Potentia Pharmaceuticals' Drug Candidate For Age Related Macular Degeneration Shows Positive Safety Profile In Phase I Clinical Trial

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 11 Nov 2008 - 0:00 PDT

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Potentia Pharmaceuticals, a privately held biotechnology company developing medicines for the treatment of age-related macular degeneration (AMD), presented Phase I data last week during the Retina Subspecialty Day at the American Academy of Ophthalmology (AAO) Annual Meeting in Atlanta, GA. The data was from the ASaP (Assessment of Safety of Intravitreal POT-4 Therapy for Patients with Neovascular Age-Related Macular Degeneration) clinical trial for the company's leading drug candidate, POT-4, which is being developed for the treatment of AMD.

The ASaP trial is a first-in-man, multi-center, single escalating dose study. The interim results of this trial revealed no drug-related toxicity based on clinical signs, ophthalmic examinations, or laboratory results at any time point monitored in patients treated with up to 150 microgram/dose of POT- 4. Additionally, no serious adverse events and no identifiable intraocular inflammation were reported.

Preliminary results indicate that intravitreal POT-4 is safe, and the data accumulated so far support the continued investigation of POT-4 for the treatment of both dry and wet AMD with larger randomized clinical trials to further define its efficacy profile.

"These safety data strongly support the further development of POT-4 as a potential treatment for patients with AMD," said Cedric Francois, President and CEO of Potentia Pharmaceuticals. "We believe that the product has significant promise based on these early-stage findings and look forward to further testing of the compound in higher doses as we continue this trial."

About POT-4

POT-4 is a complement inhibitor, which shuts down the complement activation cascade that could otherwise lead to local inflammation, tissue damage and upregulation of angiogenic factors such as vascular endothelial growth factor (VEGF) in the eye. Based on this mechanism of action, POT-4 holds the potential to be effective against both dry and wet AMD.

About AMD

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 (MAC). 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 destructive consequences if left unchecked. Over the past three years, multiple scientific publications have strongly linked variants of genes encoding components of the complement system with a predisposition toward AMD.

POT-4 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 downstream complement activation that could otherwise lead to local inflammation, tissue damage and upregulation of angiogenic factors such as vascular endothelial growth factors (VEGF).

About Potentia

Potentia Pharmaceuticals, Inc. is an early stage biotechnology company focused on developing novel therapeutics and drug delivery technologies to address chronic inflammatory diseases, with an initial emphasis on diseases of the eye such as age-related macular degeneration.

Potentia Pharmaceuticals, Inc.
http://www.potentiapharma.com