SciSparc Receives FDA Approval to Initiate Phase IIb Clinical Trial for Tourette Syndrome Treatment
SciSparc (Nasdaq: SPRC) has received FDA approval to proceed with its Phase IIb clinical trial for SCI-110, a potential Tourette Syndrome treatment. The trial will be conducted at three leading centers: Yale School of Medicine, Hannover Medical School, and Tel Aviv Sourasky Medical Center. The study aims to evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients aged 18-65 years.
The randomized, placebo-controlled trial will assess tic severity changes using the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline. SciSparc 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.
SciSparc (Nasdaq: SPRC) ha ricevuto l'approvazione della FDA per procedere con il suo studio clinico di Fase IIb per SCI-110, un potenziale trattamento per la syndrome di Tourette. Il trial sarà condotto in tre centri di eccellenza: la Scuola di Medicina di Yale, la Scuola Medica di Hannover e il Centro Medico Sourasky di Tel Aviv. Lo studio mira a valutare l'efficacia, la sicurezza e la tollerabilità di SCI-110 in pazienti adulti di età compresa tra 18 e 65 anni.
Il trial randomizzato, controllato con placebo, valuterà le variazioni della gravità dei tic utilizzando la Yale Global Tic Severity Scale alle settimane 12 e 26 rispetto al basale. SciSparc ha già ottenuto le approvazioni del Comitato Etico da tutti e tre i siti clinici e dalle relative amministrazioni federali. Questo traguardo rafforza l'ambizione di SciSparc di diventare un fornitore leader di trattamenti per i disturbi del sistema nervoso centrale.
SciSparc (Nasdaq: SPRC) ha recibido la aprobación de la FDA para proceder con su ensayo clínico de Fase IIb para SCI-110, un tratamiento potencial para el Síndrome de Tourette. El ensayo se llevará a cabo en tres centros de referencia: la Escuela de Medicina de Yale, la Escuela de Medicina de Hannover y el Centro Médico Sourasky de Tel Aviv. El estudio tiene como objetivo evaluar la eficacia, seguridad y tolerancia de SCI-110 en pacientes adultos de entre 18 y 65 años.
El ensayo aleatorio controlado con placebo evaluará los cambios en la gravedad de los tics utilizando la Escala de Gravedad Global de Tics de Yale en las semanas 12 y 26 en comparación con la línea base. SciSparc ya ha asegurado las aprobaciones de la Junta de Revisión Institucional de los tres sitios clínicos y de las administraciones federales relacionadas. Este hito refuerza la ambición de SciSparc de convertirse en un proveedor líder de tratamientos para los trastornos del sistema nervioso central.
SciSparc (Nasdaq: SPRC)는 SCI-110의 2b상 임상시험을 진행하기 위한 FDA 승인을 받았습니다. 이는 투렛 증후군의 잠재적 치료제입니다. 이 시험은 예일 의과대학, 하노버 의학대학, 텔아비브 소라스키 의료센터의 세 곳에서 실시됩니다. 이 연구는 18세에서 65세 사이의 성인 환자에서 SCI-110의 효능, 안전성 및 내약성을 평가하는 것을 목표로 합니다.
무작위 이중 맹검 실시될 이 시험에서는 12주와 26주 차에 Yale Tic Severity Scale을 통해 틱의 중증도 변화를 baseline과 비교하여 평가합니다. SciSparc는 이미 세 곳의 임상 기관과 관련 연방 행정 기관으로부터 제도적 윤리위원회의 승인을 확보했습니다. 이 이정표는 SciSparc가 중앙 신경계 장애 치료의 주요 공급자가 되고자 하는 야망을 강화합니다.
SciSparc (Nasdaq: SPRC) a reçu l'approbation de la FDA pour procéder à son essai clinique de phase IIb pour le SCI-110, un traitement potentiel pour le syndrome de Tourette. L'essai sera mené dans trois centres de renommée : l'École de Médecine de Yale, l'École de Médecine de Hanovre et le Centre Médical Sourasky de Tel Aviv. L'étude vise à évaluer l'efficacité, la sécurité et la tolérance du SCI-110 chez des patients adultes âgés de 18 à 65 ans.
L'essai randomisé contrôlé par placebo évaluera les variations de la gravité des tics à l'aide de l'Échelle de Sévérité Globale des Tics de Yale aux semaines 12 et 26 par rapport à la ligne de base. SciSparc a déjà obtenu les approbations des comités d'éthique des trois sites cliniques et des administrations fédérales concernées. Ce jalon renforce l'ambition de SciSparc de devenir un fournisseur de premier plan de traitements pour les troubles du système nerveux central.
SciSparc (Nasdaq: SPRC) hat die Genehmigung der FDA erhalten, um mit seiner Phase-IIb-Studie für SCI-110 fortzufahren, einer potenziellen Behandlung für Tourette-Syndrom. Die Studie wird an drei führenden Zentren durchgeführt: der Yale School of Medicine, der Medizinischen Hochschule Hannover und dem Tel Aviv Sourasky Medical Center. Ziel der Studie ist es, die Wirksamkeit, Sicherheit und Verträglichkeit von SCI-110 bei erwachsenen Patienten im Alter von 18 bis 65 Jahren zu evaluieren.
Die randomisierte, placebokontrollierte Studie wird die Veränderungen der Tic-Schweregrade unter Verwendung der Yale Global Tic Severity Scale in den Wochen 12 und 26 im Vergleich zur Ausgangsbasis bewerten. SciSparc hat bereits die Genehmigungen der Ethikkommission von allen drei klinischen Standorten sowie von den entsprechenden Bundesbehörden erhalten. Dieser Meilenstein verstärkt SciSparcs Ambition, ein führender Anbieter von Behandlungen für Störungen des zentralen Nervensystems zu werden.
- FDA approval received for Phase IIb clinical trial of SCI-110
- Trial to be conducted at three globally recognized medical centers
- Institutional Review Board approvals secured from all clinical sites
- Previous Phase IIa clinical trial showed excellent results
- None.
FDA confirms that SciSparc’s study may proceed following the application submission a month ago
TEL AVIV, Israel, Sept. 23, 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, today announced that the U.S. Food and Drug Administration (“FDA”) has confirmed that its investigational new drug (“IND”) application for its first in class drug candidate SCI-110 study may proceed with its Phase IIb clinical trials in the U.S. in adults patients with Tourette Syndrome (“TS”).
SciSparc has taken a major step forward with its proprietary SCI-110 for the treatment of Tourette Syndrome (“TS”) with its submission of an IND application to the FDA for its phase IIb clinical trial, as previously announced on August 23, 2024.
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. The Company has already secured the Institutional Review Board approvals from all three clinical sites, as well as approval from all related federal administrations.
Oz Adler, Chief Executive Officer of SciSparc, said “We are very excited to reach this milestone with our first-in-class platform SCI-110 which reinforces our ambition to become a leading company to provide safe and effective treatments to patients with central nervous system disorders. The application was swiftly approved by the FDA within a month after its submission, together with the excellent results we received using this platform in the previous Phase IIa clinical trial, reinforces our belief in our ability to offer a novel safe and effective treatment for Tourette’s patients.”
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.
About SciSparc Ltd. (Nasdaq: 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 TS, 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.
Forward-Looking Statements:
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 Company’s ambition to become a leading company to provide safe and effective treatments to patients with central nervous system disorders; its belief in its ability to offer a novel safe and effective treatment for TS patients; and 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.
Investor Contact:
IR@scisparc.com
Tel: +972 3-761-7108
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