SciSparc Announces Renewal of Approval by Israeli Medical Cannabis Agency for its Clinical Trial in Children with Autism Spectrum Disorder
SciSparc (SPRC) has received renewal approval from the Israeli Medical Cannabis Agency for its clinical trial of SCI-210 in children with autism spectrum disorder (ASD). The 30-day approval will be extended pending final approval from the Israeli police department. The trial is a double-blind, randomized, placebo-controlled study at Soroka University Medical Center, involving 60 children aged 5-18 with ASD.
The study will evaluate SCI-210, a combination of CBD and CannAmide™, against standard CBD monotherapy over a 20-week treatment period. Primary efficacy metrics include the ABC-C parent questionnaire and CGI-I scale. The company plans to initially commercialize SCI-210 in Israel before expanding internationally, subject to regulatory approvals.
SciSparc (SPRC) ha ricevuto l'approvazione per il rinnovo da parte dell'Agenzia israeliana per la cannabis medica per il suo studio clinico su SCI-210 in bambini con disturbo dello spettro autistico (ASD). L'approvazione di 30 giorni sarà estesa in attesa dell'approvazione finale da parte del dipartimento di polizia israeliano. Lo studio è un trial clinico randomizzato, in doppio cieco e controllato con placebo presso il Centro Medico Universitario Soroka, che coinvolge 60 bambini di età compresa tra 5 e 18 anni con ASD.
Lo studio valuterà SCI-210, una combinazione di CBD e CannAmide™, rispetto alla monoterapia standard con CBD per un periodo di trattamento di 20 settimane. I principali parametri di efficacia includono il questionario ABC-C dei genitori e la scala CGI-I. L'azienda prevede di commercializzare inizialmente SCI-210 in Israele prima di espandersi a livello internazionale, soggetto ad approvazioni regolatorie.
SciSparc (SPRC) ha recibido la aprobación de renovación de la Agencia Israelí de Cannabis Medicinal para su ensayo clínico de SCI-210 en niños con trastorno del espectro autista (ASD). La aprobación de 30 días se extenderá a la espera de la aprobación final del departamento de policía israelí. El ensayo es un estudio controlado aleatorio, en doble ciego y con placebo en el Centro Médico Universitario Soroka, que involucra a 60 niños de 5 a 18 años con ASD.
El estudio evaluará SCI-210, una combinación de CBD y CannAmide™, en comparación con la monoterapia estándar de CBD durante un período de tratamiento de 20 semanas. Los principales parámetros de eficacia incluyen el cuestionario ABC-C para padres y la escala CGI-I. La empresa planea comercializar inicialmente SCI-210 en Israel antes de expandirse internacionalmente, sujeto a aprobaciones regulatorias.
SciSparc (SPRC)는 이스라엘 의료 대마초 기관으로부터 자폐 스펙트럼 장애(ASD)가 있는 아동을 대상으로 한 SCI-210의 임상 시험 갱신 승인을 받았습니다. 30일 승인 기간은 이스라엘 경찰청의 최종 승인이 남아 있어 연장될 것입니다. 본 시험은 이중 맹검, 무작위 배정, 위약 대조 연구로서, 5세에서 18세까지의 ASD 아동 60명을 포함하여 소로카 대학교 의료 센터에서 진행됩니다.
이번 연구는 CBD와 CannAmide™의 조합인 SCI-210을 20주 치료 기간 동안 표준 CBD 단일 요법과 비교하여 평가할 것입니다. 주요 효능 지표로는 ABC-C 부모 설문지와 CGI-I 척도가 포함됩니다. 회사는 규제 승인을 조건으로 SCI-210을 이스라엘에서 최초로 상용화한 후 국제적으로 확장할 계획입니다.
SciSparc (SPRC) a reçu l'approbation de renouvellement de l'Agence israélienne de la cannabis médical pour son essai clinique sur SCI-210 chez des enfants atteints de troubles du spectre autistique (TSA). L'approbation de 30 jours sera prolongée en attendant l'approbation finale du département de police israélien. L'étude est un essai contrôlé randomisé en double aveugle avec placebo mené au Centre Médical Universitaire Soroka, impliquant 60 enfants âgés de 5 à 18 ans avec TSA.
L'étude évaluera SCI-210, une combinaison de CBD et de CannAmide™, par rapport à la monothérapie standard au CBD sur une période de traitement de 20 semaines. Les principaux critères d'efficacité comprennent le questionnaire ABC-C pour les parents et l'échelle CGI-I. L'entreprise prévoit de commercialiser SCI-210 dans un premier temps en Israël avant de s'étendre à l'international, sous réserve des approbations réglementaires.
