Suven Life Sciences’ NCESUVN-911, a potent, selective, brain penetrant and orally active, novel chemical entity intended for the treatment of major depressive disorder (MDD) has initiated Phase 1 development and first dosing under US IND 133850 and the topline results from the study is expected during the quarter Jan-March 2018.
SUVN-911, a neuronal nicotinic alpha-4-beta-2 receptor, a unique class of protein is expressed at high level in brain. It regulates vital biological functions that are impaired in Major Depressive Disorders (MDD).
Preclinical studies in animal models suggest that SUVN-911 has a faster onset of action, unlike the conventional antidepressants. In addition it is also devoid of sexual side effects and also improves the cognitive skills which are the major side effects of current antidepressant therapy. SUVN-911 has completed all the preclinical, safety, early tox and GLP tox studies.
Suven life science submitted Investigational New Drug Application (IND) to conduct Phase 1 clinical trial for MDD, under 505(1) of the Federal Food, Drug and Cosmetic Act (FDCA, USA). SUVN-911 was assigned an IND number 133850. Based on the US IND ‘A single-center, double-blind, placebo-controlled, randomized, Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of SUVN-911 after single ascending doses (SAD) and multiple ascending doses (MAD) in healthy male subjects” has been initiated in USA.