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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:外國發行人報告
美股SEC公告 ·  2024/09/23 21:13

牛牛AI助理已提取核心訊息

SciSparc has received FDA approval to proceed with Phase IIb clinical trials for its first-in-class drug candidate SCI-110 in adult patients with Tourette Syndrome. The approval came within a month of the application submission on August 23, 2024. The trial will be conducted at three leading centers: Yale School of Medicine, Hannover Medical School, and Tel Aviv Sourasky Medical Center.The Phase IIb trial will evaluate the efficacy, safety, and tolerability of SCI-110 in adults aged 18-65 years through daily oral treatment. Patients will be randomized 1:1 to receive either SCI-110 or placebo. The primary efficacy endpoint will measure tic severity changes using the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline.The company has already secured Institutional Review Board approvals from all three clinical sites and related federal administrations. This milestone reinforces SciSparc's ambition to become a leading provider of treatments for central nervous system disorders, building on the excellent results from their previous Phase IIa clinical trial.
SciSparc has received FDA approval to proceed with Phase IIb clinical trials for its first-in-class drug candidate SCI-110 in adult patients with Tourette Syndrome. The approval came within a month of the application submission on August 23, 2024. The trial will be conducted at three leading centers: Yale School of Medicine, Hannover Medical School, and Tel Aviv Sourasky Medical Center.The Phase IIb trial will evaluate the efficacy, safety, and tolerability of SCI-110 in adults aged 18-65 years through daily oral treatment. Patients will be randomized 1:1 to receive either SCI-110 or placebo. The primary efficacy endpoint will measure tic severity changes using the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline.The company has already secured Institutional Review Board approvals from all three clinical sites and related federal administrations. This milestone reinforces SciSparc's ambition to become a leading provider of treatments for central nervous system disorders, building on the excellent results from their previous Phase IIa clinical trial.
SciSparc已獲得FDA批准,針對其首個一類藥物候選SCI-110在成年圖雷特綜合症患者中進行IIb期臨牀試驗。該批准是在2024年8月23日提交申請後一個月內獲得的。試驗將在三個頂尖中心進行:耶魯醫學院、漢諾威醫科大學和特拉維夫索拉斯基醫療中心。IIb期試驗將通過每日口服治療評估SCI-110在18至65歲成年患者中的療效、安全性和耐受性。患者將以1:1隨機分配接受SCI-110或安慰劑。主要療效終點將比較第12周和第26周的抽動嚴重程度變化,使用耶魯全球抽動嚴重程度量表與基線進行比較。該公司已經從所有三個臨牀中心及相關聯邦管理機構獲得了機構審查板的批准。這一里程碑強化了SciSparc成爲中樞神經系統疾病治療領導者的雄心,基於其之前IIa期臨牀試驗的優秀結果。
SciSparc已獲得FDA批准,針對其首個一類藥物候選SCI-110在成年圖雷特綜合症患者中進行IIb期臨牀試驗。該批准是在2024年8月23日提交申請後一個月內獲得的。試驗將在三個頂尖中心進行:耶魯醫學院、漢諾威醫科大學和特拉維夫索拉斯基醫療中心。IIb期試驗將通過每日口服治療評估SCI-110在18至65歲成年患者中的療效、安全性和耐受性。患者將以1:1隨機分配接受SCI-110或安慰劑。主要療效終點將比較第12周和第26周的抽動嚴重程度變化,使用耶魯全球抽動嚴重程度量表與基線進行比較。該公司已經從所有三個臨牀中心及相關聯邦管理機構獲得了機構審查板的批准。這一里程碑強化了SciSparc成爲中樞神經系統疾病治療領導者的雄心,基於其之前IIa期臨牀試驗的優秀結果。

譯文內容由第三人軟體翻譯。


牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生。


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