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Athenagen’s Eye
Drop Therapy for AMD
is Safe and Well Tolerated in Phase I
Study
SOUTH SAN FRANCISCO
, CA – JANUARY 31, 2007
Athenagen, Inc., a privately held
biopharmaceutical company focused in the area of neurovascular
diseases, announced today the completion of a Phase I clinical
study of ATG3, the company’s
topical eye drop therapy for neovascular age-related macular
degeneration (AMD). ATG3, a proprietary ophthalmic formulation
of mecamylamine, is an antagonist of the nicotinic acetylcholine
(nACh) receptor pathway that mediates angiogenesis. Inhibition
of this pathway, which was discovered at Stanford by Athenagen’s
founding scientists, also down regulates vascular endothelial-derived
growth factor (VEGF) dependent angiogenesis. Studies in animal
models have demonstrated excellent penetration of the proprietary
ATG3 formulation to the retina and choroid following eye drop
application.
ATG3 was evaluated in a randomized, double-masked, placebo-controlled
Phase I study which enrolled 80 healthy volunteers in single
and multiple dose ascending regimens for up to 14 days of therapy.
Subjects received study medication by eye drop twice daily.
The primary endpoint was ocular and systemic safety and included
detailed ocular slit lamp examination.
“ATG3 is the first non-invasive eye drop therapy for
AMD that has entered the clinic and we are extremely pleased
with the safety data from this study,” commented Henry
Hsu, MD, Athenagen’s Chief Medical Officer. “The
eye drop therapy showed excellent ocular tolerability. There
were no study medication-related systemic side effects, consistent
with the very low levels of the compound found in the blood
following eye drop application. The safety profile observed
allows us to advance into a large Phase II study in patients
with neovascular AMD.”
Athenagen’s Phase II clinical
trial, which is expected to begin this quarter, is a placebo-controlled,
double-masked, randomized dose-ranging study designed to
evaluate both safety and efficacy in patients with neovascular
AMD (also known as wet AMD). The 330-patient study will be
conducted at multiple centers worldwide. Athenagen expects
to have interim (six month) efficacy data by mid-2008.
About AMD
AMD occurs when abnormal blood
vessels behind the retina start to grow under the macula, the
light-sensitive tissue at the back of the eye. These new blood
vessels tend to be very fragile and often leak blood and fluid.
The blood and fluid raise the macula from its normal place
at the back of the eye and lead to loss of central vision,
often quite rapidly. Although it rarely causes total blindness,
AMD robs those affected of their sharp central vision required
for most daily visual activities. It destroys the clear, “straight ahead” central
vision necessary for reading, driving, identifying faces, watching
television, doing fine detailed work, safely navigating stairs
and performing other daily tasks. Approximately two million
patients in the U.S. suffer from neovascular AMD and this number
is expected to grow with an aging population.
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 in 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 in a Phase I/II
study; and multiple clinical candidates from the beta-secretase
inhibitor program approaching Phase I/II study for Alzheimer’s
disease in 2007.
For more information: www.athenagen.com.
CONTACT:
W. Scott Harkonen, M.D.
President and CEO
(650) 869-7600
press@athenagen.com
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