New Drug Based On FDA-Approved Synthetic THC And CannAmide Shows Promise In Treating Agitation In Alzhemier's

SciSparc Ltd. SPRC, a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, announced positive topline results from its investigator-initiated phase IIa trial at the Sophie & Abraham Stuchynski Israeli Alzheimer’s Medical Center (“IMCA”), which suggest that the company’s proprietary SCI-110 is safe and tolerable while significantly improving agitation symptoms over time in elderly population with Alzheimer disease (“AD”) and agitation.

This phase IIa clinical trial was an open label trial, which included 18 patients diagnosed with AD and agitation, to evaluate the safety, tolerability, and efficacy trends of twice daily oral administration of SCI-110. Results showed that the trial met its primary endpoints of the number of drop-out subjects' due to poor tolerability and the number of trial treatment (SCI -110) related adverse events, with no SCI-110 related safety issues observed and no dropouts from the trial due to trial medication.

Specifically, SCI-110 did not cause delirium, oversedation, hypotension or falls. In addition, analysis of the trial results showed that the trial also met its secondary end point of change from baseline to end of treatment in agitation measured by the Cohen Mansfield Agitation Inventory (“CMAI”) where out of the fifteen patients treated with SCI-110 at least two consecutive times during the trial, thirteen of them at doses ranging between 7.5mg-12.5mg/day showed amelioration in agitation with no need to use rescue medication to control agitation. CMAI is a standard measure for measuring agitation in people with dementia. The trial showed that these subjects had amelioration in agitation. This resulted in an average reduction of 23% across the entire sample.

In the exploratory end points, a decrease in eating and feeding difficulties was shown in 11 patients out of the 15 patients treated at least two consecutive times during the trial as measured by the Edinburgh Feeding Evaluation in Dementia Scale, although the increase was not significant. No effect from the treatment was observed on cognitive measurements and sleep quality, as measured by the Mini Mental State Exam and by the and the Sleep Disorder Inventory, respectively.

In general, the trial medication was well tolerated with no negative response to the treatment observed throughout the trial duration.

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