Resolvyx to Initiate Phase 1/2 Clinical Trial with RX-10045 in Patients with Dry Eye
BEDFORD, MA – November 20, 2008 -- Resolvyx Pharmaceuticals, Inc., the leading resolvin therapeutics company, today announced that the thirty day review period by the U.S. Food and Drug Administration (FDA) is now complete for an investigational new drug application (IND), with reference #77,896, supporting the use of RX-10045 for the treatment of ophthalmic diseases. The opening of this IND, submitted in early October, allows Resolvyx to initiate its first clinical trial, which will be a placebo-controlled, Phase 1/2 study of RX-10045 in 200 patients with moderate-severe dry eye. The company will initiate this study before the end of the year.
"We are excited that RX-10045 has reached this important milestone, as the first IND for a resolvin therapeutic and our company’s lead clinical candidate” said Paul Rubin, Chief Executive Officer of Resolvyx. "We are moving aggressively to start this Phase 1/2 trial. RX-10045 has promise as a novel therapeutic approach for the treatment of this extremely prevalent disorder for which there is clearly a need for effective drugs."
RX-10045 is an isopropyl ester pro-drug of the active Resolvin compound, RX-10008. Resolvyx has conducted in vivo preclinical studies that have demonstrated that RX-10008 is effective in preventing the deleterious effects of dry eye as well as restoring healthy cell function. RX-10008 has been shown to be highly effective in preventing clinical 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 has been shown to potently block several key pro-inflammatory mediators in dry eye and to accelerate 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.
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 http://www.resolvyx.com.