SciSparc (SPRC) hat die Genehmigung zur Erneuerung von der israelischen medizinischen Cannabis-Agentur für seine klinische Studie zu SCI-210 bei Kindern mit autistischen Spektrumstörungen (ASD) erhalten. Die 30-tägige Genehmigung wird verlängert, während auf die endgültige Genehmigung der israelischen Polizei gewartet wird. Die Studie ist eine doppelblinde, randomisierte, placebo-kontrollierte Studie am Soroka Universität medizinischen Zentrum, die 60 Kinder im Alter von 5 bis 18 Jahren mit ASD umfasst.
Die Studie wird SCI-210, eine Kombination aus CBD und CannAmide™, über einen Zeitraum von 20 Wochen gegen die Standard-CBD-Monotherapie bewerten. Die primären Wirksamkeitskennzahlen umfassen den Eltern-Fragebogen ABC-C und die CGI-I-Skala. Das Unternehmen plant, SCI-210 zunächst in Israel zu kommerzialisieren, bevor es international expandiert, vorbehaltlich behördlicher Genehmigungen.
- Received renewed regulatory approval for ASD clinical trial
- Previous approvals secured from Soroka University Medical Center Ethics Committee
- Clear commercialization pathway starting with Israeli market
- Short 30-day approval period requiring extension
- Additional police department approval still pending
- No immediate revenue potential as still in clinical trial phase
Insights
The renewal of IMCA approval for SciSparc's clinical trial represents a critical regulatory milestone in the development of SCI-210. The double-blind, randomized, placebo-controlled study design is the gold standard for clinical research, which strengthens the potential validity of future results. The trial's scope of 60 participants aged 5-18 provides a reasonable sample size for initial efficacy assessment.
The combination therapy approach of CBD with CannAmide™ is particularly noteworthy. While CBD has shown promise in ASD symptom management, the addition of Palmitoylethanolamide (PEA) through CannAmide™ could potentially enhance therapeutic effects through the 'entourage effect' - where multiple compounds work synergistically. The 20-week treatment duration is sufficient to evaluate both short-term safety and preliminary efficacy.
The use of validated assessment tools like ABC-C and CGI-I will provide quantifiable data points for measuring therapeutic impact. However, investors should note that this is still an early-stage trial and successful completion is required before any market potential can be realized.
For a micro-cap company with a market capitalization of approximately
The collaboration with Israel's National Autism Research Center adds credibility and expertise to the trial design. Success in this trial could position SciSparc favorably in the growing medical cannabis and CNS therapeutics sectors. The 30-day approval window with expected police department clearance indicates standard regulatory progression rather than any concerning delays.
However, investors should consider that commercialization is still distant, requiring successful trial completion, regulatory approvals and significant capital for market entry. The company's small market cap suggests resources, which may necessitate additional funding rounds that could impact share value.
TEL AVIV, Israel, Dec. 31, 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 the renewal of its approval from the Israeli Medical Cannabis Agency ("IMCA") at the Israeli Ministry of Health to conduct its clinical trial for SCI-210 in children with autism spectrum disorder ("ASD"). SCI-210 is a proprietary combination of cannabidiol (“CBD”) and CannAmide™.
This renewal reaffirms the Company's compliance with IMCA regulatory requirements and enables the continued progression of its clinical trial. The approval was received for a period of 30 days and will be extended pending the final approval by the Israeli police department, which is expected to be received within 30 days. SciSparc has also previously received the necessary approvals from the Soroka University Medical Center Ethics Committee and the Israeli Ministry of Health to conduct the trial, advancing its innovative treatments for ASD.
The clinical trial for SCI-210 is a double-blind, randomized, and placebo-controlled study conducted at Soroka University Medical Center in Israel, involving 60 children aged 5 to 18 with ASD. The trial aims to evaluate the efficacy and safety of SCI-210, a proprietary combination of CBD and CannAmide™ (SciSparc's novel Palmitoylethanolamide formulation), compared to standard CBD monotherapy. Participants will undergo a 20-week treatment program, focusing on symptom management and therapeutic outcomes.
The study’s primary efficacy metrics include the Aberrant Behavior Checklist-Community (ABC-C) parent questionnaire, the Clinical Global Impressions-Improvement (CGI-I) scale, and the determination of an effective therapeutic dose. The Company believes that this trial, designed in consultation with Israel's National Autism Research Center, is expected to generate valuable data to advance treatment options for individuals with ASD.
With commercialization of SCI-210 planned first in the Israeli market and subsequent expansion internationally, subject to regulatory approvals, SciSparc is dedicated to offering innovative solutions that address the unmet needs of individuals with ASD and their families.
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 cannabidiol: SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer's disease and agitation; and SCI-210 for the treatment of autism 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 the the potential efficacy and safety of SCI-210, its expectation that the results of the clinical trial will generate valuable data to advance treatment options for individuals with ASD and the commercialization of SCI-210 in the Israeli and international market. 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 SEC. 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
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