Press Releases
Resolvyx Presents Data Demonstrating Potential for Resolvin Therapeutics to Treat Corneal and Retinal Eye Diseases at ARVO 2010 Meeting
Topical Administration Controls Inflammation and Angiogenesis in Model of Herpetic Keratitis
BEDFORD, MA and FORT LAUDERDALE, FL — May 6, 2010 -- Resolvyx Pharmaceuticals, Inc., the leading resolvin therapeutics company, today announced the presentation of data on its novel resolvins for the treatment of both ocular surface diseases and retinal diseases at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in Fort Lauderdale, Florida, being held May 2-6, 2010.
Resolvyx and its collaborators presented new data on one of the company’s lead products, RX-10001, the endogenous resolvin E1 (RvE1), in a corneal model of herpes simplex virus infection. Herpes simplex virus infection is the most common cause of corneal blindness. Administered topically twice a day as a prodrug during infection, RX-10001 was shown to significantly reduce keratitis and formation of new blood vessels in the cornea, the two sequelae of herpes infection that are the cause of impaired vision and blindness. Further studies on the mechanism revealed that RX-10001 reduced both migration of leukocytes into the cornea, as well as dampening the formation of proinflammatory cytokines.
In a second study, Resolvyx and its collaborators evaluated RX-10001 in corneal cells exposed to a hyperosmolar environment, a common cause of corneal immune activation in dry eye patients. In this model system, treatment with RX-10001 prevented loss of tight junction function as a measure of preserved corneal barrier function and integrity. Another resolvin, RX-10045, has successfully completed a Phase 2 trial in patients with chronic dry eye syndrome.
A third study reported results from an animal model of wet age-related macular degeneration (wet AMD). Treatment with the preclinical development candidate RX-20001, the endogenous protectin NPD1, reduced microglial activation in the retinas of treated animals. The reduction in activated microglia was associated with a reduction in the formation of new pathological blood vessels, which is a major pathophysiological characteristic of wet AMD. The data suggest that NPD1 may improve association between perivascular cells and endothelial cells to stabilize new endothelial cells, leading to reduced vessel formation.
"These new findings further expand our understanding of the potential for resolvins to treat both corneal and retinal eye diseases, based on the unique ability of resolvins to naturally inhibit key inflammatory processes, preserve the integrity of eye tissue and promote tissue repair," said Per Gjorstrup, M.D., Ph.D., Chief Medical Officer of Resolvyx Pharmaceuticals. "Following our recent successful Phase 2 study in patients with chronic dry eye with RX-10045, we are very encouraged by these new data suggesting the broad clinical potential of resolvins beyond dry eye."
About Herpes Simplex Virus (HSV) Keratitis
HSV keratitis is the most frequent cause of corneal blindness in the United States and is a leading indication for corneal transplantation. HSV keratitis is also the most common cause of infectious blindness in the Western world. Once infected, the virus becomes latent in the carrier and the disease can be reactivated. Most HSV eye disease occurs in adults, and it occurs many years after the primary infection. Approximately 20,000 new cases of ocular HSV occur in the United States annually, and more than 28,000 reactivations occur annually with an estimated 500,000 people experiencing HSV-related ocular disease.
About Dry Eye Syndrome
Dry eye syndrome is one of the most common problems treated by eye physicians. An estimated 9 million Americans suffer from moderate to severe dry eye and an additional 20 to 30 million Americans have milder cases of dry eye,1 with worldwide prevalence of the disease closely paralleling that of the US. 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 AMD
Age-related macular degeneration (AMD) is a retinal degenerative disease that causes a progressive loss of central vision. AMD is the most common cause of vision loss in individuals over 55. An estimated 8 to 10 million people in the U.S. either have AMD or are at substantial risk of developing it, with 1.7 million suffering from advanced stage AMD. AMD causes deterioration of the macula in the eye, which is a tiny structure in the middle of the retina that is responsible for central vision.
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 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 (e.g. Crohn's disease, psoriasis and rheumatoid arthritis), allergic diseases (e.g. asthma) and chronic inflammatory diseases (e.g. 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. Resolvyx currently has two programs in clinical development. RX-10045 is a topical eye drop that has completed a Phase 2 trial in chronic dry eye. RX-10001 is formulated for oral delivery and has completed Phase 1.
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 over 80 patents and applications.
The company's headquarters are in Bedford, Massachusetts. For additional information, please visit http://www.resolvyx.com.