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Sage Therapeutics TM Sage Therapeutics and Biogen Announce SAGE - 324 Phase 2 Placebo - Controlled KINETIC Study in Essential Tremor Met Primary Endpoint April 12 , 2021 Statistically significant reduction in tremor score compared to placebo at Day 29 in adults with essential tremor SAGE - 324 demonstrated a 36 % reduction in upper limb tremor amplitude from baseline at Day 29 in the total studied population ; in a more severe population ( baseline TETRAS Upper Limb Item 4 > 12 ) , SAGE - 324 demonstrated a 41 % reduction in upper limb tremor amplitude compared to baseline SAGE - 324 demonstrated a safety profile generally consistent with previously reported data Sage Therapeutics to host conference call today at 8 a.m. ET CAMBRIDGE , Mass .-- ( BUSINESS WIRE ) -- Apr . 12 , 2021-- Sage Therapeutics , Inc. ( Nasdaq : SAGE ) and Biogen Inc. ( Nasdaq : BIIB ) today reported topline results from the Phase 2 KINETIC Study evaluating SAGE - 324 in the treatment of people with essential tremor ( ET ) . The study ( n = 67 full analysis set ) achieved its primary endpoint of a statistically significant reduction from baseline compared to placebo in The Essential Tremor Rating Assessment Scale ( TETRAS ) Performance Subscale Item 4 upper limb tremor score on Day 29 ( P = 0.049 ) , which corresponded to a 36 % reduction from baseline in upper limb tremor amplitude in patients receiving SAGE - 324 compared to a 21 % reduction in patients receiving placebo . Activities of daily living ( ADL ) scores showed a statistically significant correlation with upper limb tremor score at all timepoints . While not powered to fully examine TETRAS ADL , SAGE - 324 was numerically superior to placebo at all time points . Reported treatment - emergent adverse events ( TEAEs ) were generally consistent with the safety profile of SAGE - 324 to date . This press release features multimedia . View the full release here : https://www.businesswire.com/news/home/20210412005277/en/ In the KINETIC Study , patients ( n = 47 ) with a more severe tremor at baseline ( at or above the median TETRAS Performance Subscale upper limb tremor Item 4 score of 12 ) who received SAGE - 324 , demonstrated a statistically significant reduction ( P = 0.007 ) from baseline in TETRAS Performance Subscale Item 4 upper limb tremor score compared to placebo at Day 29 , corresponding to a 41 % reduction from baseline in upper limb tremor amplitude in patients receiving SAGE - 324 compared to an 18 % reduction for placebo . Study patients were not taking other medications for ET during the 28 - day treatment period . The collaboration partners are pleased with the progress to date and are planning next steps for development of SAGE - 324 . " In the design of the KINETIC Study , we set a high bar and believe we exceeded it . SAGE - 324 met the primary endpoint in the trial and demonstrated a safety profile generally consistent with previously reported data . The strong correlation observed in this study between TETRAS performance scale - measuring reduction of upper limb tremor , a disabling symptom experienced by more than 90 % of people suffering from essential tremor -- and improvement on the ADL score provides suggestive evidence that these findings have the potential to be truly impactful for people with essential tremor , " said Barry Greene , chief executive officer at Sage Therapeutics . " We believe the data announced today provide clear support and insights for the continued development of SAGE - 324 in an area of significant unmet medical need . People with brain health disorders have been conditioned to accept the status quo due to limited innovation or the lack of truly transformative medicines in recent years - and that's certainly been the case with essential tremor . However , at Sage , we believe that people suffering from brain health disorders deserve better and we aim to help achieve that . " " We are encouraged by the positive results of the KINETIC Study , which indicate that SAGE - 324 may provide relief in people suffering with essential tremor , a movement disorder that affects an estimated 6.4 million people - and is one of the most common movement disorders – in the United States , " said Alfred Sandrock , Jr. , M.D. , Ph.D. , Head of Research and Development at Biogen . " For people with essential tremor , uncontrollable shaking of the hands , head , voice , or legs can create difficulty eating , dressing , writing , and pursuing other day - to - day tasks . It is our hope that , in collaboration with Sage , we will be able to deliver an innovative and meaningful new treatment option for these patients . The positive results of the KINETIC Study represent one step further towards that goal , and also underscore Biogen's commitment to delivering new therapeutic options to patients living with movement disorders that have high medical unmet need , including essential tremor . ” " There is an extraordinary unmet need for people suffering with essential tremor , a condition that can cause significant disability in patients , " said Dr. Rodger Elble , M.D. , a neurologist at the Southern Illinois University School of Medicine . " The only approved medicine was developed more than 50 years ago , and most medicines used for ET were developed for other conditions , and their benefits to people with ET were only discovered serendipitously . Current investigational drugs like SAGE - 324 , if successful , may offer potential for new treatment options for tremor management , as more than 50 % of people with ET do not respond optimally to the current standard of care . " Full data from the KINETIC Study will be shared at future scientific forums and in publications . Summary of Topline Results from KINETIC Study In the KINETIC Study , SAGE - 324 taken orally , once daily in the morning , showed a statistically significant reduction from baseline in upper limb tremor score as measured by Item 4 of TETRAS Performance Subscale on Day 29 compared to placebo . TETRAS Scale includes two subscales : the Performance Subscale and the Activities of Daily Living ( ADL ) Subscale . The TETRAS Performance Subscale is a validated , physician - administered scale designed to provide an accurate , comprehensive assessment of ET motor symptoms and has been shown to correlate with TETRAS ADL . The