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Othera Pharmaceuticals Announces First U.S. Patent Issued On New Class of Compounds to Treat AMD and Other Ophthalmic Diseases
Wednesday, October 29, 2008
Exton, PA -- Othera Pharmaceuticals, Inc., a specialty pharmaceuticals company focused on novel, patient-administered products for ophthalmic disease, has today announced the U.S. Patent and Trademark Office (PTO) issued to Othera the first patent covering a broad class of disubstituted hydroxylamine small molecules that target oxidative stress and inflammation pathways believed to be involved in age-related macular degeneration (AMD) and other diseases of the eye. U.S. Patent No. 7,442,711 covers several new chemical entities, including composition of matter and use of the company's lead product candidate, OT-551. David Joseph, Othera's Chairman and CEO, commented, "We are quite pleased that the PTO has issued this important patent to protect our OT-551 intellectual property estate." With anticipated patent life extensions, the patent is expected to be valid through at least 2024.
OT-551 is a topically-dosed, novel small molecule that inhibits oxidative stress and disease-induced inflammation. The company has completed enrollment of a Phase 2 clinical trial of OT-551 for the treatment of an advanced form of dry age-related macular degeneration, also termed geographic atrophy (GA). Experts believe that both oxidative stress and inflammation contribute to the progression of GA in patients. In preclinical studies of retinal disease, OT-551 has been shown to reach the back of the eye in efficacious amounts after topical dosing, and has demonstrated excellent safety to date, providing the key rationale for studying the drug in patients with GA.
"We believe that the completion of the enrollment in the Phase 2 OT-551 (OMEGA) study is a significant milestone for OT-551's development program in GA," commented Dr. Al Reaves, Sr. VP of Clinical Development. "We are very encouraged by preclinical research results demonstrating OT-551's potential to treat GA, one of the leading causes of vision loss and legal blindness. Two Phase 2 trials of OT-551 in GA patients are currently underway and we expect results of an interim analysis in the spring of 2009."
The OMEGA (OT-551 Multi-center Evaluation of Geographic Atrophy) study is a randomized, double-masked, dose-ranging, multi-center, Phase 2 study comparing the safety and efficacy of OT-551 with placebo to treat GA associated with age-related macular degeneration. One hundred and thirty-seven (137) patients have been enrolled in 20 leading retinal disease treatment centers across the U.S. into this 24-month study.
About Geographic Atrophy (GA)
Geographic atrophy (GA) is the most advanced and severe form of dry age-related macular degeneration (AMD). GA is caused by the gradual loss of the cells in the retina primarily responsible for central vision. Central vision allows for important tasks such as driving, reading, and identifying faces. As is the case with the "wet" form of AMD, roughly 1 million Americans have GA, and many of these cases will end in legal blindness. Unlike wet AMD, however, the damage to the retina from GA is irreversible. There are currently no FDA-approved drug treatments for GA.
About Othera Pharmaceuticals
Founded in 2002, Othera Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing novel, patient-administered products for ophthalmic disease.
In addition to OT-551, Othera recently filed an IND for a second product, OT-730, a novel topical treatment for glaucoma with the promise of improved safety over current therapies. A proof-of-concept study on IOP reduction versus the most widely-prescribed beta-blocker (timolol) is currently underway and expected to complete by the end of 2008.
For information please visit Othera's website at www.othera.com.
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