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CoMentis Initiates Phase II Clinical Trial for AMD Eye Drop Therapy
South San Francisco, CA - april 10, 2007
CoMentis, Inc. (formerly Athenagen), a privately held biopharmaceutical company, announced today the initiation of a Phase II clinical study of ATG3, the company's topical eye drop therapy for neovascular age-related macular degeneration (NV-AMD). A proprietary ophthalmic formulation of mecamylamine, ATG3 is an antagonist of the nicotinic acetylcholine (nACh) receptor pathway that mediates angiogenesis. The drug was developed to effectively penetrate into the retina and choroid following topical eye drop administration.
This Phase II study is a double-masked,
randomized, placebo-controlled clinical trial designed to evaluate
the safety and efficacy of ATG3 in patients with NV-AMD (also
known as "wet' AMD). Approximately 330 patients will be randomized to one of three treatment groups, administered by eye drop twice daily: two different doses of ATG3 or placebo. One eye per patient will receive the study treatment. All patients will be treated for up to 48 weeks, during which time they will be monitored for safety, tolerability and efficacy assessments. Patients will be assessed for change in visual acuity and macular thickness using ocular coherence tomography.
"In January we completed our Phase I study of ATG3 in healthy volunteers and found excellent ocular safety following eye drop administration," said Henry Hsu, M.D., Chief Medical Officer of CoMentis. "We are very pleased to begin this international Phase II study as planned, and expect to have interim (six month) efficacy data by mid-2008. ATG3 could be the first topical angiogenic treatment for AMD and if approved, would compliment current therapies which require injection directly into the eye." Inhibition of the nicotinic acetylcholine (nACh) receptor pathway, which was discovered at Stanford by two of CoMentis'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 as well as reduction of new blood vessel growth in the eye.
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 CoMentis
CoMentis, Inc. has its headquarters in South San Francisco, with research operations in both South San Francisco and Oklahoma City. The company is engaged in the discovery and development of small-molecule drugs to treat Alzheimer's disease, age-related macular degeneration (AMD) and cognitive disorders. The company has two fundamental technology platforms: (i) aspartic protease inhibitors, including beta-secretase inhibitors for Alzheimer's disease; and (ii) nicotinic acetylcholine receptor (nAChR) agonists and antagonists for the treatment of angiogenesis mediated diseases and cognitive disorders.
Originally founded in 2004 as Athenagen,
Inc., the company was re-named CoMentis following the August
2006 merger with Zapaq, Inc., which created a leading neurovascular
disease franchise. Zapaq was founded in 2001 by Jordan Tang,
Ph.D., of the Oklahoma Medical Research Foundation, and Arun
Ghosh, Ph.D., now at Purdue University, both experts in the
field of aspartic proteases. Dr. Tang's groundbreaking discovery
of beta-secretase, an aspartic protease which is a critical
enzyme in beta amyloid production, was published in Proceedings
of the National Academy of Sciences in 2000.
CoMentis currently has three product development
programs based on its two technologies: ATG-3, a topical (eye
drop) anti-angiogenesis compound for neovascular AMD; CTS-21166,
an orally active beta-secretase inhibitor for Alzheimer's disease; and GTS-21, an oral agonist of the alpha-7 nACh receptor pathway for cognition enhancement.
For more information: www.comentis.com
CONTACT COMENTIS:
W. Scott Harkonen
M.D,President & CEO
Office (650) 869-7600
press@comentis.com
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