Phase IIa trial outcome indicates the potential for a new way to help Alzheimer’s patients’ agitation
Tel-Aviv, Nov. 15, 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”), 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.
About SciSparc Ltd. (NASDAQ: SPRC)
SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive cannabidiol (CBD): SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer's disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of autism spectrum disorder and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focusses on the sale of hemp-based products on the Amazon.com marketplace.
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses: the potential safety, efficacy, advantages and benefits of SCI-110 in the elderly population with AD and agitation; and SciSparc’s efforts to develop proprietary innovative treatments with the ability to change millions of lives worldwide. Because such statements deal with future events and are based on SciSparc's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in SciSparc's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on May 1, 2023, and in subsequent filings with the SEC. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.