The first new drug for depression is expected to be born in 20 years
December 08, 2017 Source: WuXi PharmaTech
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Sage Therapeutics today published data from Phase 2 clinical trials of SAGE-217, which showed positive top-line results in 89 adult patients with moderate to severe depression (MDD).
Major depression is a common but serious emotional disorder in which a patient exhibits depression or has lost pleasure in daily activities for at least two weeks and has an obstacle to social, professional, educational or other important activities. It is estimated that about 16 million people in the United States suffer from these diseases each year. Although antidepressants are widely used in treatment, large-scale studies have proven that patients need additional treatment.
SAGE-217 is the next generation of forward allosteric modulators optimized for the selectivity of synaptic and extrasynaptic GABA receptors and the pharmacokinetic profile of daily oral administration. The GABA system is the main inhibitory signaling pathway in the brain and central nervous system, and is important for regulating central nervous system function. SAGE-217 is currently being developed for MDD and certain other mood and movement disorders.
â–² SAGE-217 is expected to be used for the treatment of various diseases (Source: Sage official website)
In a randomized, double-blind, parallel-group, placebo-controlled trial, 89 eligible patients (with a minimum of HAM-D total score of 22 on the Hamilton Depression Scale) were randomized to receive SAGE-217 capsules (30 mg) in a 1:1 ratio. (n = 45) or matching placebo (n = 44). All doses of study drug were administered with food at night. The study included a 14-day treatment period and a 4-week follow-up period. The mean HAM-D score was 25.2 in the SAGE-217 group and 25.7 in the placebo group (overall range 22-33). Approximately 90% of patients in each group completed the study.
The study showed that at the end of treatment on day 15, the Hamilton Depression Rating Scale (HAM-D) score for patients receiving SAGE-217 was statistically significantly lower (p < 0.0001) 17.6 points, compared with an average of 10.7 points for placebo. (p<0.0001). Most patients (64%) receiving SAGE-217 achieved a HAM-D total score of less than or equal to 7 on day 15 (placebo: 23%, p = 0.0005). Other secondary endpoints (eg, MADRS, CGI-I) were also highly significant at day 15 (p < 0.002).
The HAM-D total score was statistically significantly lower relative to baseline, observed on day 2 after the first dose and maintained until week 4 after treatment (p < 0.0318). At week 4, the HAM-D total score for the SAGE-217 group decreased by an average of 15.6, and the placebo group decreased by 11.9 (p = 0.0243). Remission rates at weeks 4 and 6 were 52% and 45%, respectively, in patients receiving SAGE-217, compared with 28% and 33% in the placebo group, and statistically significant (p = 0.0221) to 4 week.
â–² Dr. Jeff Jonas, CEO of Sage Therapeutics (Source: Sage Official Website)
“These encouraging data show the potential of SAGE-217 in the treatment of MDD and other mood-related diseases,†said Dr. Jeff Jonas, CEO of Sage Therapeutics: “There have been few discoveries and developments in the treatment of depression over the past two decades. What's new. Together with our recent phase 3 clinical data on brexanolone's treatment of postpartum depression, the findings of this study suggest that our proprietary GABA A modulator pipeline may affect basic brain mechanisms and provide potential development for a variety of indications. Opportunity. The positive activity and safety of SAGE-217 in MDD supports the advancement of the drug to the later stages of clinical development, and we will work with the FDA to determine the next step in SAGE-217.
“There is a significant gap in the management of disease in depression. Sage's development goal is to change the expectations of patients by changing the MDD treatment plan.†Dr. Steve Kanes, Chief Medical Officer of Sage Therapeutics, said: “If successful, SAGE-217 is possible. Became the first drug in more than 20 years to provide a truly new mechanism of action for the treatment of depression. If the results of this trial are confirmed in Phase 3 clinical trials, SAGE-217 can meet the daily oral needs of MDD patients. This treatment has the potential to provide rapid, well tolerated and long lasting height relief."
SAGE-217 was awarded the FDA-approved fast track qualification in May 2017. We expect this drug to successfully enter Phase 3 clinical trials, confirm the results of Phase 2 clinical trials, and bring the first innovative drug in 20 years to patients with major depression.
Reference materials:
[1] Sage Therapeutics Erupts as Depression Drug Wows in Mid-Stage Study
[2] Sage Therapeutics Reports Positive Top-line Results from Phase 2 Placebo-Controlled Trial of SAGE-217 in Major Depressive Disorder
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