Suven completes SAD studies in phase 1 clinical trial for CNS drug

Suven Life Sciences Ltd has completed the single ascending dose (SAD) studies of SUVN-G3031 in healthy human volunteers and initiated multiple ascending dose studies (MAD) as a part of the phase I study currently ongoing in USA under US-IND 123179. SUVN-G3031 is a potent, selective, brain penetrant and orally active histamine H3 inverse agonist being developed for the treatment of cognitive dysfunction associated with Alzheimer’s disease and Schizophrenia.
 
The Phase-1 study was designed to evaluate the safety, tolerability and pharmacokinetics of SUVN-G3031 in healthy volunteers. The tolerability of SUVN-G3031 up to the highest dose administered in SAD study is excellent. No serious adverse events occurred. SUVN-G3031 demonstrated excellent pharmacokinetics with a potential for once in a day dosing.
 
“Histaminergic dysfunction has been strongly associated with the cognitive and behavioural deficits observed in several CNS disorders. Hence novel, potent, selective, brain penetrant and orally active H3 receptor inverse agonist for the treatment of cognitive deficits would offer new line of treatment for the unmet medical needs in Alzheimer’s disease, Schizophrenia and other CNS disorders,” said Suven Life Sciences in a press release.