Suven Life Sciences, a biopharma company focused on discovering, developing and commercializing novel pharmaceutical products, has presented clinical phase-I data for SUVN-502, its 5-HT6 antagonist drug candidate at the 2009 Alzheimer's Association International Conference on Alzheimer's disease (ICAD-2009) in Vienna, Austria. SUVN-502 is a potent, safe, highly selective, brain penetrant and orally active antagonist at a non-peripheral 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 was conducted at Basel under a clinical trial application (CTA) approved by SwissMedic, the regulatory authority of Switzerland for therapeutic products. The study is "a double-blind, placebo-controlled, randomized, both single ascending dose & multiple ascending dose study" in healthy male subjects.
The study was conducted on 67 healthy male subjects using escalating single and multiple oral doses with the objective of assessing safety, tolerability and pharmacokinetics of SUVN-502. The study demonstrated that SUVN-502 was well tolerated by the subjects at all dose levels and was found to have a dose proportional pharmacokinetics profile with good exposure levels. There were no clinically significant changes of vital sign parameters, no serious or significant adverse events, including no cardiovascular effects seen either in single dose or the multiple dose cohorts. In the phase-I studies, high exposure levels of the drug were reached, which exceeded by several folds the levels required for efficacy in various in vivo acute and chronic models in animals. The detailed pharmacokinetics of the SUVN-502 was studied from the blood samples drawn up to 120-hour post-dosing. SUVN-502 demonstrated very favourable pharmacokinetics with a potential for once in a day dosing.
"We are very pleased with the results of phase-1 single ascending & multiple ascending studies with SUVN-502 in Switzerland. The phase-1 clinical data attracted a lot of scientific and commercial interest from global pharma companies. SUVN-502 produces a robust effect in key models of cognition with a favourable safety and pharmacokinetic profile, providing a strong rationale for clinical development in a cognition indication. We believe that SUVN-502 has great potential to become a novel treatment for disorders affecting memory and cognition in Alzheimer's, Schizophrenia and other dementia", says Venkat Jasti, CEO of Suven Life Sciences.
"The outcome of the phase-I study is very much in-line with our predictions from the pre-clinical PK, safety and Tox studies. SUVN-502 is a very safe molecule and has demonstrated to be highly potent, safe and orally available with good bioavailability across species tested. The molecule also exhibited excellent selectivity over other targets. The necessary additional Tox studies are already in progress to start the phase-II proof-of-concept (POC) study during 2010. The company targets launching of SUVN-502 in later part of 2013 or early part of 2014. Other molecules in the same category currently under development include GSK's molecule presently in phase II", says Dr Ramakrishna Nirogi, VP, discovery research, Suven Life Sciences.
The company has six internally discovered therapeutic drug candidates currently in pre-clinical stage of development targeting conditions such as ADHD, dementia, depression, Huntington's disease. Parkinson's disease and obesity are in addition to developmental candidates in Alzheimer's disease and Schizophrenia.