SciSparc Announces Enrollment of the First Five Patients in the Clinical Trial of its Innovative SCI-210 Treatment
SciSparc (Nasdaq: SPRC) has announced the enrollment and dosing of the first five patients in its clinical trial for SCI-210, an innovative treatment for autism spectrum disorder (ASD). The trial, conducted at the Soroka Medical Center in Israel, is a double-blind, randomized, and placebo-controlled study involving 60 subjects aged 5-18 over 20 weeks. SCI-210 combines cannabidiol (CBD) with SciSparc's novel CannAmide™ formulation.
The study aims to compare SCI-210 therapy with standard CBD monotherapy in managing ASD symptoms. Primary efficacy metrics include the ABC-C parent questionnaire, CGI-I clinician assessment, and effective therapeutic dose. Following the trial, SciSparc plans to commercialize SCI-210 in Israel and potentially other countries, subject to regulatory approvals.
SciSparc (Nasdaq: SPRC) ha annunciato l'arruolamento e la somministrazione delle prime cinque pazienti nel suo studio clinico per SCI-210, un trattamento innovativo per il disturbo dello spettro autistico (ASD). Lo studio, condotto presso il Soroka Medical Center in Israele, è un studio in doppio cieco, randomizzato e controllato con placebo che coinvolge 60 soggetti di età compresa tra 5 e 18 anni per una durata di 20 settimane. SCI-210 combina il cannabidiolo (CBD) con la nuova formulazione CannAmide™ di SciSparc.
Lo studio ha l'obiettivo di confrontare la terapia SCI-210 con la monoterapia standard di CBD nella gestione dei sintomi dell'ASD. I principali parametri di efficacia includono il questionario ABC-C per i genitori, la valutazione CGI-I da parte dei medici e la dose terapeutica efficace. Al termine dello studio, SciSparc prevede di commercializzare SCI-210 in Israele e potenzialmente in altri paesi, a condizione di ricevute le approvazioni regolatorie.
SciSparc (Nasdaq: SPRC) ha anunciado la inscripción y dosificación de los primeros cinco pacientes en su ensayo clínico para SCI-210, un tratamiento innovador para el trastorno del espectro autista (ASD). El ensayo, realizado en el Soroka Medical Center en Israel, es un estudio doble ciego, aleatorizado y controlado con placebo que involucra a 60 sujetos de entre 5 y 18 años durante 20 semanas. SCI-210 combina cannabidiol (CBD) con la novedosa formulación CannAmide™ de SciSparc.
El estudio tiene como objetivo comparar la terapia SCI-210 con la monoterapia estándar de CBD en el manejo de los síntomas del ASD. Los principales métricas de eficacia incluyen el cuestionario ABC-C para padres, la evaluación CGI-I por parte del clínico, y la dosis terapéutica efectiva. Tras el ensayo, SciSparc planea comercializar SCI-210 en Israel y potencialmente en otros países, sujeto a aprobaciones regulatorias.
SciSparc (Nasdaq: SPRC)는 자폐 스펙트럼 장애(ASD)에 대한 혁신적인 치료법인 SCI-210에 대한 임상 시험에서 처음으로 다섯 명의 환자를 등록하고 투약했다고 발표했습니다. 이 시험은 이스라엘의 소로카 메디컬 센터에서 진행되며, 이중 맹검, 무작위화, 위약 대조 연구로 5세에서 18세 사이의 60명을 대상으로 20주간 진행됩니다. SCI-210은 칸나비디올(CBD)과 SciSparc의 새로운 CannAmide™ 제형을 결합합니다.
이 연구는 ASD 증상 관리에 있어 SCI-210요법과 표준 CBD 단일 요법을 비교하는 것을 목표로 합니다. 주요 효능 측정 지표는 ABC-C 부모 설문지, CGI-I 임상 평가 및 효과적인 치료 용량을 포함합니다. 시험 후 SciSparc는 이스라엘에서 SCI-210을 상용화할 계획이며, 잠재적으로 다른 나라에서도 규제 승인에 따라 상용화할 것입니다.
SciSparc (Nasdaq: SPRC) a annoncé l'inscription et la dosage des cinq premiers patients dans son essai clinique pour le SCI-210, un traitement innovant pour le trouble du spectre autistique (ASD). L'essai, réalisé au Soroka Medical Center en Israël, est une étude en double aveugle, randomisée et contrôlée par placebo impliquant 60 sujets âgés de 5 à 18 ans pendant 20 semaines. Le SCI-210 combine le cannabidiol (CBD) avec la nouvelle formulation CannAmide™ de SciSparc.
L'étude vise à comparer la thérapie avec le SCI-210 à la monothérapie standard au CBD dans la gestion des symptômes de l'ASD. Les principaux indicateurs d'efficacité comprennent le questionnaire parental ABC-C, l'évaluation CGI-I par le clinicien, et la dose thérapeutique efficace. À l'issue de l'essai, SciSparc prévoit de commercialiser le SCI-210 en Israël et potentiellement dans d'autres pays, sous réserve des approbations réglementaires.
