SciSparc has secured approval from the Israeli Ministry of Health and Helsinki Committee to conduct a Phase IIa clinical trial of SCI-110 (formerly THX-110) for Alzheimer’s disease and agitation.

Based on the company’s cannabinoid-centric platform, SCI-110 combines Dronabinol and CannAmide.

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Dronabinol is a synthetic form of delta-9-tetrahydrocannabinol approved by the US Food and Drug Administration (FDA) while CannAmide is SciSparc’s palmitoylethanolamide (PEA) formulation.

In preclinical studies, the combination compounds developed using SciSparc cannabinoid-centric platform exhibited improved efficacy, reduced dosing needs and fewer side effects versus the cannabinoid alone.

The open-label Phase IIa trial will assess the safety, tolerability and efficacy of SCI-110 in this patient population. It will be performed at the Israeli Medical Center for Alzheimer’s.

SCI-110’s safety and ability to mitigate agitation and other behavioural disturbances in Alzheimer’s patients are the trial’s primary objectives.

SciSparc chief technologies officer Dr Adi Zuloff-Shani said: “Taken together, SCI-110’s assumed mechanism of action and clinical observations indicating that cannabis products, in particular THC, might ameliorate the severity of some of the behavioural and psychological symptoms of dementia such as agitation and anxiety, we believe that this trial will corroborate our belief that SCI-110 may constitute a safe and effective treatment for agitation in Alzheimer’s disease.”

An irreversible neurodegenerative disorder, Alzheimer’s is characterised by progressive and disabling impairment of cognitive functions such as memory, comprehension, attention and reasoning.

In the mid to late stages of the disease, common neuropsychiatric symptoms include social withdrawal, agitation, psychosis, insomnia, poor appetite and wandering.

The available pharmacological therapy for agitation caused by Alzheimer’s is off-label antipsychotic drugs and has an unfavourable benefit/risk ratio, the company noted.

Apart from Alzheimer’s, SCI-110 is being developed to treat patients with Tourette’s syndrome and obstructive sleep apnea.

Last month, Alzheon started dosing in its APOLLOE4 Phase III study evaluating the efficacy and safety of oral anti-amyloid drug ALZ-801 in early Alzheimer’s patients.