First post-surgical scarring therapeutic for glaucoma patients moves to Phase II study

September 15, 2010

A Phase 2a clinical study has been initiated for Promedior's anti-fibrotic therapeutic, PRM-151, to evaluate its efficacy, safety and tolerability.

A Phase 2a clinical study has been initiated for Promedior’s anti-fibrotic therapeutic, PRM-151, to evaluate its efficacy, safety and tolerability. This drug is aimed at the prevention of post-surgical scarring in glaucoma patients. Currently, there are no approved drugs for this purpose or approved anti-fibrotic drug therapies in Europe or the US for any fibrotic disease.

PRM-151 is a recombinant form of a naturally circulating human protein, Pentraxin-2. This protein controls a basic process of the immune system and activates the body's natural ability to resolve tissue damage in disease processes that cause fibrosis and inflammation. A successful Phase 1 clinical study was completed at the beginning of 2010 and the drug has shown anti-fibrotic and anti-inflammatory activity in preclinical models.

Commenting on the initiation of Phase 2a clinical study Dominick Colangelo, president and CEO of Promedior, stated, “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…”

It is expected that 130 patients will be enrolled in the study who will receive the drug as a subconjunctival injection at the end of surgery and at additional designated times post-op. The primary efficacy endpoints will be improvement and maintenance of intraocular pressure and reduction in post-surgical scarring, which will be assessed by optical coherence tomography (OCT) and a clinical assessment scale.

This drug was granted Orphan Medicinal Product Designation by the European Commission in September 2009 for use in the prevention of scarring post glaucoma filtration surgery.