SciSparc (Nasdaq: SPRC) hat die Einschreibung und Dosierung der ersten fünf Patienten in seiner klinischen Studie für SCI-210, eine innovative Behandlung für Autismus-Spektrum-Störungen (ASD), bekannt gegeben. Die Studie, die im Soroka Medical Center in Israel durchgeführt wird, ist eine doppelt verblindete, randomisierte und placebo-kontrollierte Studie, an der 60 Probanden im Alter von 5 bis 18 Jahren über 20 Wochen teilnehmen. SCI-210 kombiniert Cannabidiol (CBD) mit SciSparcs neuartiger CannAmide™-Formulierung.
Ziel der Studie ist es, die Therapie mit SCI-210 mit der Standard-CBD-Monotherapie zur Behandlung von ASD-Symptomen zu vergleichen. Die primären Wirksamkeitsmessungen umfassen den Elternfragebogen ABC-C, die CGI-I-Bewertung durch den Arzt und die effektive therapeutische Dosis. Nach der Studie plant SciSparc, SCI-210 in Israel und möglicherweise auch in anderen Ländern zu kommerzialisieren, vorbehaltlich der behördlichen Genehmigungen.
- Enrollment of first five patients in SCI-210 clinical trial for ASD treatment
- Innovative combination of CBD and CannAmide™ in SCI-210 formulation
- Planned commercialization of SCI-210 in Israel and potentially other markets
- None.
Insights
The enrollment of the first five patients in SciSparc's clinical trial for SCI-210 marks a significant milestone in ASD research. This innovative combination of CBD and CannAmide™ could potentially offer a new treatment option for managing ASD symptoms. The double-blind, randomized, placebo-controlled design adds credibility to the study, while the
The trial's focus on children aged 5-18 is particularly noteworthy, as early intervention is important in ASD management. The use of three primary efficacy metrics (ABC-C, CGI-I and effective therapeutic dose) will provide a comprehensive assessment of the treatment's impact. However, investors should note that positive results are not guaranteed and the commercialization process will depend on regulatory approvals beyond Israel.
SciSparc's progress with SCI-210 positions the company at the forefront of ASD treatment research. The potential market for an effective ASD therapy is substantial, given the lifelong nature of the disorder and the current lack of targeted treatments. If successful, SCI-210 could become a first-in-class therapy, potentially capturing a significant market share.
Investors should consider the following factors:
- The 60-subject trial size is relatively small, which may limit the statistical power of the results.
- The collaboration with the National Autism Research Center adds credibility to the study design.
- The company's plan to commercialize first in Israel before expanding globally is a prudent approach, allowing for a controlled market entry.
While promising, it's important to note that many CNS-focused drug candidates face challenges in later-stage trials and regulatory approvals.
The clinical trial for SCI-210 is conducted in Israel, after which the Company aims to move forward with the commercialization process of SCI-210, first in the Israeli market
TEL AVIV, Israel, Aug. 19, 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 of the central nervous system, today announced that the first five patients have been enrolled and dosed into its ongoing clinical trial in children suffering from autism spectrum disorder ("ASD") at the Soroka Medical Center in Israel.
The double-blind, randomized and placebo-controlled trial uses SciSparc's proprietary SCI-210, an innovative combination comprising cannabidiol (“CBD”) and CannAmide™ (SciSparc’s novel Palmitoylethanolamide formulation), which is designed to alleviate ASD symptoms. SciSparc will enroll 60 subjects between the ages of five and 18 for 20 weeks, with the purpose of assessing how SCI-210 therapy compares to standard CBD monotherapy in managing symptoms of ASD.
The Company's goal is to sell SCI-210 first in Israel and then in other countries, subject to obtaining the requisite regulatory approvals.
The trial has three primary efficacy metrics: the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire; the Clinical Global Impressions-Improvement (CGI-I) performed by a clinician; and the effective therapeutic dose. The trial was designed in consultation with the National Autism Research Center, the leading research center for autism in Israel.
“People of all genders, ethnicities and economic backgrounds can be diagnosed with ASD. Although ASD can be a lifelong disorder, treatments and services can improve a person’s symptoms and daily functioning. Consistent with our mission of improving people’s lives, we are happy with the ongoing pace of enrollment in the SCI-210 trial and expect that this study will generate new scientific data so that others may be better helped in the future,” said Oz Adler, SciSparc’ s Chief Executive Officer.
ASD is a condition related to brain development that impacts how a person perceives and socializes with others, causing problems in social interaction and communication. The term "spectrum" in ASD refers to the wide range of symptoms and severity.
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; SCI-160 for the treatment of pain; 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 expected progress and design of the clinical trial, its expected commercialization strategy and its view on the progress and effect of the clinical study. 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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