SciSparc Submitted IND Application to the FDA for SCI-110 Phase IIb Clinical Trial for Patients with Tourette Syndrome
SciSparc (Nasdaq: SPRC) has submitted an Investigational New Drug (IND) application to the FDA for its phase IIb clinical trial of SCI-110, a potential treatment for Tourette Syndrome (TS). The trial will be conducted at three leading centers: Yale Child Study Center, Hannover Medical School, and Tel Aviv Sourasky Medical Center. SCI-110, composed of dronabinol and palmitoylethanolamide, aims to address challenges in current TS treatments.
The study will evaluate the efficacy, safety, and tolerability of SCI-110 in adult patients aged 18-65. 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 trial's primary safety objective is to assess the frequency of serious adverse events.
SciSparc (Nasdaq: SPRC) ha presentato una domanda di Nuovo Farmaco in Sperimentazione (IND) alla FDA per il suo trial clinico di fase IIb di SCI-110, un potenziale trattamento per la Sindrome di Tourette (TS). Lo studio sarà condotto in tre centri di eccellenza: Yale Child Study Center, Hannover Medical School e Tel Aviv Sourasky Medical Center. SCI-110, composto da dronabinolo e palmitoilethanolamide, mira a risolvere le sfide nei trattamenti attuali per la TS.
Lo studio valuterà 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 principale di efficacia è valutare il cambiamento nella gravità dei tic utilizzando la Yale Global Tic Severity Scale nelle settimane 12 e 26 rispetto al valore iniziale. L'obiettivo principale di sicurezza dello studio è valutare la frequenza degli eventi avversi gravi.
SciSparc (Nasdaq: SPRC) ha presentado una solicitud de Nuevo Medicamento en Investigación (IND) a la FDA para su ensayo clínico de fase IIb de SCI-110, un posible tratamiento para el Síndrome de Tourette (TS). El estudio se llevará a cabo en tres centros líderes: Yale Child Study Center, Hannover Medical School y Tel Aviv Sourasky Medical Center. SCI-110, compuesto de dronabinol y palmitoiletanolamina, tiene como objetivo abordar los desafíos en los tratamientos actuales para la TS.
El estudio evaluará la eficacia, seguridad y tolerabilidad de SCI-110 en pacientes adultos de 18 a 65 años. Los participantes serán aleatorizados para recibir SCI-110 o un placebo. El objetivo principal 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 de base. El objetivo principal de seguridad del ensayo es evaluar la frecuencia de eventos adversos graves.
SciSparc (Nasdaq: SPRC)는 SCI-110의 2b상 임상 시험을 위한 신약 검사 요청서(IND)를 FDA에 제출했습니다. SCI-110은 투렛 증후군 (TS)의 잠재적인 치료제입니다. 이 임상 시험은 예일 아동 연구 센터, 하노버 의과대학 및 텔아비브 소라스키 의과대학의 세 곳에서 진행됩니다. SCI-110은 드로나비놀과 팔미토일에탄올아민으로 구성되어 있으며, 현재 TS 치료에서의 문제를 해결하는 것을 목표로 하고 있습니다.
이 연구는 18세에서 65세 사이의 성인 환자에서 SCI-110의 효능, 안전성 및 내약성을 평가합니다. 참가자는 SCI-110 또는 위약을 받도록 무작위로 배정됩니다. 주 효과 목표는 12주 및 26주 차에 예일 글로벌 틱 중증도 척도를 사용하여 틱 중증도의 변화를 평가하는 것입니다. 임상 시험의 주요 안전성 목표는 심각한 부작용의 빈도를 평가하는 것입니다.
SciSparc (Nasdaq: SPRC) a soumis une demande de Nouvel Médicament à l'EJD pour son essai clinique de phase IIb de SCI-110, un traitement potentiel pour le Syndrome de Tourette (TS). L'essai sera réalisé dans trois centres de référence : le Yale Child Study Center, l'Hannover Medical School et le Tel Aviv Sourasky Medical Center. SCI-110, composé de dronabinol et de palmitoïléthanolamine, vise à surmonter les défis des traitements actuels du TS.
L'étude évaluera l'efficacité, la sécurité et la tolérabilité de SCI-110 chez des 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 gravité des tics en utilisant l'échelle Yale Global Tic Severity Scale aux semaines 12 et 26 par rapport à la ligne de base. L'objectif principal de sécurité de l'essai est d'évaluer la fréquence des événements indésirables graves.
