SciSparc Takes Major Step Forward with IND Application submitted to the FDA for Phase IIb Clinical Trial for Tourette Syndrome Treatment
SciSparc (Nasdaq: SPRC) has submitted an Investigational New Drug application to the FDA for a phase IIb clinical trial of SCI-110, its proprietary treatment for Tourette Syndrome. The trial will be conducted at three leading centers: Yale Child Study Center, Hannover Medical School, and Tel Aviv Sourasky Medical Center. The company has already secured necessary approvals from institutional review boards and relevant health authorities.
The trial aims to evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients aged 18-65 years. Participants will be randomized to receive either SCI-110 or a placebo. The primary efficacy objective is to assess tic severity change using the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline. The safety objective focuses on monitoring adverse events in both treatment groups.
SciSparc (Nasdaq: SPRC) ha presentato un'applicazione per un Nuovo Farmaco Investigazionale all'FDA per un trial clinico di fase IIb di SCI-110, il suo trattamento proprietario per la Sindrome di Tourette. Il trial sarà condotto in tre centri di eccellenza: Yale Child Study Center, Hannover Medical School e Tel Aviv Sourasky Medical Center. L'azienda ha già ottenuto le necessarie approvazioni dai comitati etici e dalle autorità sanitarie competenti.
Il trial ha l'obiettivo di valutare l'efficacia, la sicurezza e la tollerabilità di SCI-110 in pazienti adulti di età compresa tra 18 e 65 anni. I partecipanti saranno randomizzati per ricevere SCI-110 o un placebo. L'obiettivo primario di efficacia è valutare il cambiamento nella gravità dei tic utilizzando la Yale Global Tic Severity Scale alle settimane 12 e 26 rispetto al valore iniziale. L'obiettivo di sicurezza si concentra sul monitoraggio degli eventi avversi in entrambi i gruppi trattati.
SciSparc (Nasdaq: SPRC) ha presentado una solicitud para un Nuevo Medicamento en Investigación a la FDA para un ensayo clínico de fase IIb de SCI-110, su tratamiento propietario para el Síndrome de Tourette. El ensayo se llevará a cabo en tres centros líderes: Yale Child Study Center, Hannover Medical School y Tel Aviv Sourasky Medical Center. La empresa ya ha asegurado las aprobaciones necesarias de los comités de revisión institucional y de las autoridades de salud correspondientes.
El ensayo tiene como objetivo evaluar la eficacia, la seguridad y la tolerabilidad de SCI-110 en pacientes adultos de 18 a 65 años. Los participantes serán asignados al azar para recibir SCI-110 o un placebo. El objetivo primario de eficacia es evaluar el cambio en la gravedad de los tics utilizando la Yale Global Tic Severity Scale en las semanas 12 y 26 en comparación con la línea base. El objetivo de seguridad se centra en el monitoreo de eventos adversos en ambos grupos de tratamiento.
SciSparc(나스닥: SPRC)는 FDA에 SCI-110의 2b상 임상시험을 위한 임상 신약 신청서를 제출하였습니다. SCI-110은 투렛 증후군에 대한 자사의 독점 치료제입니다. 이 시험은 예일 아동 연구 센터, 하노버 의대 및 텔아비브 소라스키 의대에서 진행될 예정입니다. 회사는 이미 기관 윤리 위원회와 관련 보건 당국으로부터 필요한 승인을 확보했습니다.
이 시험의 목표는 18세에서 65세 사이의 성인 환자에서 SCI-110의 효능, 안전성 및 내약성을 평가하는 것입니다. 참가자는 SCI-110 또는 플라시보를 받도록 무작위 배정됩니다. 주요 효능 목표는 12주 및 26주에 걸쳐 Yale Global Tic Severity Scale을 사용하여 틱의 중증도 변화를 평가하는 것입니다. 안전성 목표는 두 치료 그룹에서의 부작용 모니터링에 초점을 맞춥니다.
SciSparc (Nasdaq: SPRC) a soumis une demande d'Autorisation de Médicament de Nouvelle Recherche à la FDA pour un essai clinique de phase IIb de SCI-110, son traitement propriétaire pour le Syndrome de Tourette. L'essai sera mené dans trois centres d'excellence : le Yale Child Study Center, la Hannover Medical School et le Tel Aviv Sourasky Medical Center. L'entreprise a déjà obtenu les approbations nécessaires des comités d'examen institutionnels et des autorités sanitaires pertinentes.
