Promedior, Inc., a leader in the development of novel therapeutics for the treatment of fibrotic diseases and tissue remodeling, announced today that the European Commission has granted Orphan Medicinal Product Designation to its lead drug candidate PRM-151 for use in the prevention of scarring post glaucoma filtration surgery. Glaucoma filtration surgery generally is used to treat patients with advanced glaucoma that are at high risk for visual loss. Scarring post glaucoma surgery is a serious complication that causes poor surgical outcomes and may lead to progressive loss of vision for these high risk patients.
PRM-151(rhSAP) is a recombinant form of human Serum Amyloid P, a highly conserved natural human serum protein that mediates its anti-fibrotic activity by targeting the specific cell populations that orchestrate fibrosis and tissue remodeling, namely monocytes and macrophages. PRM-151 has demonstrated an outstanding safety profile and robust preclinical efficacy by reducing fibrosis in multiple tissues, organs, and disease models. Promedior initiated a Phase 1 clinical trial of PRM-151 in July 2009 to evaluate the safety, tolerability, pharmacokinetics and exploratory pharmacodynamics of ascending single intravenous doses of PRM-151.
The EMEA’s orphan medicinal products program is designed to promote the development of products for the diagnosis, prevention or treatment of rare, life-threatening or chronically debilitating conditions. Orphan medicinal product designation provides several incentives to sponsors, including 10 years of marketing exclusivity, protocol assistance and scientific advice during product development, and fee reductions or exemptions for regulatory activities including scientific advice, applications for marketing authorization, inspections, and renewals.
"The orphan medicinal product designation for PRM-151 reflects the therapeutic potential of PRM-151 to prevent scarring post glaucoma filtration surgery and the lack of approved alternative therapies for this serious surgical complication," said Dominick Colangelo, Chief Executive Officer of Promedior. "This designation provides Promedior significant development and commercial advantages as we continue the development of this first-in-class therapy for the treatment of diseases involving scarring and fibrosis in the eye and other organ systems."