Suven Life Sciences Ltd, a drug discovery and development company, has completed its phase-1 multiple ascending dose study of SUVN-502 in healthy volunteers. SUVN-502 is 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 disorder (ADHD), Parkinson. Suven would present the results from the phase-1 programme at the International Conference on Alzheimer's Disease (ICAD) at Vienna, Austria during July-2009.
The tolerability of SUVN-502 up to the highest dose administered is excellent. No serious adverse events occurred. No clinically significant changes or study medication related abnormalities were observed with respect ECGs and laboratory evaluations. There were no clinically significant changes of vital sign parameters. The detailed pharmacokinetics of the SUVN-502 was studied from the blood samples drawn up to 120 hours post-dosing on the last day of multiple dose treatment. SUVN-502 demonstrated excellent pharmacokinetics with a potential for once in a day dosing.
Patent has been granted to SUVN-502 in several countries around the globe with validity until 2023. Suven is in discussions with 8 potential licensing partners for this compound. Timing of the licensing would depend on the deal terms and ability to move the molecule to next level of clinical studies.
In a parallel process Suven is gearing up its resources and working out the plans to initiate the POC studies (phase-2a) during the last quarter of 2009. The company anticipates that SUVN-502 can be launched in the major regulated markets by 2013.
Speaking on this development, Venkat Jasti, CEO Suven Life Sciences Ltd said, "We are extremely glad with the outcome of the phase-1 trial of SUVN-502. This is a significant development for out organization as this molecule is our fist invention and has a potential to be first-in-class and best in class for the treatment of Alzheimer's disease and other disorders of memory viz Schizophrenia, Parkinson's and ADHD etc."
"This development is a reaffirmation of Suven's research capabilities and focused approach towards drug discovery and our commitment towards setting now benchmarks in speed, efficiency and continuous progress in the drug discovery space," says Ramakrishna Nirogi, vice president, discovery research, Suven Life Sciences.