BERLIN, July 13, 2007 (PRIME NEWSWIRE) -- Jerini AG (FSE:JI4) announced today that the U.S. Food and Drug Administration (FDA) accepted the Investigative New Drug (IND) application submitted by Jerini's wholly-owned subsidiary, Jerini Ophthalmic, Inc., for JSM 6427 in the treatment of age-related macular degeneration (AMD). IND acceptance will allow Jerini Ophthalmic to begin Phase I testing of JSM 6427, currently planned for October 2007. JSM 6427 is a small molecule in development to prevent the progression of dry AMD to wet AMD, an unmet medical need affecting 600,000 patients in the United States. A product of Jerini's Peptides-to-Drugs (P2D) technology platform, JSM 6427 is being developed by Jerini Ophthalmic, which specializes in ophthalmologic disease indications.
"By addressing the angiogenesis, inflammation, and fibrosis that characterize the onset and progression of AMD, JSM 6427 could significantly advance the treatment of an increasingly prevalent disease," said Anthony P. Adamis, CEO and President of Jerini Ophthalmic. "Through the development of JSM 6427, we hope to reduce the vision loss and blindness associated with the progression of dry AMD to the wet form of the disease."
"The development of JSM 6427 exemplifies Jerini's ability to identify and develop novel compounds using our unique P2D platform," said Jens Schneider-Mergener, CEO of Jerini. "Jerini Ophthalmic's expertise will be instrumental in moving Jerini's ophthalmology programs forward and generating substantial value for the company."
About JSM 6427
A product of Jerini's P2D platform, JSM 6427 is the first small molecule alpha5beta1 integrin receptor antagonist of its kind to be developed. It has been biologically validated for therapeutic use in the prevention and treatment of wet AMD, the leading cause of blindness in people over the age of 55. In comparison to other therapies, JSM 6427 not only blocks angiogenesis induced by multiple growth factors such as VEGF (Vascular Endothelial Growth Factor), but also inhibits the effects of other growth factors and cytokines leading to angiogenesis, inflammation, and fibrosis. To address patient convenience as well as compliance, Jerini Ophthalmic is currently conducting preclinical tests using slow release formulations of JSM 6427 for AMD and other fibrotic eye diseases. JSM 6427 is also a promising potential drug candidate for combined use with other approved anti-VEGF therapies.
About Jerini Ophthalmic
Jerini's wholly-owned U.S. subsidiary, Jerini Ophthalmic, Inc., focuses on the rapid development of novel, highly specific therapeutics for eye diseases and extended-release formulations for chronic eye diseases. The company will further develop select compounds from Jerini's P2D technology platform, which target pathways associated with ophthalmic disease indications.
About Jerini
Jerini is a pharmaceutical company based in Berlin, Germany, focusing on the discovery, development, and commercialization of novel peptide-based drugs. The company pursues disease indications that have limited or no treatment options and has built a drug pipeline composed of its own programs, as well as others in collaboration with established partners. Jerini has completed Phase III clinical trials of Icatibant in the subcutaneous treatment of hereditary angioedema and plans to file marketing authorization applications with the FDA and European Medicines Agency in the third quarter of 2007. Based on its technology platform, Jerini has also established several in-house development programs, which address indications within the therapeutic areas of ophthalmology, oncology, and inflammatory diseases.
ISIN: DE0006787476