Suven Life Sciences Ltd Announces Initiation Of Phase I Clinical Trial And First Dosing Of SUVN-911, A Neuronal Acetylcholine Nicotinic Receptor (Nachrs) Antagonist For Major Depressive Disorder (MDD)
HYDERABAD, INDIA (May 25, 2017) – Suven Life Sciences today informed that their 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.
“Progression of SUVN-911 into Phase 1 clinical development is a significant achievement in enhancing our clinical pipeline beyond Dementia into mental illness arena, Major Depressive Disorder (MDD)”, said Venkat Jasti, CEO of Suven Life Sciences.
Mental illness is a leading cause of disability globally. Depression alone affects almost 121 million people worldwide. Nearly 5-10% people in a community at any given time are in need of intervention and about 8-20% people carry the risk of depression during their life time. Current treatments are marred by poor efficacy (longer time for onset of efficacy) and side effects (sleep disturbances, cognitive dulling and sexual dysfunction). Global antidepressant market is valued over $ 20 billion. Serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed class of drugs for depression, but many patients fail to respond adequately.
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.
"We are very pleased that the fourth compound from our pipeline of molecules in CNS has moved into clinical trial that is being developed for Major Depressive Disorder (MDD) , a high unmet medical need which has huge market potential globally” says Venkat Jasti, CEO of Suven.
About 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 CNS therapies using GPCR targets. Suven has 4 clinical stage compounds, a Phase 2 undergoing SUVN-502, Phase 2 ready SUVN-G3031 and Phase 1 completed SUVN-D4010 for Alzheimer’s disease and Schizophrenia.
SUVN-911 is the 4th developmental molecule from Suven’s drug discovery pipeline with proprietary intellectual property (Patents) and US IND. In addition to these clinical compounds the Company has nine (9) internally-discovered therapeutic drug candidates currently in various stages of pre-clinical development targeting conditions such as ADHD, dementia, depression, Huntington’s disease, Parkinson’s disease and pain.
For more information please visit our Web site at http://www.suven.com
“Progression of SUVN-911 into Phase 1 clinical development is a significant achievement in enhancing our clinical pipeline beyond Dementia into mental illness arena, Major Depressive Disorder (MDD)”, said Venkat Jasti, CEO of Suven Life Sciences.
Mental illness is a leading cause of disability globally. Depression alone affects almost 121 million people worldwide. Nearly 5-10% people in a community at any given time are in need of intervention and about 8-20% people carry the risk of depression during their life time. Current treatments are marred by poor efficacy (longer time for onset of efficacy) and side effects (sleep disturbances, cognitive dulling and sexual dysfunction). Global antidepressant market is valued over $ 20 billion. Serotonin reuptake inhibitors (SSRIs) are the most commonly prescribed class of drugs for depression, but many patients fail to respond adequately.
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.
"We are very pleased that the fourth compound from our pipeline of molecules in CNS has moved into clinical trial that is being developed for Major Depressive Disorder (MDD) , a high unmet medical need which has huge market potential globally” says Venkat Jasti, CEO of Suven.
About 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 CNS therapies using GPCR targets. Suven has 4 clinical stage compounds, a Phase 2 undergoing SUVN-502, Phase 2 ready SUVN-G3031 and Phase 1 completed SUVN-D4010 for Alzheimer’s disease and Schizophrenia.
SUVN-911 is the 4th developmental molecule from Suven’s drug discovery pipeline with proprietary intellectual property (Patents) and US IND. In addition to these clinical compounds the Company has nine (9) internally-discovered therapeutic drug candidates currently in various stages of pre-clinical development targeting conditions such as ADHD, dementia, depression, Huntington’s disease, Parkinson’s disease and pain.
For more information please visit our Web site at http://www.suven.com