Intra-Cellular Stock Rallies On Successful Late-Stage Depression Treatment Study
Intra-Cellular Stock Rallies On Successful Late-Stage Depression Treatment Study
Intra-Cellular Therapies Inc (NASDAQ:ITCI) unveiled on Tuesday topline results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).
Topline results from the second Phase 3 study, Study 502, are anticipated late in the second quarter of this year.
Caplyta (lumateperone) is a once-daily pill proven to deliver significant symptom relief from bipolar I and bipolar II depression.
"We believe that these robust efficacy results coupled with its favorable safety and tolerability profile and convenient dosing make CAPLYTA a compelling option as an adjunctive treatment for MDD, if approved," said Sharon Mates, chairman and CEO of Intra-Cellular Therapies.
Lumateperone 42 mg, given once daily as adjunctive therapy to antidepressants, met the primary endpoint in Study 501 by demonstrating a statistically significant and clinically meaningful reduction in the MADRS total score compared to placebo at Week 6.
Montgomery–Åsberg Depression Rating Scale (MADRS) is a widely used clinician‐rated measure of depressive severity.
In the modified intent-to-treat (mITT) study population, the least squares (LS) mean reduction from baseline for lumateperone 42 mg was 14.7 points versus 9.8 points for placebo, with an effect size of 0.61.
Lumateperone 42 mg also met the key secondary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the CGI-S score (severity of illness), compared to placebo at Week 6, with an effect size of 0.67.
Statistically significant efficacy was seen at the earliest time point tested (Week 1) and maintained throughout the study in the primary and the key secondary endpoints.
In this study, lumateperone 42 mg robustly improved depressive symptoms, as reported by patients.
Lumateperone was generally safe and well-tolerated in this study.
ITCI Price Action: Intra-Cellular Therapies shares are up 27.60% at $82.64 at publication Tuesday.
Photo by Julia Koblitz via Unsplash
Intra-Cellular Therapies Inc (NASDAQ:ITCI) unveiled on Tuesday topline results from Study 501 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD).
細胞內療法公司（納斯達克股票代碼：ITCI）週二公佈了501號研究的主要結果，該研究評估了42毫克盧馬培隆作爲抗抑鬱藥的輔助療法，用於治療重度抑鬱症（MDD）。
Topline results from the second Phase 3 study, Study 502, are anticipated late in the second quarter of this year.
第二項第三階段研究（502號研究）的主要結果預計將在今年第二季度末公佈。
Caplyta (lumateperone) is a once-daily pill proven to deliver significant symptom relief from bipolar I and bipolar II depression.
Caplyta（lumateperone）是一種每日一次的藥丸，經證實可顯著緩解I型和II型雙相抑鬱症的症狀。
"We believe that these robust efficacy results coupled with its favorable safety and tolerability profile and convenient dosing make CAPLYTA a compelling option as an adjunctive treatment for MDD, if approved," said Sharon Mates, chairman and CEO of Intra-Cellular Therapies.
細胞內療法董事長兼首席執行官Sharon Mates表示：“我們相信，這些強勁的療效結果，加上其良好的安全性和耐受性以及便捷的劑量，如果獲得批准，CAPLYTA將成爲MDD輔助治療的引人注目的選擇。”
Lumateperone 42 mg, given once daily as adjunctive therapy to antidepressants, met the primary endpoint in Study 501 by demonstrating a statistically significant and clinically meaningful reduction in the MADRS total score compared to placebo at Week 6.
Lumateperone 42 mg，作爲抗抑鬱藥的輔助療法，在第 501 項研究中顯示，與安慰劑相比，第 6 周的 MADRS 總分在統計學上顯著且具有臨床意義的降低，達到了研究501的主要終點。
Montgomery–Åsberg Depression Rating Scale (MADRS) is a widely used clinician‐rated measure of depressive severity.
蒙哥馬利—阿斯伯格抑鬱評級量表（MADRS）是一種廣泛使用的臨床醫生評級抑鬱嚴重程度的衡量標準。
In the modified intent-to-treat (mITT) study population, the least squares (LS) mean reduction from baseline for lumateperone 42 mg was 14.7 points versus 9.8 points for placebo, with an effect size of 0.61.
在修改後的意向治療（MitT）研究人群中，lumateperone 42 mg的最小二乘（LS）平均值比基線下降14.7點，而安慰劑爲9.8個百分點，效應大小爲0.61。
Lumateperone 42 mg also met the key secondary endpoint in the study by demonstrating a statistically significant and clinically meaningful reduction in the CGI-S score (severity of illness), compared to placebo at Week 6, with an effect size of 0.67.
Lumateperone 42 mg也達到了該研究的關鍵次要終點，它表明，與第6周的安慰劑相比，CGI-S評分（疾病嚴重程度）具有統計學意義且具有臨床意義的降低，效應大小爲0.67。
Statistically significant efficacy was seen at the earliest time point tested (Week 1) and maintained throughout the study in the primary and the key secondary endpoints.
在最早的測試時間點（第一週）發現了具有統計學意義的療效，並且在整個研究過程中，主要和關鍵次要終點的療效保持不變。
In this study, lumateperone 42 mg robustly improved depressive symptoms, as reported by patients.
據患者報告，在這項研究中，42 mg的lumateperone有力地改善了抑鬱症狀。
Lumateperone was generally safe and well-tolerated in this study.
在這項研究中，Lumateperone總體上是安全的，耐受性良好。
ITCI Price Action: Intra-Cellular Therapies shares are up 27.60% at $82.64 at publication Tuesday.
ITCI價格走勢：週二公佈的細胞內療法股價上漲27.60％，至82.64美元。
Photo by Julia Koblitz via Unsplash
照片由 Julia Koblitz 通過 Unsplash
譯文內容由第三人軟體翻譯。
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