L'essai vise à évaluer l'efficacité, la sécurité et la tolérabilité de SCI-110 chez les patients adultes âgés de 18 à 65 ans. Les participants seront randomisés pour recevoir soit SCI-110 soit un placebo. L'objectif principal d'efficacité est d'évaluer le changement de la sévérité des tics à l'aide de l'échelle Yale Global Tic Severity Scale aux semaines 12 et 26 par rapport à la valeur de référence. L'objectif de sécurité se concentre sur la surveillance des effets indésirables dans les deux groupes de traitement.
SciSparc (Nasdaq: SPRC) hat der FDA einen Antrag auf ein Neues Arzneimittel zur Erforschung für eine klinische Studie der Phase IIb des SCI-110 gestellt, eine eigene Behandlung für das Tourette-Syndrom. Die Studie wird an drei führenden Zentren durchgeführt: Yale Child Study Center, Hannover Medical School und Tel Aviv Sourasky Medical Center. Das Unternehmen hat bereits die erforderlichen Genehmigungen von den Institutional Review Boards und den zuständigen Gesundheitsbehörden eingeholt.
Die Studie zielt darauf ab, die Wirksamkeit, Sicherheit und Verträglichkeit von SCI-110 bei erwachsenen Patienten im Alter von 18 bis 65 Jahren zu bewerten. Die Teilnehmer werden randomisiert entweder SCI-110 oder ein Placebo erhalten. Das primäre Ziel der Wirksamkeit besteht darin, die Veränderung der Tic-Schwere mit der Yale Global Tic Severity Scale in den Wochen 12 und 26 im Vergleich zur Grundlinie zu bewerten. Das Sicherheitsziel konzentriert sich auf die Überwachung von unerwünschten Ereignissen in beiden Behandlungsgruppen.
- Submission of IND application to FDA for phase IIb clinical trial
- Secured approvals from institutional review boards and health authorities
- Trial to be conducted at three globally recognized medical centers
- Clear trial design with defined efficacy and safety objectives
- None.
Insights
The submission of an IND application to the FDA for SciSparc's phase IIb clinical trial of SCI-110 in Tourette Syndrome (TS) is a significant milestone in the drug development process. This move indicates that the company has completed preclinical studies and is ready to begin human trials in the US. The multi-center, international nature of the study, involving prestigious institutions like Yale, adds credibility to the research.
The trial's design, a randomized, placebo-controlled study using the Yale Global Tic Severity Scale, is scientifically robust. The focus on both efficacy and safety over a 26-week period will provide comprehensive data on SCI-110's potential as a TS treatment. However, investors should note that phase IIb trials still carry significant risks and success is not guaranteed. The outcome of this trial will be important in determining SCI-110's future prospects.
This development represents a positive step for SciSparc's pipeline progression. Advancing to phase IIb trials typically indicates increased confidence in a drug's potential, which could positively impact investor sentiment. However, it's important to consider that clinical-stage pharmaceutical companies often face financial challenges as they progress through costly late-stage trials.
Investors should monitor SciSparc's cash burn rate and funding situation closely. While this news doesn't guarantee commercial success, it does potentially enhance the company's value proposition. The Tourette Syndrome market, while niche, could offer significant opportunities if SCI-110 proves effective. Nonetheless, prudent investors should balance this progress against the company's overall financial health and the inherent risks in drug development.
The Tourette Syndrome treatment market presents a significant unmet need, with effective therapies available. SciSparc's progress with SCI-110 could position the company favorably in this niche but potentially lucrative market. The involvement of renowned institutions in the trial may enhance the credibility of the results, potentially influencing future market adoption if the drug is approved.
However, it's important to note that market success depends not only on clinical efficacy but also on factors like pricing, reimbursement and competition. The oral administration of SCI-110 could be a competitive advantage if it proves effective, as patient-friendly dosing forms are often preferred. Investors should keep an eye on the competitive landscape and any emerging therapies for TS as SciSparc progresses through this critical phase of development.
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
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.
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.
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 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.
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 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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