Promedior Announces Pivotal Path for PRM-151 in Idiopathic Pulmonary Fibrosis Following Positive End-of-Phase 2 Meeting with FDA
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Promedior, Inc., a clinical stage biotechnology company developing novel therapeutics for the treatment of fibrosis, today announced that it has completed an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the study of PRM-151, a novel investigational anti-fibrotic immunomodulator, in patients with Idiopathic Pulmonary Fibrosis (IPF). Pursuant to the FDA meeting, the Company reached an agreement with the Agency on the design of the Phase 3 study for registration. 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, MD, Chief Medical Officer of Promedior. “Importantly, this program offers the opportunity to include both 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. We look forward to initiating the Phase 3 study in 2019, and to the continued exploration of our strategic options for advancing PRM-151 in IPF, while also further advancing our development pipeline in additional serious fibrotic diseases in which it has indicated therapeutic potential.”
“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,” said Ganesh Raghu, M.D., Professor of Medicine and Director of the Center for Interstitial lung diseases, University of Washington, Seattle, WA, USA. “The results of the Phase 2 study demonstrated a significant treatment effect for PRM-151 versus placebo in the change of lung function, measured as FVC and suggest the potential of PRM-151 to stabilize the distance walked over 6 minutes time in patients with IPF over a 28-week period, including those who received combination with standard of care treatment. 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.”