Israel-based pharma company SciSparc has kicked off a trial evaluating its SCI-210 compound in children and adolescents with autism spectrum disorder (ASD).

The company announced the first patient was dosed at the Soroka Medical Centre.

SciSparc’s compound combines cannabidiol (CBD) oil with the company’s CannAmide (palmitoylethanolamide, PEA) tablets. Using the so-called “entourage effect,” the efficacy of CBD is enhanced.

According to the ClinicalTrials.gov entry, PEA could enhance anandamide responses in non-vascular tissues. This means that CBD oil in addition to PEA is more effective than CBD oil alone.

Research suggests that PEA supplementation is associated with neuroprotective and anti-inflammatory properties and can reduce overall autism severity by improving language and social and non-social behaviours.

SciSpark’s randomized, double-blind, sparing-effect, placebo-controlled trial will test the compound in an estimated 60 patients aged between five and 18 years with ASD.

Oral CBD oil and CannAmide pills at 400mg will be administrated twice daily to patients and compared to a group receiving CBD oil as a monotherapy.

This is the first clinical trial for SCI-210, but SciSpark cites previous anecdotal evidence indicating its benefit in ASD patients.

The trial’s primary endpoints include safety and efficacy evaluations throughout a 24-week period.

SciSpark began recruiting for the trial in January this year. In a release at the time, the company said the trial was designed in partnership with Israel’s National Autism Research Centre.

SciSpark’s CEO Oz Adler said: “We are thrilled to reach this milestone, which brings us one step closer to potentially offering a new beacon of hope for patients and families affected by ASD. This achievement represents a pivotal 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 rocky regulatory road in the US. While it is fully legal in some states, others permit its use in medicine under certain criteria such as oil concentration and type of condition being treated.

Jaguar Gene Therapy received FDA clearance in January 2024 to start a trial investigating a gene therapy for a genetic form of ASD.