Date: 2014-09-22
Type of information: Presentation of results at a congress
phase: 1b
Announcement: presentation of results at the 18th International Colloquium on Lung and Airway Fibrosis (ICLAF), in Mont Tremblant, Quebec, Canada
Company: Promedior (USA - MA)
Product: PRM-151 (recombinant human pentraxin-2)
Action
mechanism: PRM-151 is a recombinant form of an endogenous human protein, pentraxin-2 (PTX-2), that is specifically active at the site of tissue damage. PRM-151 is an agonist that acts as a monocyte/macrophage differentiation factor to prevent and potentially reverse fibrosis. PRM-151 has shown broad anti-fibrotic activity in multiple preclinical models of fibrotic disease, including pulmonary fibrosis, acute and chronic nephropathy, liver fibrosis, and age-related macular degeneration. PRM-151 has Orphan Designation in the US and EU for treatment of Idiopathic Pulmonary Fibrosis.
Disease: idiopathic pulmonary fibrosis
Therapeutic area: Lung diseases - Respiratory diseases - Rare diseases
Country:
Trial
details: The Phase 1b clinical trial was a randomized, double-blind, placebo-controlled study 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. The 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.
Latest
news: * On September 22, 2014, Promedior, a clinical stage biotechnology company developing novel therapeutics for the treatment of fibrosis, announced that retrospective quantitative imaging data from the Company’s Phase 1b clinical trial of PRM-151, for the treatment of idiopathic pulmonary fibrosis (IPF), was presented in a poster at the 18th International Colloquium on Lung and Airway Fibrosis (ICLAF), which is being held in Mont Tremblant, Quebec, Canada, from September 20-24, 2014. The data show that changes seen with structural and functional imaging of IPF patient’s lungs generally correlate with and appear complementary to pulmonary function tests. Both methods showed correlation with increases in Forced Vital Capacity (FVC) % predicted, normal lung, and lobar volumes in some subjects treated with PRM-151. In all placebo patients, decreases in both FVC % predicted and normal lung were observed, with decreased lobar volumes in some patients. With a novel mechanism of action that is targeted to prevent and reverse fibrosis, PRM-151 has the potential to address the fundamental fibrotic pathology of IPF. Retrospective analyses of High Resolution CTs (HRCT) from the Phase 1b study assessed both volumetric quantification of interstitial lung abnormalities (ILA) and lobar volumes. The data support prospective use of these imaging techniques as biomarker endpoints to provide a more robust signal determination to support rapid development and require fewer patients in future clinical trials of PRM-151 in IPF.
