Promedior, Inc., a clinical stage biotechnology company developing novel biologic therapeutics for the treatment of fibrosis, announced today that it has initiated a Phase 2 clinical trial to evaluate PRM-151, its lead product candidate, in patients with myelofibrosis. Promedior is advancing PRM-151, a recombinant form of an endogenous human protein that offers the potential to prevent and potentially reverse fibrosis. The Phase 2 clinical study of PRM-151 in patients with myelofibrosis, which is expected to complete in 2014, expands Promedior's clinical focus beyond IPF to myelofibrosis, another serious, life-limiting orphan disease with significant unmet medical need.
"Advancing the clinical development of PRM-151, our lead product candidate, into clinical studies in myelofibrosis patients is a significant milestone for Promedior," said Elizabeth G. Trehu, MD, FACP, Promedior's Chief Medical Officer. "We are optimistic that data from this study, combined with the encouraging data in IPF, will demonstrate that PRM-151's novel mechanism of action is applicable to a wide range of fibrotic diseases."
Promedior's clinical development program in myelofibrosis with PRM-151 builds upon a randomized, placebo-controlled clinical study in patients with IPF, in which PRM-151 was generally safe and well‐tolerated and resulted in a mean improvement in Forced Vital Capacity (FVC) at 8 weeks after dosing for only two weeks, whereas patients receiving placebo had a decline in FVC. In addition, PRM-151 has demonstrated broad anti-fibrotic activity in multiple industry standard preclinical models of fibrotic disease, including pulmonary fibrosis, acute and chronic nephropathy, liver fibrosis, and age-related macular degeneration.
"Despite the success of JAK inhibitors, there is still a critical need for new therapeutic approaches for patients with myelofibrosis. With its unique mechanism of action that offers the potential to prevent and reverse fibrosis, Promedior's PRM-151 has the potential to become a first-in-class disease-modifying treatment for this debilitating disease," said Srdan Verstovsek, MD, PhD, Professor and Section Chief for Myeloproliferative Neoplasms, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, and principal investigator for the study.
This clinical trial is a multi-center, two stage, adaptive design Phase 2 study to determine the efficacy and safety of PRM-151 as a single agent or added to a stable dose of ruxolitinib in patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), or Post-Essential Thrombocythemia MF (post-ET MF). The primary endpoint is response rate according to the International Working Group- Myeloproliferative Neoplasms Research and Treatment criteria, a comprehensive assessment tool designed by an international group of experts to objectively measure the effectiveness of treatments for MF¹. Approximately 24 patients are expected to enroll in the first stage of the study, with up to 80 additional patients in the second stage. For additional details about this clinical trial, please visit www.clinicaltrials.gov.