Suven Life Sciences Ltd, a bio-pharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products, has completed the phase-I single ascending dose study of SUVN-502 in healthy subjects. 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, Switzerland 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, single ascending dose study" in healthy male subjects.
The tolerability of SUVN-502 up to the highest dose administered is very good. No serious adverse events occurred. No clinically significant changes or study medication related abnormalities were observed with respect ECGs and lab 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 72 hours 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 study with SUVN-502 in Switzerland. 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. SUVN-502 is the first NCE of Suven to enter the clinic from a pipeline of 6 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.
"The outcome of the phase-I study is very much in-line with our predictions from the pre-clinical studies. SUVN-502 is a very safe molecule and has demonstrated to be highly potent, safe and orally available with good bio-availability across species tested. The molecule also exhibited excellent selectivity over other targets", says Dr Ramakrishna Nirogi, VP, Discovery Research, Suven Life Sciences.