Suven Life Sciences Ltd, a drug discovery and development company has 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.
The study is being conducted at Basel, Switzerland under a clinical trial application (CTA) approved by SwissMedic, the regulatory authority of Switzerland. The study is expected to be completed by Dec 2008. 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 the lead compound, selected from a series of more than 500 compounds, which were innovatively designed and developed using the combination of traditional and rational medicinal chemistry approaches.
Announcing this Venkat Jasti, CEO of Suven Life Sciences Ltd., "SUVN-502 is an exciting molecule and the first NCE of Suven to enter the clinic from a pipeline of six NCEs. The CNS market and especially the cognition are amongst the largest, about $20 billion potential market opportunity globally and this novel target presents an excellent opportunity".
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 thus providing symptomatic benefit. Significantly, a presentation of the preclinical data pertaining to SUVN-502 will be made at the forthcoming International Conference on Alzheimer's disease (ICAD), to be convened in July this year at Chicago, USA.
Dr Ramakrishna Nirogi, vice president, discovery research, Suven Life Sciences stated that pre-clinical studies have demonstrated SUVN-502 as 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.
Suven is also in discussions for potential licensing partners for this compound. Timing of the licensing would depend on the deal terms and ability to get co-promotion rights in some of the regulated markets. The company targets launching the molecule in 2012 and aims to be an early launcher in this class. Other molecules in the same category currently under development include GSK's molecule presently in phase II.