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Cannabis Agent SCI-110 Meets Primary End Points in Phase 2 Interim Analysis of Alzheimer Disease Agitation

SCI-110 not only met its primary safety end points, but the agent showed benefits on secondary outcomes such as need to use rescue medication and exploratory outcomes such as appetite.

Newly announced interim results from a phase 2a trial (NCT05239390) of SCI-110 (SciSparc), a cannabinoid-centric agent, in patients with Alzheimer disease (AD) and agitation showed that the agent was well-tolerated and met its primary and secondary end points. There are currently no FDA-approved therapies to treat the condition, which has shown to increase patients’ suffering and burden of care.1

The primary end points included drop-outs and number of study treatment-related adverse events (AE) for up to 64 days after initiation. SCI-110 contains a combination of dronabinol, an FDA-approved synthetic form of tetrahydrocannabinol (THC), with endocannabinoid Palmitoylethanolamide (PEA). The agent remains in development for other conditions such as Tourette Syndrome, autism spectrum disorder, epilepsy, obstructive sleep apnea, and AD pain.

"We are pleased that SCI-110 is showing clinically meaningful results and may provide a potential treatment option for Alzheimer’s patients with agitation," Adi Zuloff-Shani, PhD, chief technology officer, SciSparc, said in a statement.1 "These results further support our efforts to reimagine medicine in this challenging area and reach this underserved patient population."

The interim analysis, which included the first 8 patients of the expected 20-patient cohort who completed the study, was conducted at The Israeli Medical Center for Alzheimer’s under Alexander Kaplan, MD, board-certified geriatrician. In the study, the starting daily dose was 2.5 mg dronabinol and 800 mg PEA that was gradually increased every 3 days with an additional 2.5 mg of dronabinol per day and no change in the PEA dose. The maximum dose was 12.5 mg dronabinol and 800 mg PEA per day.

Screening was conducted from days 3 to 21, followed by a treatment phase that consisted of a titration stage (3-21 days), a stabilization phase (10 days) until the end of treatment on the highest individual’s tolerated dose, and a 7-day follow-up phase. Patients had to have a Mini-Mental State Examination (MMSE) score of less than 24 at the time of screening, had been taking stable dose concomitant medications for at least 1 week, and had medication to control agitation or current anti-agitation medication deemed ineffective or poorly tolerated.

In the open-label trial, 20 individuals, aged 60 to 85 years, no individuals experienced delirium, oversedation, hypotension, or falls in the highest dose of SCI-110 tested. Additionally, the agent met its secondary end point of change from baseline in agitation as measured by the Cohen Mansfield Agitation Inventory. Specifically, 6 of the 8 patients demonstrated amelioration in agitation with no need to use rescue medication to condition their condition.

Findings also showed that 6 of the 8 patients had increased appetite, an exploratory end point measured by Edinburgh Feeding Evaluation in Dementia Scale. No effect was observed for cognitive measurements and sleep quality, assessed by the MMSE and Alzheimer’s Disease Assessment Scale-Cognitive subscale, as well as the Pittsburgh Sleep Quality Index.

In July 2022, SciSparc announced it was in the process of submitting an investigational new drug application (IND) for a phase 2b trial to assess SCI-110 in Tourette Syndrome. The announced trial stemmed from results of a previously conducted phase 2a study, which showed that treatment using the therapy resulted in a 21% reduction of tic symptoms across a sample of patients with medically refractory TS. Additionally, the agent was proven to be safe, with no concerning AEs, and improved patients’ tic symptoms over time on the Yale Global Tic Severity Scale.2

REFERENCE
1. SciSpar announced positive interim results meeting primary endpoints at phase 2a study in Alzheimer’s disease patients with agitation. News release. SciSparc. November 7, 2022. November 7, 2022. https://www.globenewswire.com/news-release/2022/11/07/2549772/0/en/SciSparc-Announced-Positive-Interim-Results-Meeting-Primary-Endpoints-at-Phase-IIa-Study-in-Alzheimer-s-Disease-Patients-with-Agitation.html
2. SciSparc announces expanding its clinical operations to include a US site towards its phase 2b trial with its proprietary SCI-110 for the treatment of Tourette Syndrome. News release, SciSparc. July 8, 2022. Accessed November 7, 2022. https://www.biospace.com/article/releases/scisparc-announces-expanding-its-clinical-operations-to-include-a-u-s-site-towards-its-phase-iib-trial-with-its-proprietary-sci-110-for-the-treatment-of-tourette-syndrome/