Potentia Pharmaceuticals Announces Initiation of Phase I Clinical Trials to Evaluate its Lead Compound for Age-Related Macular Degeneration

POT-4 is the first complement inhibitor for age-related macular degeneration to enter clinical phase of development.

LOUISVILLE, KY, USA | Mar 20, 2007 |
Potentia Pharmaceuticals, Inc. announced today that it is entering the clinical phase of development for POT-4, its lead drug candidate for the treatment of age-related macular degeneration (AMD). POT-4 is a complement inhibitor, which shuts down the complement activation system that could lead to local inflammation, tissue damage and upregulation of angiogenic factors such as vascular endothelial growth factor (VEGF).

Four landmark studies published in April 2005 demonstrated a genetic link between the complement system and AMD, providing evidence that complement activation plays a significant role in the cause of the disease. Less than two years after the publication of the studies, POT-4 will be the first complement inhibitor tested in patients with AMD.

"These recent data have sparked hope that AMD can be treated with complement inhibitors, which help treat the early stages of the disease. We are hopeful that POT-4 may represent a new therapeutic option for patients with dry and wet forms of the disease," said Cedric Francois, M.D., Ph.D., Potentia's President and CEO.

AMD is the leading cause of blindness in the elderly of the western world and affects more than 10 million patients in the United States alone. The current standard of care for AMD relies primarily on angiogenesis inhibitors, an approach geared towards the approximately 10-15% of AMD patients with complications resulting from ocular angiogenesis (growth of new blood vessels and bleeding in the back of the eye). No drug currently on the market has been approved for the treatment of the remaining patients, who suffer from the so-called "dry" form of the disease.

About the Complement System and POT-4

Complement activation is an inflammatory process involving dozens of plasma proteins, ultimately leading to cell membrane disruption through the membrane attack complex. Activation of the complement system is an important part of the body's defensive immune response against pathogens such as bacteria and viruses. In spite of its defensive function, inappropriate or excessive complement activation can have pathological consequences. Multiple studies published over the past 2 years have strongly linked the complement system to the pathology of AMD.

POT-4 is a synthetic peptide discovered by Professor John Lambris at the University of Pennsylvania. It binds tightly to complement component C3, preventing its participation in the complement activation cascade. As C3 is the central component of all major complement activation pathways, its inhibition effectively shuts down all downstream complement activation that could otherwise lead to local inflammation, tissue damage and upregulation of angiogenic factors such as vascular endothelial growth factor.

About Age-Related Macular Degeneration

AMD is the progressive deterioration of the critical central region of the retina called the macula. This disorder leads to irreversible loss of central vision. More than 25 million patients worldwide suffer from AMD, including roughly one-quarter of those 70 years and older. Ten to fifteen percent of patients with AMD develop a complication in which leaky blood vessels grow into the retina. This form of the disease is referred to as 'neovascular' or 'wet' AMD, as opposed to 'atrophic' or 'dry' AMD when this complication does not emerge. Pharmacological treatments of AMD are primarily limited to drugs that inhibit blood vessel growth and leakage and are therefore approved for use only in patients with wet AMD.

About Potentia's AMD Program

With the ultimate goal of making AMD a preventable disease, Potentia's AMD program focuses on developing new therapies that target AMD early in the disease process. Potentia's AMD pipeline includes POT-4 formulated to protect patients from the disease for prolonged periods of time after each treatment.

About Potentia Pharmaceuticals, Inc.

Potentia Pharmaceuticals, Inc. (http://www.potentiapharma.com) is a privately held, biotechnology company based in Louisville, KY. Together with its corporate and academic partners, Potentia is developing new approaches to the treatment of complement-related inflammatory diseases such as AMD.

SOURCE: Potentia Pharmaceuticals, Inc.

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