SciSparc Takes Major Step Forward With IND Application Submitted to the FDA for Phase IIb Clinical Trial for Tourette Syndrome Treatment
SciSparc Takes Major Step Forward With IND Application Submitted to the FDA for Phase IIb Clinical Trial for Tourette Syndrome Treatment
The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adult patients (between the ages of 18 and 65 years) using a daily oral treatment. The patients will be randomized at a 1:1 ratio to receive either SCI-110 or a SCI-110-matched placebo. The primary efficacy objective of the trial will be to assess tic severity change using the Yale Global Tic Severity Scale, the most commonly used measure in clinical trials of this kind, as a continuous endpoint at weeks 12 and 26 of the double-blind phase compared to baseline. The primary safety objective of the trial is to assess absolute and relative frequencies of serious adverse events for the entire population and, separately, for the SCI-110 and placebo groups.Yale Child Study Center at the Yale School of Medicine in the USA, Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel will take part in the trial
美國的耶魯醫學院耶魯兒童研究中心、德國的漢諾威醫學院和以色列的特拉維夫索拉斯基醫療中心將參加這項試驗
TEL AVIV, Israel, Sept. 18, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, has taken a major step forward with its proprietary SCI-110 for the treatment of Tourette Syndrome ("TS"), with its submission of an Investigational New Drug application to the U.S. Food and Drug Administration for its phase IIb clinical trial, as previously announced on August 23, 2024.
以色列特拉維夫，2024年9月18日(GLOBE NEWSWIRE) -- SciSparc Ltd. (納斯達克:SPRC) ("公司"或"SciSparc")，一家專業的臨床階段藥品公司，專注於開發治療中樞神經系統疾病和罕見病的療法，近日通過其SCI-110藥物爲治療特瑞特綜合徵("TS")邁出重要一步，已提交了一份用於其IIb期臨床試驗的新藥申請給美國食品與藥物管理局，該消息早前於2024年8月23日宣佈。
The phase IIb clinical trial will be conducted at three global leading centers of excellence: the Yale Child Study Center at the Yale School of Medicine in Connecticut, United States, the Hannover Medical School in Hannover, Germany, and at the Tel Aviv Sourasky Medical Center in Israel ("Sourasky"). The Company has already secured the Institutional Review Board approvals from all three clinical sites, the Israeli Ministry of Health's approval for the clinical trial at Sourasky, and approval from the Federal Institute for Drugs and Medical Devices in Germany for conducting the trial at the Hannover Medical School.
IIb期臨床試驗將在三個全球領先的卓越中心進行: 美國康涅狄克州的耶魯醫學院耶魯兒童研究中心、德國漢諾威醫學院和以色列特拉維夫索拉斯基醫療中心("索拉斯基")。該公司已經獲得了三個臨床地點的倫理審查委員會批准、以色列衛生部對索拉斯基臨床試驗的批准，以及德國聯邦藥品和醫療器械監管局對在漢諾威醫學院進行試驗的批准。
The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adult patients (between the ages of 18 and 65 years) using a daily oral treatment. The patients will be randomized at a 1:1 ratio to receive either SCI-110 or a SCI-110-matched placebo. The primary efficacy objective of the trial will be to assess tic severity change using the Yale Global Tic Severity Scale, the most commonly used measure in clinical trials of this kind, as a continuous endpoint at weeks 12 and 26 of the double-blind phase compared to baseline. The primary safety objective of the trial is to assess absolute and relative frequencies of serious adverse events for the entire population and, separately, for the SCI-110 and placebo groups.
這項臨床試驗的目標是評估SciSparc的SCI-110藥物候選在成年患者(18至65歲之間)中使用每日口服治療的療效、安全性和耐受性。患者將以1:1的比例隨機分配，接受SCI-110或SCI-110配對安慰劑。試驗的主要療效目標將是通過在雙盲階段的第12周和第26周相對於基線使用耶魯全球抽動嚴重性量表評估抽動嚴重度的變化，該量表是這類臨床試驗中最常用的度量工具。試驗的主要安全性目標是評估整體人群的嚴重不良事件的絕對和相對頻率，以及SCI-110組和安慰劑組分別的嚴重不良事件頻率。
About SciSparc Ltd. (Nasdaq: SPRC):
關於SciSparc有限公司（納斯達克：SPRC）：
SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc's focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive CBD: SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer's disease and agitation; and SCI-210 for the treatment of ASD and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seeds oil-based products on Amazon Marketplace.
SciSparc Ltd.是一家專注於臨床階段的藥品公司，由一支經驗豐富的高級執行官和科學家團隊領導。SciSparc專注於基於大麻藥品的創造和增強技術和資產組合。在這個重點領域，公司目前正在進行基於THC和/或無精神活性CBD的以下藥物開發項目：SCI-110用於治療多動症和阿爾茨海默病的治療以及煩躁行爲；以及 SCI-210用於治療自閉症障礙和癲癇持續狀態。該公司還持有一個子公司的控股權，其業務重點是在亞馬遜市場銷售基於大麻籽油的產品。
Forward-Looking Statements:
前瞻性聲明：
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses the format, structure and objective of the clinical trials for the phase IIb clinical trial. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Because such statements deal with future events and are based on SciSparc's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SciSparc's Annual Report on Form 20-F filed with the SEC on April 1, 2024, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.
本新聞稿包含根據1995年《私人證券訴訟改革法案》和其他聯邦證券法中"安全港"規定的前瞻性聲明。例如，SciSparc在討論第IIb期臨床試驗的格式，結構和目標時，正在使用前瞻性聲明。科學研究和臨床預試驗的歷史結果並不保證未來研究或試驗的結論將提出相同甚至類似的結論。由於這些聲明涉及未來事件並基於SciSparc當前的期望，因此它們受到各種風險和不確定性的影響，SciSparc的實際結果、表現或成就可能與本新聞稿中的聲明描述或暗示的內容有實質性差異。本新聞稿中包含或暗示的前瞻性聲明還受其他風險和不確定性的影響，包括SciSparc於2024年4月1日與美國證券交易委員會（SEC）提交的20-F表中討論的風險因素，並在隨後提交給美國證券交易委員會的文件中討論的風險因素。除非法律另有要求，否則SciSparc不承擔任何更新或修改前瞻性聲明的意向或義務，這些聲明僅在其發佈之日起生效，不管是因爲信息更新、未來事件或情況變化還是其他原因。
Investor Contact:
IR@scisparc.com
Tel: +972 3-761-7108
投資者聯繫人：
IR@scisparc.com
Tel: +972 3-761-7108
譯文內容由第三人軟體翻譯。
