Promedior, Inc. unveiled data from a clinical study of PRM-151 in an oral presentation at the 2013 American Thoracic Society (ATS) International Conference in Philadelphia. The clinical data from a randomized, double-blind, placebo controlled Phase 1b multiple ascending dose study showed that PRM-151 was generally safe and well tolerated in patients with idiopathic pulmonary fibrosis (IPF). In addition, the study showed encouraging results in exploratory efficacy endpoints.
"We are excited to present data from this clinical study, which underscore the safety and potential of PRM-151 as a novel therapeutic to treat IPF, a serious and life threatening orphan fibrotic disease,” said Beth Trehu, MD, FACP, Chief Medical Officer. "The safety profile and intriguing efficacy signals seen in this Phase 1b multiple dose trial of PRM-151 in patients with IPF support advancement of this clinical program to Phase 2. We are also initiating clinical development of PRM-151 in myelofibrosis, another serious and life threatening orphan fibrotic disease.”
The oral presentation at ATS 2013 showed data from a randomized, double blind, placebo controlled study that was performed in 21 patients with IPF. In the study, PRM-151 doses of 1, 5 and 10 mg/kg or placebo were administered intravenously on days 1, 3, 5, 8 and 15. Patients were followed for 57 days after receiving their first dose. This Phase 1b clinical study’s primary endpoint was safety and tolerability, and PRM-151 was shown to be generally safe and well tolerated across all study participants, with no serious adverse events. Additionally, the clinical study measured exploratory clinical endpoints, including Forced Vital Capacity (FVC), Diffusion Capacity of the Lung for Carbon Monoxide (DLCO), six minute walk test, quality of life, and several biomarkers of fibrosis.