Promedior is advancing its product candidates through clinical studies to demonstrate its ability to address the unmet needs of patients in a number of serious fibrotic diseases. The company is currently focused on rare fibrotic diseases, such as idiopathic pulmonary fibrosis (IPF) and myelofibrosis, and we are also interested in retinal fibrovascular diseases such as age-related macular degeneration (AMD).
PRM-151: Lead Product Candidate
Promedior's lead product, PRM-151, is a recombinant form of human pentraxin-2 protein (rhPTX-2) formulated for intravenous injection. Promedior is initially focusing the clinical development of PRM-151 on rare systemic fibrotic diseases, such as Idiopathic Pulmonary Fibrosis (IPF) and myelofibrosis. Highlights of PRM-151's clinical development include:
- A Phase 1a clinical study in healthy subjects and IPF patients demonstrated that PRM-151 was safe and well-tolerated
- A Phase 1b randomized, double-blind, placebo-controlled, multiple ascending dose study in IPF patients demonstrated that PRM-151 was generally safe and well‐tolerated and resulted in a mean improvement in Forced Vital Capacity (FVC) at 8 weeks after dosing for only two weeks, whereas patients receiving placebo had a decline in FVC. These data were presented at the American Thoracic Society Annual Meeting on May 22, 2013.
- A Phase 2 clinical trial to evaluate PRM-151 in patients with myelofibrosis is ongoing. This trial is a multi-center, two-stage, adaptive design study to determine the efficacy and safety of PRM-151 as a single agent or added to a stable dose of ruxolitinib in patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), or Post-Essential Thrombocythemia MF (post-ET MF). Data were presented at the 2014 American Society of Clinical Oncology (ASCO) and the 2014 European Hematology Association meetings in June. Positive preliminary data demonstrated biologic activity with improvements across clinically relevant measures, including bone marrow fibrosis, hemoglobin, platelets, spleen volume, and symptoms. Clinical data showed improvements in four independent treatment groups of myelofibrosis patients who received PRM-151 weekly or monthly, either as a single agent or in patients with no further improvements on a stable dose of ruxolitinib1. Importantly, PRM-151 demonstrated safety and tolerability both alone and in combination with ruxolitinib, with no evidence of the myelosuppression commonly observed with other treatments. This recent data in myelofibrosis demonstrates the potential of Promedior’s immuno-oncology approach in fibrotic cancers.
PRM-151 has demonstrated efficacy in multiple preclinical models of fibrotic disease, including the reduction of established pulmonary fibrosis.
Further details related to PRM-151's therapeutic programs in IPF and myelofibrosis can be found here
PRM-167: Lead Ocular Product Candidate
Promedior is also interested in developing PRM-167, a variant of rhPTX-2 developed specifically for intravitreal delivery in retinal fibrovascular diseases such as Age-Related Macular Degeneration (AMD) and Diabetic Retinopathy (DR).
Promedior has demonstrated robust efficacy of intravitreally-delivered Pentraxin-2 in preclinical models of AMD and macular edema, including models encompassing choroidal neovascularization, retinal neovascularization, and proliferative vitreoretinopathy (PVR, retinal detachment). In these models, Pentraxin-2 promoted the healing processes, resulting in reduced neovascularization, vascular leakage and fibrosis.
Further details related to plans for PRM-167's therapeutic programs in retinal fibrovascular diseases can be found here
Promedior is developing a proprietary formulation of Pentraxin-2 therapeutics for self-administered inhaled local delivery in lung diseases such as idiopathic pulmonary fibrosis (IPF), chronic obstructive pulmonary disease (COPD) and asthma. Promedior has demonstrated strong preclinical efficacy of Pentraxin-2 in bleomycin-induced lung fibrosis and fungal-induced asthma models following inhaled delivery. In these models, Pentraxin-2 was seen to promote resolution pathways, while inhibiting cellular processes that drive harmful fibrosis and inflammation.