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SciSparc Announces Successful Final Phase IIa Results, Meeting End Points of its Phase IIa Alzheimer Disease Patients with Agitation Trial
Topline results using the Company's SCI-110 met the trial’s primary and secondary end points, demonstrating high safety profile and reduced agitation
About this update from Scisparc Ltd.
[{"type":"text","content":"Topline results using the Company's SCI-110 met the trial’s primary and secondary end points, demonstrating high safety profile and reduced agitation\nTel-Aviv, June 02, 2023 (GLOBE NEWSWIRE) -- SciSparc Ltd. (NASDAQ: SPRC), a specialty, clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system (the “Company” or “SciSparc”), today 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. Agitation manifests over the course of AD’s progression in almost all affected patients, increasing patients’ suffering and burden of care. Current clinical practice is to treat with off-label drugs such as antipsychotics and benzodiazepines, whose efficacy is debatable, and which have frequent adverse effects. 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 (paired t-test: CMAI mean difference (mean +/- SD) =10.6+/-14.88, t= 2.76, df=1...