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”), unveiled positive topline results from its investigator-initiated Phase IIa trial at the Sophie & Abraham Stuchynski Israeli Alzheimer’s Medical Center (IMCA). The trial results indicated that SciSparc’s proprietary SCI-110 provided a safe and effective solution for alleviating agitation in elderly Alzheimer's patients who participated.

Agitation is a devastating symptom of Alzheimer's Disease (AD), afflicting nearly all patients as the disease progresses, and imposing tremendous suffering and caregiving burdens. Existing treatments, including off-label medications, have questionable efficacy and come with notable side effects.

SciSparc’s open-label Phase IIa trial, conducted at IMCA, encompassed 18 AD patients grappling with agitation. It aimed to assess the safety, tolerability, and effectiveness of SCI-110, administered orally twice daily. The results not only met primary endpoints regarding tolerability and adverse events but also demonstrated SCI-110's potential to alleviate agitation without side effects.

Importantly, patients treated with SCI-110 were free of delirium, oversedation, hypotension, or falls, demonstrating its potential safety and suitability for elderly patients. Moreover, when measured by the Cohen Mansfield Agitation Inventory (CMAI), our treatment led to a significant 23% reduction in agitation symptoms. These results were further corroborated by the Edinburgh Feeding Evaluation in Dementia Scale, which showed a decline in eating and feeding difficulties.

“We are thrilled with these outcomes, as they signify a monumental potential in enhancing the lives of AD patients. Our commitment to pioneering innovative treatments with a global impact has never been clearer," said Dr. Adi Zuloff- Shani, Chief Technologies Officer of SciSparc.

The trial, titled "Phase IIa Open Label Trial to Evaluate the Safety, Tolerability and Efficacy Trend of SCI-110 in Patients with Alzheimer's Disease and Agitation," was conducted at IMCA under the guidance of Dr. Alexander Kaplan, MD, a board-certified geriatrician and principal investigator. This single-arm, open-label trial saw each subject receiving SCI-110 twice daily via oral administration, with follow-up for up to 39 days.

SCI-110 is a unique combination of FDA-Approved Dronabinol and the Company’s proprietary CannAmide™ formulation, creating a powerful solution for AD patients. SciSparc’s cannabinoid-centric approach enhances efficacy which allows lowering cannabinoid dose leading to a decrease in side effects compared to standalone cannabinoids.

AD is an urgent global health concern, and existing treatments fall short of meeting the needs of patients. SciSparc is committed to changing this reality and providing hope to millions worldwide.