SciSparc Secures FDA Green Light to US Launch of its Pivotal Phase IIb Clinical Trial for Breakthrough Tourette Syndrome Treatment
SciSparc (Nasdaq: SPRC) has received FDA approval to proceed with its Phase IIb clinical trials in the U.S. for SCI-110, a potential breakthrough treatment for Tourette Syndrome (TS) in adults. This approval comes just one month after the application submission, marking a significant milestone for the company. The trial will be conducted at three leading centers: Yale Child Study Center, 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 primary efficacy objective is to assess tic severity change using the Yale Global Tic Severity Scale at weeks 12 and 26 compared to baseline. SciSparc's CEO, Oz Adler, emphasized the unmet medical need for TS management and highlighted the promising results from their Phase IIa trial, which showed an average tic reduction of 21% across the entire sample.
SciSparc (Nasdaq: SPRC) ha ricevuto l'approvazione della FDA per procedere con i suoi studi clinici di fase IIb negli Stati Uniti per SCI-110, un potenziale trattamento rivoluzionario per la Sindrome di Tourette (TS) negli adulti. Questa approvazione arriva solo un mese dopo la presentazione della domanda, segnando un traguardo significativo per l'azienda. Lo studio sarà condotto in tre centri di riferimento: Yale Child Study Center, Hannover Medical School e Tel Aviv Sourasky Medical Center.
Lo studio 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. L'obiettivo principale di efficacia è valutare il cambiamento della gravità dei tic utilizzando la Yale Global Tic Severity Scale nelle settimane 12 e 26 rispetto al valore di partenza. Il CEO di SciSparc, Oz Adler, ha sottolineato il bisogno medico non soddisfatto nella gestione della TS ed evidenziato i risultati promettenti del loro trial di fase IIa, che ha mostrato una riduzione media dei tic del 21% nell'intero campione.
SciSparc (Nasdaq: SPRC) ha recibido la aprobación de la FDA para proceder con sus ensayos clínicos de fase IIb en EE. UU. para SCI-110, un posible tratamiento revolucionario para el Síndrome de Tourette (TS) en adultos. Esta aprobación llega solo un mes después de la presentación de la solicitud, marcando un hito significativo para la compañía. El ensayo se llevará a cabo en tres centros líderes: Yale Child Study Center, Hannover Medical School y Tel Aviv Sourasky Medical Center.
El estudio tiene como objetivo evaluar la eficacia, seguridad y tolerabilidad de SCI-110 en pacientes adultos de 18 a 65 años. 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 base. El CEO de SciSparc, Oz Adler, enfatizó la necesidad médica no satisfecha en el manejo de la TS y destacó los resultados prometedores de su ensayo de fase IIa, que mostró una reducción promedio de los tics del 21% en toda la muestra.
SciSparc (Nasdaq: SPRC)는 SCI-110에 대한 2b상 임상 시험을 진행하기 위해 FDA의 승인을 받았습니다. SCI-110은 성인에서 투렛 증후군(Tourette Syndrome, TS)을 위한 잠재적인 혁신 치료법입니다. 이 승인은 신청서 제출 한 달 만에 이루어졌으며, 이는 회사에 있어 중요한 이정표입니다. 시험은 세 개의 주요 센터인 예일 아동 연구 센터, 하노버 의과대학 및 텔아비브 소라스키 의과대학에서 진행될 예정입니다.
이 연구는 18세에서 65세의 성인 환자에서 SCI-110의 효능, 안전성 및 내약성을 평가하는 것을 목표로 합니다. 주요 효능 목표는 12주와 26주에 걸쳐 Yale Global Tic Severity Scale를 사용하여 틱의 중증도 변화를 기준선과 비교하는 것입니다. SciSparc의 CEO인 Oz Adler는 TS 관리에서 충족되지 않은 의학적 필요성과 함께 2a상 시험에서 나타난 평균 21%의 틱 감소를 보여준 유망한 결과를 강조했습니다.
SciSparc (Nasdaq: SPRC) a reçu l'approbation de la FDA pour procéder à ses essais cliniques de phase IIb aux États-Unis pour SCI-110, un traitement potentiel révolutionnaire pour le syndrome de Tourette (TS) chez les adultes. Cette approbation intervient seulement un mois après la soumission de la demande, marquant une étape importante pour la société. L'essai sera réalisé dans trois centres de premier plan : le Yale Child Study Center, la Hannover Medical School et le Tel Aviv Sourasky Medical Center.
