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SciSparc Announces Israeli Ministry of Health Approval to Conduct its Clinical Trial in Autism Spectrum Disorder
The trial's objectives are to evaluate the safety, tolerability and efficacy of SciSparc's SCI-210 in children and adolescents with ASD TEL AVIV, Israel, Aug.
About this update from Scisparc Ltd.
[{"type":"text","content":"The trial's objectives are to evaluate the safety, tolerability and efficacy of SciSparc's SCI-210 in children and adolescents with ASD TEL AVIV, Israel, Aug. 08, 2022 (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 it has received approval from the Israeli Ministry of Health to conduct the Company’s clinical trial for SCI-210 in patients suffering from autism spectrum disorder (\"ASD\"). Recently, the Company announced it received approval from the Ethics Committee of The Soroka University Medical Center, in Be'er-Sheva, Israel, to conduct the Company’s clinical trial. “We are pleased to achieve another important milestone that brings us one step closer toward initiation of our clinical trial in ASD,” commented Oz Adler, SciSparc's Chief Executive Officer. \"ASD symptoms in pediatric patients may cause a sever decrease in life quality, for parents and children. We believe that our unique and proprietary SCI-210 has the potential to be a new treatment to reduce irritability and other conditions associated with ASD. Patients today have limited treatment options while the need for such treatment rapidly grows. Our drug candidates potentially enable us to provide effective, safer and more tolerable treatment with fewer side effects thanks to the lower doses of cannabinoids, boosted by the combination with CannAmide™, a mission always desirable but even more so when children are the target population.\" The trial will investigate the effect of the Company’s drug candidate SCI-210, a proprietary combination of cannabidiol (“CBD”) and CannAmide™, versus CBD monotherapy in treating ASD. The trial's objectives are to evaluate the safety, tolerability and efficacy of SCI-210 in children and adolescents with ASD in a designed 20-week, randomized, double-blind, placebo controlled with a cross-over clinical trial of 60 children. The trial has three primary efficacy end points: 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. ASD is a condition related to brain development that impacts how a person perceives and soci...