful benefit to patients and important differentiation in the market.
The company said it plans to kick off the Phase 3 study in 2019, and it looks to further explore its strategic options for advancing PRM-151 in IPF, while also further advancing its development pipeline in additional serious fibrotic diseases in which it has indicated therapeutic potential.
Ganesh Raghu, Professor of Medicine and Director of the Center for Interstitial lung diseases, University of Washington in Seattle remarked that the need to abort the disease progression is not met with currently available treatments and the vast majority of patients regrettably do not survive beyond 3-5 years after the diagnosis of IPF is ascertained. He said that PRM-151 versus placebo showed meaningful effect in the Phase 2 study, in the change of lung function. “We look forward to confirming the results of the Phase 2 study of PRM-151 in a larger Phase 3 study and to fully elucidating its disease-modifying potential,” said Raghu.
Promedior said it plans approach the European Medicines Agency in early 2019, expecting to begin the Phase 3 clinical program to support FDA registration in 2019. In parallel, it is seeking a way to advance PRM-151 in other respiratory, oncology, hepatology, and nephrology indications.