L'étude vise à évaluer l'efficacité, la sécurité et la tolérabilité de SCI-110 chez des patients adultes âgés de 18 à 65 ans. 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 valeur de base. Le PDG de SciSparc, Oz Adler, a souligné le besoin médical non satisfait dans la gestion du TS et a mis en avant les résultats prometteurs de leur essai de phase IIa, qui a montré une réduction moyenne des tics de 21 % dans l'échantillon total.
SciSparc (Nasdaq: SPRC) hat die Genehmigung der FDA erhalten, um mit seinen klinischen Phase-IIb-Studien in den USA für SCI-110 fortzufahren, einer potenziellen bahnbrechenden Behandlung für das Tourette-Syndrom (TS) bei Erwachsenen. Diese Genehmigung erfolgt nur einen Monat nach Einreichung des Antrags und markiert einen bedeutenden Meilenstein für das Unternehmen. Die Studie wird an drei führenden Zentren durchgeführt: Yale Child Study Center, Hannover Medical School und 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 bewerten. Das primäre Wirksamkeitsziel besteht darin, die Veränderung der Tic-Schwere anhand der Yale Global Tic Severity Scale in den Wochen 12 und 26 im Vergleich zur Basislinie zu bewerten. Der CEO von SciSparc, Oz Adler, betonte den unerfüllten medizinischen Bedarf für das Management von TS und hob die vielversprechenden Ergebnisse ihrer Phase-IIa-Studie hervor, die eine durchschnittliche Tic-Reduktion von 21 % in der gesamten Stichprobe zeigte.
- FDA approval to proceed with Phase IIb clinical trials for SCI-110 in the U.S.
- Rapid FDA response, approving the study only one month after application submission
- Phase IIa trial results showed an average tic reduction of 21%, with 40% of patients experiencing over 25% tic reduction
- Trial to be conducted at three globally recognized medical centers
- Institutional Review Board approvals secured from all three clinical sites
- None.
Insights
The FDA's approval for SciSparc's Phase IIb clinical trial for SCI-110 in Tourette Syndrome (TS) is a significant milestone. This rapid approval, just one month after submission, suggests the FDA sees potential in this novel treatment approach. The trial's design, involving three prestigious international centers, adds credibility to the study.
The Phase IIa results showing an average 21% tic reduction, with 40% of patients experiencing >25% reduction, are promising. These outcomes address a clear unmet need in TS treatment, where current options have efficacy and safety concerns.
The Phase IIb study's focus on both efficacy and safety, using the well-established Yale Global Tic Severity Scale, will provide important data. If successful, SCI-110 could potentially disrupt the current TS treatment landscape, offering a more effective and safer alternative.
For investors, this development represents a significant de-risking event for SciSparc's lead program. However, it's important to note that Phase IIb results are still needed to confirm the treatment's potential and the path to market remains long.
This FDA approval for SciSparc's Phase IIb trial is a positive catalyst for the company's valuation. With a market cap of just
The global Tourette Syndrome therapeutics market is projected to reach
Investors should note that clinical-stage biotech companies often experience significant volatility around trial milestones. While this news is positive, the company will likely need additional funding to complete the Phase IIb trial and potential Phase III studies. This could lead to dilution for current shareholders.
The involvement of prestigious research institutions may increase the likelihood of positive results and could attract potential partnerships or buyout offers from larger pharmaceutical companies, potentially providing significant upside for early investors.
FDA confirms that SciSparc’s study may proceed only a month after application submission
TEL AVIV, Israel, Sept. 30, 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, 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”). This previously announced FDA approval is one of the most important milestones of SciSparc to date.
Oz Adler, Chief Executive Officer of SciSparc, commented “As the currently used medications are managing only a small number of disease symptoms with limited efficacy and questionable safety, we believe there is a clear unmet medical need for the management of TS. The desired therapy for TS should allow for a notable effectiveness, addressing as many symptoms as possible. The therapy of choice should also have a favorable safety profile, allowing for a high patient’s drug compliance. In light of the results from our Phase IIa clinical trial conducted at Yale University that showed an average tic reduction of
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.
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: its belief regarding an unmet medical need for the management of TS; the parameters for the desired therapy for TS; its belief that its innovative drug candidate SCI-110 has the potential to become the desired therapy for TS; 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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