Promedior, Inc., a clinical stage biotechnology company developing novel therapies to treat fibrotic and inflammatory diseases, announced today that it has initiated a Phase 2a clinical study of PRM-151 to evaluate the efficacy, safety, and tolerability of PRM-151 in preventing post-surgical scarring in glaucoma patients following glaucoma filtration surgery. There currently are no approved drugs for preventing post-surgical scarring in glaucoma, and there are no approved anti-fibrotic drug therapies in the U.S. or Europe for any fibrotic disease.
“The initiation of this clinical trial represents important progress for Promedior as we believe that PRM-151 represents a novel and powerful first-in-class agent to prevent and treat fibrotic diseases”
Promedior's lead product, PRM-151, is a recombinant form of a naturally circulating human protein, Pentraxin-2 (PTX-2, also called human SAP), 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 glaucoma, pulmonary fibrosis, and acute and chronic nephropathy. Promedior successfully completed a Phase 1 clinical study of PRM-151 earlier in 2010.
"The initiation of this clinical trial represents important progress for Promedior as we believe that PRM-151 represents a novel and powerful first-in-class agent to prevent and treat fibrotic diseases," said Dominick Colangelo, President and Chief Executive Officer of Promedior. "This study is designed to clearly demonstrate the anti-fibrotic activity of PRM-151 which we believe, based upon a common cellular immune mechanism across tissues and organs, may translate into potential therapeutic utility of PRM-151 in other ophthalmic surgical procedures and chronic eye diseases involving fibrosis, as well as other chronic systemic diseases such as pulmonary fibrosis and kidney fibrosis."
This multicenter, multinational, randomized, double-masked, placebo-controlled Phase 2 study is expected to enroll approximately 130 patients. The primary efficacy endpoints of the study will be improvement and maintenance of intraocular pressure and reduction in post-surgical scarring as assessed by optical coherence tomography (OCT) and a clinical assessment scale. PRM-151 will be administered as a subconjunctival injection at the end of surgery and at additional designated timepoints following 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. Beyond the current Phase 2a glaucoma surgery study, Promedior anticipates initiating a Phase 1b multiple-dose study in patients with idiopathic pulmonary fibrosis (IPF) and a Phase 1b study in a second ophthalmic indication within the next year.