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SciSparc | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

SciSparc | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

SciSparc | 6-K:外国发行人报告
美股SEC公告 ·  2024/08/26 18:17

Moomoo AI 已提取核心信息

SciSparc Ltd. has submitted an Investigational New Drug (IND) application to the FDA for its Phase IIb clinical trial of SCI-110, targeting Tourette Syndrome treatment. The trial will be conducted at three prestigious institutions: Yale Child Study Center, Hannover Medical School, and Tel Aviv Sourasky Medical Center, with all necessary institutional approvals already secured.The trial will evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients aged 18-65 years through a randomized, placebo-controlled study. The primary efficacy endpoint will measure tic severity changes using the Yale Global Tic Severity Scale at weeks 12 and 26, while monitoring safety through assessment of adverse events.The company's proprietary drug candidate SCI-110, combining dronabinol and palmitoylethanolamide, represents a potential breakthrough in Tourette Syndrome treatment. The trial's commencement marks a significant milestone for SciSparc's development program, supported by leading researchers in the field.
SciSparc Ltd. has submitted an Investigational New Drug (IND) application to the FDA for its Phase IIb clinical trial of SCI-110, targeting Tourette Syndrome treatment. The trial will be conducted at three prestigious institutions: Yale Child Study Center, Hannover Medical School, and Tel Aviv Sourasky Medical Center, with all necessary institutional approvals already secured.The trial will evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients aged 18-65 years through a randomized, placebo-controlled study. The primary efficacy endpoint will measure tic severity changes using the Yale Global Tic Severity Scale at weeks 12 and 26, while monitoring safety through assessment of adverse events.The company's proprietary drug candidate SCI-110, combining dronabinol and palmitoylethanolamide, represents a potential breakthrough in Tourette Syndrome treatment. The trial's commencement marks a significant milestone for SciSparc's development program, supported by leading researchers in the field.
SciSparc有限公司已向FDA提交了针对其SCI-110的二期临床试验的调查新药(IND)申请,旨在治疗妥瑞综合症。该试验将在三家著名的机构进行:耶鲁儿童研究中心、汉诺威医科大学和特拉维夫索拉斯基医疗中心,所有必要的机构批准均已获得。该试验将通过随机、安慰剂对照研究评估SCI-110在18至65岁成人患者中的疗效、安全性和耐受性。主要疗效终点将通过耶鲁全球抽动严重程度量表在第12周和第26周测量抽动严重性变化,同时通过不良事件评估监测安全性。该公司的专有药物候选物SCI-110结合了大麻二酚和棕榈酸乙醇酰胺,代表着妥瑞综合症治疗的一项潜在突破。试验的开始标志着SciSparc开发计划的一个重要里程碑,并得到了该领域领先研究人员的支持。
SciSparc有限公司已向FDA提交了针对其SCI-110的二期临床试验的调查新药(IND)申请,旨在治疗妥瑞综合症。该试验将在三家著名的机构进行:耶鲁儿童研究中心、汉诺威医科大学和特拉维夫索拉斯基医疗中心,所有必要的机构批准均已获得。该试验将通过随机、安慰剂对照研究评估SCI-110在18至65岁成人患者中的疗效、安全性和耐受性。主要疗效终点将通过耶鲁全球抽动严重程度量表在第12周和第26周测量抽动严重性变化,同时通过不良事件评估监测安全性。该公司的专有药物候选物SCI-110结合了大麻二酚和棕榈酸乙醇酰胺,代表着妥瑞综合症治疗的一项潜在突破。试验的开始标志着SciSparc开发计划的一个重要里程碑,并得到了该领域领先研究人员的支持。
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