Othera Pharmaceuticals Announces Results from First Human Phase I Trial For OT-551.
Topical Eye Drop Antioxidant Therapy Targets Oxidative Damage Leading to the Most Common Form of Cataracts Study meets all safety and comfort endpoints and positions Othera to move forward with planned Phase II study later in 2005
Othera Pharmaceuticals, Inc. today announced that its Phase I Safety and Comfort Study of OT-551, a topical eye drop pharmaceutical, met its primary endpoints. Othera Pharmaceuticals is a privately-held ophthalmic pharmaceutical company developing proprietary drugs to treat or prevent the leading causes of blindness. Following on these positive Phase I results, Othera plans to initiate a Phase II clinical trial to study OT-551's ability to slow or halt the development of a type of nuclear cataract, which is considered to be the most common form of age-related cataract. That study, set to begin in the second half of 2005, will involve 100 patients who will receive treatment over a 12 month period.
"The positive results from the Phase I trial represent a significant milestone for Othera, positioning us to move forward with our planned Phase II study for cataracts and to pursue other ophthalmic indications for OT-551. Chief among these other potential applications is the treatment of age-related macular degeneration," said David S. Joseph, chairman and CEO of Othera.
Othera intends to file a supplement to its OT-551 Investigational New Drug (IND) application with the FDA for use of OT-551 as a treatment for age-related macular degeneration (AMD) in 2006. Separately, the company plans to file another IND in 2006 for OT-730, a second eye drop product, currently in preclinical development as a treatment for glaucoma.
Othera will present at the BIO2005 meeting, to be held in Philadelphia from June 19-22.
About the Company
Othera Pharmaceuticals, Inc. (www.othera.com) is a privately-held, ophthalmic pharmaceutical company located in Exton, Pennsylvania. Othera is developing proprietary drugs to treat or prevent the three leading causes of blindness and vision impairment in the world - cataracts, age-related macular degeneration (AMD) and glaucoma. The Company's lead drug, OT-551, is a potent antioxidant topical eye drop to prevent the development of cataracts and AMD. With age, ocular levels of natural antioxidants, such as vitamins and enzymes, tend to decrease over time, leaving the eye susceptible to oxidative damage and disease. OT-551 mimics some of these natural compounds, but owing to its chemistry and catalytic nature, has demonstrated high antioxidant activity at low levels in preclinical studies of both cataract and AMD disease models. Othera's second drug, OT-730, is a novel beta blocker-like eye drop treatment for glaucoma that is designed to provide the same efficacy as current glaucoma therapies, but without the systemic side effects normally associated with this drug class.
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|Date:||May 25, 2005|
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