Thursday, November 20, 2008

Resolvyx moves dry eye drug from IND status to trials

By Mass High Tech Staff

A local biotech company focused on creating anti-inflammatory drugs has been given the official green light to proceed with clinical trials for its ophthalmic disease therapy.

Bedford-based startup Resolvyx Pharmaceuticals Inc. announced Thursday that the U.S. Food and Drug Administration (FDA) had completed its 30-day investigational new drug (IND) review for its RX-10045 treatment for eye disorders. This clears the company to proceed with trials.

Resolvyx’s specialty, resolvins, are naturally occurring small molecules whose task is to defend healthy tissue whenever the body’s immune system responds to infections or injuries, and then resolve inflammation and promote healing after the insult has passed. The resolvin molecules have the potential to treat asthma, atherosclerosis, rheumatoid arthritis and other inflammatory ailments.

Following the FDA’s completed review, Resolvyx plans to begin its Phase 1/2 RX-10045 study by year’s end. The placebo-controlled trial will involve treating 200 patients with moderate- to severe-dry eye. A common affliction, Resolvyx claimed that dry eye syndrome affects 25 million to 30 million Americans. Its symptoms include discomfort, visual disturbance and tear film instability, and the syndrome is accompanied by inflammation of the ocular surface.

This initial dry eye trial will focus on delivering the therapy via an eyedropper, said James Nichols, executive vice president of corporate development at Resolvyx. A second clinical program will begin sometime in the first half of next year using an orally administered Resolvyx drug that will target other inflammatory diseases, such as asthma.

Also on Thursday, Resolvyx announced that the National Neurovision Research Institute (NNRI) would collaborate with it to assess the capabilities of resolvins to cure eye disease. Under the terms of the agreement, the NNRI will fund tests to evaluate Resolvyx’s drugs to treat genetic retinal degenerative diseases and dry, age-related macular degeneration (AMD).

Founded in 2005, Resolvyx’s current technology portfolio includes over 55 patents and applications. In April, it raised $22 million in Series B venture capital financing.