Resolvyx Announces Initiation Of Phase I/II Clinical Trial Of Novel Resolvin Therapeutic RX-10045 In Patients With Dry Eye

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials
Article Date: 01 Jan 2009 - 4:00 PST

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Resolvyx Pharmaceuticals, Inc., the leading resolvin therapeutics company, today announced that it has initiated the first human clinical trial evaluating a resolvin therapeutic, RX-10045, in a Phase I/II clinical trial in patients with moderate-severe dry eye syndrome. RX-10045 is a synthetic analog of RvE1, a naturally occurring resolvin with potent anti-inflammatory and cell-sparing activities in laboratory testing. "This is an important milestone for Resolvyx, as initiation of this trial offers the first opportunity to demonstrate the clinical importance of resolvins as a new class of therapeutics," said Paul Rubin, M.D., Chief Executive Officer of Resolvyx. "We are delighted to have successfully initiated this study, and anticipate receiving data in the first half of 2009."

The randomized, multi-center, placebo-controlled, dose-ranging study is designed to evaluate the safety, tolerability and efficacy of RX-10045 in improving the signs and symptoms of dry eye. Approximately 200 patients will be enrolled in the trial which will evaluate the effects of RX-10045 on multiple endpoints recognized by the U.S. Food and Drug Administration (FDA): objective measures of corneal and conjunctival staining, tear film break-up time, as well as subjective measures of discomfort.

"Based on its unique mechanism of action and compelling preclinical data, we are hopeful that RX-10045 will offer a novel therapeutic approach for the treatment dry eye, a widespread eye disease for which there is a significant lack of effective therapies," said, Per Gjorstrup, M.D., Ph.D., Chief Medical Officer of Resolvyx.

About RX-10045

RX-10045 is Resolvyx's lead resolvin therapeutic and is an isopropyl ester pro-drug of the active resolvin compound, RX-10008. Resolvyx has conducted laboratory studies demonstrating that RX-10008 is effective in preventing the deleterious effects of dry eye, as well as restoring healthy cell function. In the same studies, RX-10008 is highly effective in preventing signs of dry eye, including decreasing corneal inflammation, reducing corneal epithelial damage, and preventing loss of goblet cells (the cells responsible for maintaining tear film integrity). In addition, RX-10008 potently blocks several key pro-inflammatory mediators in dry eye and to accelerates corneal tissue repair with an effect level comparable to that seen with epidermal growth factor (EGF), the most potent previously-known mediator of corneal tissue repair.

About Dry Eye Syndrome

Dry eye syndrome is one of the most common problems treated by eye physicians; an estimated 25-30 million Americans suffer from dry eye and the worldwide prevalence closely parallels that of the United States. Dry eye is a chronic multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. Dry eye can make it more difficult to perform some visual activities for an extended period of time, and it can decrease tolerance for dry environments.

About Resolvins

Resolvins are a recently discovered family of naturally-occurring, small molecule lipid mediators that can be targeted to treat a wide range of diseases. In particular, resolvins act to protect healthy tissue during an immuno-inflammatory response to infection, injury or other environmental challenge, and then act to resolve inflammation and promote healing after the insult has passed. Resolvins are shown to be highly potent and efficacious in pre-clinical models of asthma, atherosclerosis, rheumatoid arthritis, inflammatory bowel disease, dry eye and retinal disease, among others.

Resolvins are potential drug candidates to treat a broad range of acute and chronic diseases caused by a failure to resolve the inflammatory response and restore immune homeostasis. Such diseases include auto-immune diseases (like Crohn's disease, psoriasis and rheumatoid arthritis), allergic diseases (like asthma) and chronic inflammatory diseases (like atherosclerosis, degenerative retinal diseases, chronic dry eye and Alzheimer's disease). Resolvins offer an entirely novel biological approach to treating significant inflammatory diseases, with a decreased potential for immuno-suppression.

About Resolvyx Pharmaceuticals

Resolvyx Pharmaceuticals is a privately-held biopharmaceutical company dedicated to the discovery, development and commercialization of resolvins, a novel class of therapies to treat inflammatory diseases and their complications. Resolvyx's drug R&D programs are focused on characterizing and developing resolvin-based compounds. With its experienced management team, world-class scientists and leading investors, Resolvyx is well-positioned to capitalize on its extensive portfolio of more than 55 patents and applications.

The company's headquarters are in Bedford, Massachusetts. For additional information, please visit www.resolvyx.com