Research suggests that PEA supplementation is associated with neuroprotective and anti-inflammatory properties. Image credit: Shutterstock/Kitreel.
Israeli pharmaceutical company SciSparc has started a trial evaluating its compound SCI-210 in children and adolescents with autism spectrum disorder (ASD).
The company announced that the first patient was dosed at the Soroka Medical Center.
SciSparc’s compound combines cannabidiol (CBD) oil with the company’s CannAmide (palmitoylethanolamide, PEA) tablets. By means of the so-called “surrounding effect”, the effectiveness of CBD is enhanced.
According to the ClinicalTrials.gov entry, PEA could enhance anandamide responses in nonvascular tissues. This means that CBD oil plus PEA is more effective than CBD oil alone.
Research suggests that PEA supplementation is associated with neuroprotective and anti-inflammatory properties and may reduce the overall severity of autism by improving language and social and non-social behaviors.
SciSpark’s randomized, double-blind, placebo-controlled trial will test the compound in about 60 patients aged five to 18 with ASD.
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Oral CBD oil and CannAmide 400 mg pills will be administered twice daily to patients and compared to a group receiving CBD oil as monotherapy.
This is the first clinical trial for SCI-210, but SciSpark cites previous anecdotal evidence indicating its benefit in ASD patients.
The primary objectives of the trial include safety and efficacy assessments over a 24-week period.
SciSpark began recruiting for the trial in January this year. In a statement at the time, the company said the trial was designed in collaboration with Israel’s National Autism Research Center.
SciSpark CEO Oz Adler said, “We are thrilled to reach this milestone, which brings us one step closer to potentially providing a new beacon of hope for patients and families affected by ASD. This achievement represents a key moment for SciSparc as we introduce SCI-210, an innovative cannabinoid-based treatment.”
Janssen’s Risperdal (risperidone) and Bristol-Myers Squibb/Otsuka’s Abilify (aripiprazole) are the only two drugs approved by the US Food and Drug Administration (FDA) for ASD in children.
CBD has had a difficult regulatory path in the US. Although it is completely legal in some states, others allow its use in medicine under certain criteria, such as the concentration of the oil and the type of disease being treated.
Jaguar Gene Therapy received FDA clearance in January 2024 to begin a trial investigating gene therapy for a genetic form of ASD.
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