SciSparc (Nasdaq: SPRC) hat einen Antrag auf einen investigational new drug (IND) bei der FDA für seine Phase-IIb-Studie zu SCI-110 gestellt, einer potenziellen Behandlung für das Tourette-Syndrom (TS). Die Studie wird an drei führenden Zentren durchgeführt: Yale Child Study Center, Hannover Medical School und Tel Aviv Sourasky Medical Center. SCI-110, das aus Dronabinol und Palmitoylethanolamid besteht, zielt darauf ab, Herausforderungen in der aktuellen TS-Behandlung zu begegnen.
Die Studie wird die Wirksamkeit, Sicherheit und Verträglichkeit von SCI-110 bei erwachsenen Patienten im Alter von 18 bis 65 Jahren bewerten. Die Teilnehmer werden zufällig auf SCI-110 oder ein Placebo verteilt. Ziel der Wirksamkeit ist es, die Schwere der Tics anhand der Yale Global Tic Severity Scale in den Wochen 12 und 26 im Vergleich zur Ausgangsbasis zu bewerten. Das primäre Sicherheitsziel der Studie besteht darin, die Häufigkeit schwerwiegender unerwünschter Ereignisse zu bewerten.
- Submission of IND application to FDA for phase IIb clinical trial
- Collaboration with three globally recognized research centers
- Secured Institutional Review Board approvals from all three clinical sites
- Obtained approval from Israeli Ministry of Health and German Federal Institute for Drugs and Medical Devices
- None.
Insights
The submission of an IND application to the FDA for SCI-110's Phase IIb clinical trial marks a significant milestone for SciSparc in the development of a potential new treatment for Tourette Syndrome (TS). This move positions the company at the forefront of addressing an unmet medical need, as current TS treatments often have limitations.
The trial's design, involving three prestigious international medical centers, adds credibility and potentially increases the likelihood of producing robust, globally relevant data. The primary efficacy measure using the Yale Global Tic Severity Scale is a standard and well-respected metric in TS research, which should provide clear, comparable results.
However, investors should note that this is still a phase IIb trial, meaning there's a considerable journey ahead before potential FDA approval and commercialization. The focus on both efficacy and safety is crucial, as any adverse events could significantly impact the drug's future prospects.
While the IND submission is a positive step for SciSparc, it's important to temper expectations. The company is still in the clinical-stage phase, which typically implies no immediate revenue from this product line. Investors should be prepared for a potentially long runway before commercialization, if successful.
The multi-center, international approach to the trial could lead to increased R&D expenses in the short term. However, this strategy may pay off by potentially accelerating the path to market in multiple regions simultaneously, if the trial yields positive results.
Given SciSparc's focus on CNS disorders, success in this trial could validate their platform and potentially increase investor interest. However, it's important to consider the company's cash position and burn rate to ensure they can fund the trial to completion without significant dilution to shareholders.
The Tourette Syndrome treatment market presents a significant opportunity for SciSparc. With effective treatments available, a successful novel therapy could capture substantial market share. The global TS market was valued at
SciSparc's approach using a combination of dronabinol and palmitoylethanolamide is innovative and aligns with growing interest in cannabinoid-based therapies. This could potentially differentiate SCI-110 in a market dominated by traditional antipsychotics and alpha-2 agonists.
However, market acceptance will depend not only on efficacy but also on the safety profile and potential advantages over existing treatments. The inclusion of adult patients only (18-65 years) in this trial may limit initial market potential, as TS often begins in childhood. Future pediatric studies might be necessary to fully capitalize on the market opportunity.
SciSparc to conduct the trial at the 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
TEL AVIV, Israel, Aug. 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 the submission of an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for its phase IIb clinical trial for its proprietary SCI-110 for the treatment of Tourette Syndrome (“TS”).
“SciSparc is in a unique position to address the challenges associated with current TS treatments,” said SciSparc’s Chief Executive Officer, Oz Adler. “We believe that our proprietary SCI-110, comprised of dronabinol and palmitoylethanolamide, has the potential to revolutionize the way TS is treated. Commencing the clinical trial is the culmination of diligent work by the SciSparc team, together with leading researchers in the field.”
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 the Amazon.com 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 its belief that its SCI-110 has the potential to revolutionize the way TS is treated, 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: +972-3-6167055
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