Participation in Clinical Trials is voluntary and participants must meet eligibility criteria.
PRM-151 is a recombinant form of Pentraxin-2, an endogenous human protein that actively works at the site of tissue damage, as a monocyte/macrophage differentiation factor and as an agonist with the potential to both prevent and reverse fibrosis. Pre-clinical and clinical data exist to support the investigation of PRM-151 in the treatment of fibrotic diseases. PRM-151 is administered intravenously.
PRM-151 in MF
The Phase 2 Clinical Trial to evaluate PRM-151 in MF is a multi-center, randomized, double-blind, two stage, adaptive design study to determine efficacy and safety of PRM-151 in patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), or Post-Essential Thrombocythemia MF (post-ET MF). Patients will be randomized to one of three doses: 0.3 mg/kg, 3.0 mg/kg or 10 mg/kg of PRM-151. The primary objective is to determine the effect size of three different doses of PRM-151 on reduction in bone marrow fibrosis by ≥1 grade in intermediate-1, intermediate—2, and high risk patients with PMF, post PV-MF, or post ET-MF who are anemic or thrombocytopenic and who are ineligible for, intolerant of, or have had an inadequate response to ruxolitinib.
Clinical Research Sites for MF Study
PRM-151 in IPF
The Phase 2 Clinical Trial to evaluate PRM-151 in IPF is a randomized, double-blind, placebo-controlled, pilot study designed to determine efficacy and safety of PRM-151 in patients with Idiopathic Pulmonary Fibrosis (IPF). Patients meeting the eligibility criteria for the study will be randomized to PRM-151 10 mg/kg every 4 weeks or placebo. Efficacy will be evaluated through pulmonary function tests (PFTs), high-resolution CT (HRCT), 6-minute walk test (6MWT), and Patient Reported Outcomes (PROs). The primary objective is to determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling patients on a stable dose of pirfenidone or nintedanib and patients not on other treatment for IPF.
Clinical Research Sites for IPF Study
Participation in Clinical Trials
Clinical Trials are used to evaluate whether a drug is effective and safe for people to use. Clinical Trials are conducted by qualified doctors and done in accordance with ICH (International Conference of Harmonization) guidelines for Good Clinical Practice (GCP). This is an international ethical and scientific quality standard for the conduct of trials. Clinical trials must be approved by an IRB (Independent Review Board) and regulatory guidelines set by the country that the study is being conducted in are followed.