Athenagen, Inc., a privately held biopharmaceutical company, has begun testing ATG003, its topical (eye drop) therapy for age-related macular degeneration (AMD), in a phase I clinical trial.
ATG003 is a proprietary topical formulation of mecamylamine that has shown efficacy in animal models and is a possible alternative to current therapies for AMD, which require frequent needle injections directly in the eye. This study represents the first human study of an eye drop anti-angiogenic therapy for AMD, with a phase 2-efficacy study expected to follow early next year.
AMD is characterized by abnormal blood vessel growth in the eye, resulting in significant loss of vision. ATG003 is a novel anti-angiogenic agent that inhibits endothelial nicotinic acetylcholine (nACh) receptors and has been shown to decrease angiogenesis (new blood vessel growth) as well as vascular permeability, two well-known hallmarks of neovascular AMD. Athenagen's study is a randomized, placebo-controlled, ascending dose clinical trial designed to evaluate ocular tolerability and safety for up to 14 days
"Complementing our promising pre-clinical efficacy studies are robust data demonstrating excellent penetration of the drug to the back of the eye," stated M (Ken) Kengatharan, PhD., co founder and VP of Pre-clinical R&D at Athenagen. "Developed by our scientists, this proprietary eye drop formulation of mecamylamine enables delivery of drug to the retina and choroid with very little reaching the systemic blood circulation. The formulation has been well tolerated in preclinical safety models at all doses to be used in human testing."
There are approximately two million AMD patients in the US, and this disease is the number one cause of vision loss and legal blindness in adults over 60 in the US There is no cure for AMD and the standard-of-care is highly invasive, requiring needle injections directly in the eye every 4 to 6 weeks
"Given the prevalence of AMD and the invasive nature of current treatments, a topical non-invasive eye drop for treating this disease would be a welcome addition to our clinical arsenal," stated Michael Marmor, MD, Prof. of Ophthalmology, Stanford University School of Medicine.
"This is a significant advancement in the development of new medicines for AMD," commented W. Scott Harkonen, MD, President and CEO "We expect to generate data from our phase I study by the end of the year and plan to move directly into a larger safety and efficacy study in the first part of 2007."