Pharma Company Gets FDA Green Light For Next Phase Trial For Tourette Syndrome
Pharma Company Gets FDA Green Light For Next Phase Trial For Tourette Syndrome
SciSparc's drug candidate, SCI-110,SciSparc Ltd.(NASDAQ:SPRC), a clinical-stage pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved its investigational new drug (IND), which enables the company to proceed to Phase IIb clinical trial for its medication to treat Tourette Syndrome (TS).
納斯達克上市的SciSparc Ltd.（SPRC）是一家處於臨床階段的藥品公司，宣佈美國食品藥品監督管理局（FDA）已批准其新藥物研究（IND），使該公司可以進入第IIb期臨床試驗階段，用於治療抽動症（TS）的藥物。
This FDA approval is a significant milestone for the company as it seeks to address unmet medical needs in managing TS.
這次FDA的批准對該公司來說是一個重要的里程碑，因爲該公司正在尋求解決管理TS中存在的未滿足的醫療需求。
SciSparc Targets Unmet Medical
SciSparc目標未滿足的醫療需求
Tourette Syndrome is a complex neurological disorder that affects patients worldwide, especially children and adolescents. Existing treatments often fall short of effectively managing symptoms. "As the currently used medications are managing only a small number of disease symptoms with limited efficacy and questionable safety, we believe there is a clear unmet medical need for the management of TS," said SciSparc's CEO, Oz Adler.
抽動症是一種影響全球患者，特別是兒童和青少年的複雜神經系統紊亂。現有的治療方法通常無法有效地管理症狀。 「由於目前使用的藥物僅管理了少數疾病症狀，其功效有限且安全性存疑，我們認爲管理TS存在明顯的未滿足的醫療需求，」SciSparc的首席執行官Oz Adler表示。
SciSparc's drug candidate, SCI-110, has already shown promising results in earlier trials. A Phase IIa clinical trial at Yale University demonstrated a reduction in TS-related tics of 21% across patients with almost 40% of participants experiencing a greater than 25% reduction.
SciSparc的藥物候選品SCI-110已在早期試驗中表現出有希望的結果。在耶魯大學進行的IIa期臨床試驗顯示，患者的TS相關抽動減少了21％，近40％的參與者經歷了大於25％的減少。
Read Also: CBD & THC Combined Helps Treat Tourette Syndrome Symptoms, New Study Finds
閱讀更多：CBD和THC的聯合有助於治療抽動症症狀，新研究發現
Global Clinical Trial To Start Soon
全球臨床試驗即將開始
The upcoming Phase IIb trial will take place at three medical institutions: the Yale Child Study Center in Connecticut, the Hannover Medical School in Germany and the Tel Aviv Sourasky Medical Center in Israel.
即將進行的第IIb期試驗將在三家醫療機構進行：康涅狄克州耶魯兒童研究中心，德國漢諾威醫學院和以色列特拉維夫索拉斯基醫療中心。
This trial will focus on assessing the efficacy, safety, and tolerability in adult patients. "The therapy of choice should also have a favorable safety profile, allowing for high patient drug compliance," Adler added.
該試驗將重點評估成人患者的療效、安全性和耐受性。"治療選擇還應具有良好的安全性概況，以確保患者高度遵從藥物治療，" Adler 表示。
Participants in the trial will be randomized at a 1:1 ratio to receive either SCI-110 or a placebo. The trial will measure changes using the Yale Global Tic Severity Scale at weeks 12 and 26, with the primary safety objective being to assess serious adverse events across the patient population.
試驗中的參與者將以 1:1 的比例隨機分配，分別接受 SCI-110 或安慰劑。該試驗將在第 12周和第 26周使用耶魯全球抽動嚴重度量表進行變化測量，主要安全目標是評估整個患者群中的嚴重不良事件。
Cannabinoids And The Broader Vision
大麻類化合物和更廣泛的願景
SciSparc is specialized in cannabinoid-based treatments for neurological disorders.
SciSparc 在神經系統疾病的大麻類化合物治療方面專業化。
Besides SCI-110 for TS, the company is also exploring its potential for Alzheimer's disease and agitation. "We believe our innovative drug candidate SCI-110 has the potential to be this desired therapy," Adler said.
除了用於TS的 SCI-110 外，公司還在探索其在阿爾茨海默病和煩躁症中的潛力。"我們相信我們的創新藥物候選 SCI-110 有可能成爲這種期望的治療方法，" Adler 說。
- Read Also: Cannabis For Tourette Syndrome? Significant Improvement In Quality Of Life, Finds Israeli Study
- 讀文章: 特發性抽動症的大麻？以色列研究發現生活質量顯著提高
Cover: AI generated image
封面: 人工智能生成的圖像
譯文內容由第三人軟體翻譯。