Date: 2015-09-08
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Promedior (USA - MA)
Product: PRM-151 (recombinant human pentraxin-2)
Action
mechanism: protein. 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 (IPF)
Therapeutic area: Lung diseases - Respiratory diseases - Rare diseases
Country: Belgium, Czech Republic, Germany, Hungary, The Netherlands, Poland, Spain,UK, USA
Trial
details: The Phase 2 trial is a multi-center, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of PRM-151 as compared to placebo in patients with IPF. The study will include patients currently receiving pirfenidone or nintedanib and patients on no other treatment for IPF. IPF patients included in the study will be randomized 2:1 to PRM-151 at a dose of 10 mg/kg every 4 weeks or placebo. Efficacy will be evaluated through pulmonary function tests (PFTs) including FVC, quantitative imaging analysis of HRCT, six minute walk test (6MWT), and patient reported outcomes (PROs). The study’s primary objective will be to determine the effect of PRM-151 relative to placebo in change from baseline in lung function (as measured by mean FVC% predicted). Safety will be evaluated by adverse events, physical exam, clinical labs and IPF related mortality. Patients in the study will receive PRM-151 or placebo for a minimum of 24 weeks, and all patients will be offered the opportunity to receive PRM-151 after 24 weeks in an open label extension study.
Latest
news: * On September 8, 2015, Promedior announced the initiation of a Phase 2 trial of PRM-151, a novel investigational anti-fibrotic immunomodulator, in patients with Idiopathic Pulmonary Fibrosis (IPF). This randomized, double-blind, placebo-controlled Phase 2 study is designed to determine the efficacy and safety of PRM-151 in approximately 117 patients with IPF. Promedior is initiating this Phase 2 study of PRM-151 in patients with IPF based on data from both the Company’s Phase 1b study of PRM-151 in patients with IPF and a Phase 2 study in patients with myelofibrosis. PRM-151 targets the underlying fibrotic pathology of IPF. A randomized, double-blind, placebo controlled Phase 1b multiple ascending dose study of PRM-151 in patients with IPF assessed changes in Forced Vital Capacity (FVC), and changes in interstitial lung disease features were explored retrospectively by quantitative imaging analysis of high resolution CT (HRCT). Data from the company’s Phase 1b study in patients with IPF have been presented at an oral session at the 2013 Annual Meeting of the American Thoracic Society (ATS) and at the 18th International Colloquium on Lung and Airway Fibrosis (ICLAF). This Phase 2 study of PRM-151 in patients with IPF is planned at centers in the US, UK, Netherlands, Belgium, Spain, Germany, the Czech Republic, Hungary, and Poland.
