Biotech Values

[DewDiligence]

Athenagen Initiates Phase-1 Trial of Eye Drop for AMD

[If this drug works, the delivery method will obviously be preferable to that of AMD drugs currently on the market including, of course, Lucentis. The drug’s purported MoA—inhibiting the nicotinic acetylcholine (nACh) receptor—is one that has been tested in Alzheimer’s disease and, not surprisingly, Alzheimer’s is a focus of this private company. Oral mecamylamine (Inversine from Targacept) is approved for hypertension and has been tested as a treatment for depression and smoking cessation.]

http://biz.yahoo.com/prnews/060821/sfm027.html?.v=61

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Monday August 21, 8:00 am ET

SOUTH SAN FRANCISCO, Calif., Aug. 21 /PRNewswire/ -- Athenagen, Inc., a privately held biopharmaceutical company, said today that it 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, Ph.D., 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 United States, and this disease is the number one cause of vision loss and legal blindness in adults over 60 in the U.S. 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, M.D., Professor of Ophthalmology, Stanford University School of Medicine.

"This is a significant advancement in the development of new medicines for AMD," commented W. Scott Harkonen, M.D., President and Chief Executive Officer. "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."

…About Athenagen

Athenagen, Inc., located in South San Francisco, is engaged in the discovery and development of small-molecule drugs to treat neurovascular disease indications, such as Alzheimer's disease, AMD and cognitive disorders. The company has two fundamental technology platforms: (i) beta-secretase inhibitors for the treatment of Alzheimer's disease; and (ii) nACh receptor agonists and antagonists for the treatment of angiogenesis mediated diseases and cognitive disorders. Athenagen currently has four product development programs based on these two technologies: ATG003, a topical (eye drop) anti- angiogenesis compound for neovascular AMD entering a Phase I study; GTS-21, an oral agonist of the alpha-7 nACh receptor pathway for cognition enhancement currently in a Phase II study; ATG002, a topical (gel) pro-angiogenesis compound for diabetic foot ulcers currently under an active IND and ready for Phase I/II study; and two clinical candidates from the beta-secretase inhibitor program approaching Phase I study for Alzheimer's disease in the first quarter of 2007. For more information: www.athenagen.com.
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