Hyderabad, India April 9, 2009 - Suven Life Sciences Ltd, a Drug Discovery and development company announced today that it 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 disease, Schizophrenia and other disorders of memory and cognition like Attention deficient hyperactivity disorder (ADHD), Parkinson. Suven would present the results from the Phase-1 program 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-I trials of SUVN-502. This is a significant development for our organization as this molecule is our first 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 new benchmarks in speed, efficiency and continuous progress in the drug discovery space” says Ramakrishna Nirogi, Vice President, Discovery Research, Suven Life Sciences.
Suven Life Science is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products, which are first in class or best in class therapies through the use of GPCR targets. The Company has six internally discovered therapeutic drug candidates currently in clinical and pre-clinical stage of development targeting conditions such as ADHD, dementia, and depression, Huntington’s disease. Parkinson’s disease and obesity are in addition to developmental candidates in Alzheimer’s disease and Schizophrenia.
Risk Statement:
Except for historical information, all of the statements, expectations and assumptions, including expectations and assumptions, contained in this news release may be forwardlooking statements that involve a number of risks and uncertainties. Although Suven attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. Other important factors which could cause results to differ materially including outsourcing trends, economic conditions, dependence on collaborative partnership programs, retention of key personnel, technological advances and continued success in growth of sales that may make our products/services offerings less competitive.
