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Saegis Pharmaceuticals, Inc. Completes Phase I Clinical Study Of SGS518


10/19/2005 5:13:09 PM

HALF MOON BAY, Calif., March 29 /PRNewswire/ -- Saegis Pharmaceuticals, Inc., a biopharmaceutical company focused on developing medicines that protect and enhance memory and cognition, today announced the successful completion of a Phase I clinical study of SGS518. SGS518 is being developed as a treatment for Cognitive Impairment Associated with Schizophrenia (CIAS).

The primary objective of the Phase I study was to evaluate safety and tolerability, as well as the pharmacokinetics, of SGS518. The placebo-controlled, blinded study was conducted among healthy volunteers in two cohorts, including a dose-ranging arm, followed by a multi-dose study. The conclusion of both arms of the Phase I study found SGS518 to be safe and well tolerated.

"This was a first-in-man study with a new chemical entity and we are very pleased with the positive safety data obtained for SGS518. These data provide valuable direction for our Phase II clinical program," said Rodney Pearlman, Ph.D., President and CEO of Saegis. "Currently, there are few, if any, therapies available for individuals suffering from Cognitive Impairment Associated with Schizophrenia and our intention is to evaluate the efficacy of SGS518 in this patient population. It is hoped that an effective treatment for the cognitive impairment in schizophrenia will help patients lead more normal and productive lives."

SGS518 is a selective antagonist of the 5-Hydroxytryptamine-6 (5-HT6) serotonin receptor believed to act by enhancing transmission of chemicals in the brain. Prior preclinical evaluation of SGS518 has shown it to be effective in behavioral studies of learning and memory. Saegis is developing SGS518 in cooperation with Eli Lilly and Company as a treatment for CIAS. Schizophrenia affects an estimated two million people in the United States and a large proportion of these patients are believed to also suffer from cognitive impairment. While currently marketed drugs are often effective in treating the psychoses that characterizes schizophrenia, CIAS remains a significant unmet need, preventing controlled patients from leading normal lives.

SGS518 is the third compound under clinical evaluation by Saegis. The company's lead compound, SGS742, is currently in multi-center, randomized Phase II clinical studies for mild to moderate Alzheimer's disease. SGS742 is also being evaluated in a Phase II placebo-controlled, double-blind crossover study for adult Attention Deficit Hyperactivity Disorder (ADHD). In addition, Saegis has studied SGS111, a memory enhancing drug intended for use as a neuroprotective agent to minimize the detrimental cognitive impact associated with Coronary Artery Bypass Grafting (CABG) surgery.

About Saegis Pharmaceuticals

Saegis Pharmaceuticals is a pioneer in the development of medicines that protect and enhance the function of the human mind. Saegis is building a portfolio of compounds for the treatment of neurological conditions that impact memory and cognition, including Alzheimer's disease, adult attention deficit hyperactivity disorder (ADHD), mild cognitive impairment and Cognitive Impairment Associated with Schizophrenia (CIAS). Currently, the company has three orally-available small molecule compounds in clinical development, two of which have already demonstrated efficacy and safety in humans. Saegis' product pipeline is fueled by the discovery and identification of high-value leads leveraging comparative modeling technology of age-related cognitive decline, coupled with the strategic in-licensing and repositioning of promising clinical-stage compounds. Privately held, Saegis has received investment support from Versant Ventures, Technology Partners, Sofinnova Ventures (U.S.), Sofinnova Partners (Paris), Polaris Venture Partners, NeuroVentures, the Stanley Medical Research Institute and Novartis Pharma AG. For more information, visit http://www.saegispharma.com/.

Saegis Pharmaceuticals, Inc.

CONTACT: Jack Anthony of Saegis Pharmaceuticals, Inc., +1-650-560-0210,ext. 259, or janthony@saegispharma.com; or Karen L. Bergman, +1-650-575-1509,or Michelle Corral, +1-415-794-8662, both of BCC Partners, for SaegisPharmaceuticals, Inc.


Read at BioSpace.com


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