SciSparc Ltd. (NASDAQ:SPRC), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system announced positive interim results from its Phase IIa trial of SCI-110 in patients with Alzheimer’s Disease (“AD”) and agitation.
“Agitation manifests in the course of AD progression in almost all affected patients, increasing patients’ suffering and burden of care,” reads a press release. “This Phase IIa clinical trial is an open-label study, which includes 20 patients diagnosed with AD and agitation, to evaluate the safety, tolerability, and efficacy trends of twice daily oral administration of SCI-110.”
Interim results summarize data from the first eight patients who completed the study, according to the press release.
The Interim Analysis
In the interim analysis, “the study met its primary endpoints of safety, including non-treatment related adverse events and dropout patients from the study; specifically, SCI-110 did not cause delirium, oversedation, hypotension, or falls even in the highest dose tested (12.5MG Dronabinol+400mg PEA).”
Interim Analysis Results
According to the researchers, the Interim Analysis showed that the study also met its secondary endpoint of Change from Baseline to end of treatment in agitation measured by the Cohen Mansfield Agitation Inventory (“CMAI”); out of the eight patients, six showed amelioration in agitation with no need to use rescue medication to control agitation.
The study, titled "Phase II-a Open Label Trial to Evaluate the Safety, Tolerability and Efficacy Trend of SCI-110 in Patients with Alzheimer's Disease and Agitation,” explained CMAI as a standard measure for measuring agitation in people with dementia. Conducted at the Israeli Medical Center for Alzheimer's under principal investigator Alexander Kaplan MD showed in the exploratory endpoints that appetite was increased in six out of the eight patients, as measured by the Edinburgh Feeding Evaluation in Dementia Scale.
“No effect was observed on cognitive measurements and sleep quality, as measured by the Mini-Mental State Exam, and by the Alzheimer's Disease Assessment Scale-cognitive subscale (for cognitive impairment assessments) and the Pittsburgh Sleep Quality Index (for quality of sleep assessment),” investigators said.
In general, the study medication was well tolerated with no negative response to the treatment observed during the duration of the study (32 days of treatments and seven days for follow-up after the study drug was stopped).
Adi Zuloff-Shani, Ph.D., Chief Technology Officer of SciSparc, said: “We are pleased that SCI-110 is showing clinically meaningful results and may provide a potential treatment option for Alzheimer’s patients with agitation (...) These results further support our efforts to reimagine medicine in this challenging area and reach this underserved patient population.”
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