SciSparc Awaiting Approval For Phase IIb Study Of Its Dronabinol Based Drug For Treatment Of Tourette Syndrome
SciSparc Awaiting Approval For Phase IIb Study Of Its Dronabinol Based Drug For Treatment Of Tourette Syndrome
SciSparc Ltd. (NASDAQ:SPRC), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, has successfully completed the development of its top-tier drug candidate SCI-110 to be used in its upcoming multinational, multi-center, Phase IIb study for Tourette syndrome ("TS").
SciSparc Ltd.納斯達克(Sequoia Capital：SPRC)，一家專注於開發治療中樞神經系統疾病的療法的專業臨牀階段製藥公司，已經成功地完成了其頂級候選藥物SCI-110的開發將用於其即將進行的多國、多中心、抽動症(TS)的IIb期研究。
The company received ethics committee approvals from Hannover Medical School in Hannover, Germany, and the Tel Aviv Sourasky Medical Center, in Tel Aviv, Israel. SCI-110 is developed and manufactured by Procaps Group S.A., a leader in contract development and manufacturing services in soft-gel advanced technologies for the global pharmaceutical industry.
該公司獲得了德國漢諾威的漢諾威醫學院和以色列特拉維夫的特拉維夫Sourasky醫療中心的倫理委員會的批准。SCI-110是由Procaps Group S.A.開發和製造.，全球製藥行業軟凝膠先進技術合同開發和製造服務的領先者。
"Completing the development of our unique drug candidate SCI-110 for the upcoming Phase IIb trial is another significant milestone for the company, making SciSparc well positioned to introduce an impactful treatment for TS patients that have very limited treatment options today," stated Oz Adler, SciSparc's CEO. "Our singular objective in developing SCI-110 is to develop a safe and effective treatment for this devastating, unmet medical need as soon as possible; and this milestone brings us one step closer."
完成我們獨特的候選藥物SCI-110的開發即將進行的第二階段試驗這是該公司的又一個重要里程碑，使SciSparc能夠很好地為目前治療選擇非常有限的TS患者推出一種有效的治療方法奧茲·阿德勒，SciSparc首席執行官。我們開發SCI-110的唯一目標是儘快為這種毀滅性的、未得到滿足的醫療需求開發一種安全有效的治療方法；這一里程碑使我們更近了一步。
TS is a movement and neurobehavioral disorder characterized by chronic motor and vocal tics. With onset before age 18, about half to two-thirds of TS cases improve during adolescence, while adults are generally more severe patients. Tics may be associated with a premonitory sensation to perform a specific action, which may lead to "relief" once performed.
TS是一種以慢性運動和聲帶痙攣為特徵的運動和神經行為障礙。在18歲之前發病，大約一半到三分之二的TS病例在青春期得到改善，而成年人通常是更嚴重的患者。抽搐可能與先兆感覺有關，以執行特定的動作，一旦執行，可能會導致“緩解”。
The objective of this Phase IIb randomized, multi-national, multi-center, double-blind, placebo controlled cross-over study is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adult patients (between 18 and 65 years of age) using oral treatment daily. The patients will be randomized in a 1:1 ratio to receive either SCI-110 or a SCI-110 matched placebo. The primary efficacy objective of the study will be to assess tic severity change using Yale global tic severity scale (YGTSS-R-TTS), the most commonly used measure in clinical trials, as a continuous endpoint at week 12 and week 26 of the double-blind phase compared to baseline. The primary safety objective of the study will be to assess absolute and relative frequencies of serious adverse events for the entire population and separately for the SCI-110 and placebo groups.
這項IIb期隨機、多國家、多中心、雙盲、安慰劑對照交叉試驗的目的是評估每日口服治療的成人患者(年齡在18歲至65歲之間)的SCSparc專利候選藥物SCI-110的有效性、安全性和耐受性。這些患者將按1：1的比例隨機接受SCI-110或SCI-110匹配的安慰劑。這項研究的主要療效目標將是使用耶魯全球抽動嚴重程度量表(YGTSS-R-TTS)來評估抽動嚴重程度的變化，YGTSS-R-TTS是臨牀試驗中最常用的衡量標準，作為與基線相比，在雙盲階段的第12周和第26周的連續終點。這項研究的主要安全目標將是評估所有人羣以及SCI-110組和安慰劑組嚴重不良事件的絕對和相對頻率。
The launch of the trial is pending approvals by the Ministry of Health in both Germany and Israel.
這個試驗的啟動正在等待批准由德國和以色列的衞生部提供。
譯文內容由第三人軟體翻譯。