Clinical Trials

PROMOTE

PROMOTE is inspired by PRM-151’s potential ability to PROMOTE:
  • Prevention of new fibrosis
  • Reduction of established fibrosis
  • Improved organ function
Promedior is currently conducting two Phase 2 clinical trials to demonstrate the ability of its product candidate, PRM-151, to address the unmet needs of patients in Myelofibrosis (MF) and Idiopathic Pulmonary Fibrosis (IPF). PRM-151 is formulated for intravenous injection.

Myelofibrosis (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.

Idiopathic Pulmonary Fibrosis (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.

 
Contact Information
Email: promote@promedior.com
Telephone: 781-538-4305