Suven Life Sciences Initiates Phase I Clinical Trials in Europe of SUVN-502 for Alzheimer’s Disease

Suven Life Sciences Ltd announced at Bio-2008, San Diego that they commenced Phase I clinical trials of SUVN-502, a potent, safe, highly selective, brain penetrant and orally active antagonist at a nonperipheral CNS receptor site 5-HT6, intended for the symptomatic treatment of Alzheimer’s disease and other disorders of memory and cognition like Attention deficient hyperactivity, Parkinson, Schizophrenia.

Stimulation of 5-HT6 receptors in the brain has been shown to increase the release of acetylcholine and glutamate levels and has shown activity in several animal models with cognitive-enhancing properties of memory impairment.

The study is being conducted at Basel, Switzerland under a Clinical Trial Application (CTA) approved by SwissMedic, the regulatory authority of Switzerland.

The Phase I study being conducted using single and multiple oral doses with the objective of assessing safety and bioavailability of SUVN-502 in 67 healthy human beings. The single ascending dose (SAD) studies are expected to be complete by Sept-2008 and multiple ascending dose (MAD) studies are to be conducted during Oct-Dec 2008.

"SUVN-502 is an exciting molecule which fared very well in preclinical studies and the first NCE of Suven to enter the clinic from a pipeline of six NCEs. The CNS market and especially the cognition is amongst the largest, about $20 billion potential market opportunity globally and this novel target presents an excellent opportunity," says Venkat Jasti, CEO of Suven Life Sciences Ltd.

"Pre-clinical studies have demonstrated SUVN-502 to be highly potent, safe and orally available with good bioavailability across species tested. The molecule also exhibited excellent selectivity over other targets. We believe that SUVN-502 has great potential to become a novel treatment for disorders affecting memory and cognition in Alzheimer’s and other dementia” says Dr. Ramakrishna Nirogi, Vice President, Discovery Research, Suven Life Sciences.