Promedior initiates Phase 1b clinical study of PRM-151 in patients with IPF

Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, announced today that it has initiated a Phase 1b clinical study of PRM-151 to explore the safety, tolerability, pharmacokinetics, and phamacodynamics of PRM-151 in the treatment of patients with idiopathic pulmonary fibrosis (IPF). The study will be conducted at sites in the United States and Europe. There currently are no approved anti-fibrotic drug therapies in the United States or Europe for any fibrotic disease, including IPF.

“We are excited to advance PRM-151 into this clinical study in patients with IPF, as we believe that PRM-151 represents a novel and powerful first-in-class agent to prevent and treat a wide variety of serious fibrotic diseases, including IPF”

Promedior's lead product, PRM-151, is a recombinant form of a naturally circulating human protein, Pentraxin-2 (PTX-2), that regulates a fundamental mechanism of the innate immune system and activates the body's natural ability to resolve tissue damage in disease processes that cause fibrosis and inflammation. PRM-151 has shown broad anti-fibrotic and anti-inflammatory activity in multiple preclinical models of fibrotic disease and inflammation, including pulmonary fibrosis, kidney fibrosis, and glaucoma. Promedior successfully completed a Phase 1a clinical study of PRM-151 in healthy volunteers and pulmonary fibrosis patients in 2010.

"We are excited to advance PRM-151 into this clinical study in patients with IPF, as we believe that PRM-151 represents a novel and powerful first-in-class agent to prevent and treat a wide variety of serious fibrotic diseases, including IPF," said Dominick Colangelo, President and Chief Executive Officer of Promedior. "This is the third clinical trial for our anti-fibrotic platform, and builds upon our recently completed Phase 1a study in which we observed positive effects of PRM-151 on IPF patient biomarkers associated with disease pathology and progression. Looking forward, we are making rapid progress in the clinic in multiple disease indications, and we expect to initiate a third clinical program of PRM-151 in an additional ophthalmology indication in 2011."

The multicenter, multinational, randomized, double-blind, placebo controlled, ascending multiple-dose Phase 1b study will primarily assess the safety, tolerability, pharmacokinetics and pharmacodynamics of PRM-151 administered intravenously to patients with IPF. Pharmacodynamic indications of PRM-151's potential therapeutic efficacy will be explored throughout the study by assessment of specific plasma protein biomarkers and whole blood fibrocyte content, which have been associated with IPF pathology and disease progression. Pulmonary function data and six-minute walk distance will also be collected.

PRM-151 currently is being tested in a Phase 2a clinical study to evaluate the efficacy, safety, and tolerability of PRM-151 in preventing post-surgical scarring in glaucoma patients following glaucoma filtration surgery. PRM-151 was granted Orphan Medicinal Product Designation by the European Commission in September 2009 for use in the prevention of scarring post glaucoma filtration surgery.