New Study Will Test Cannabinoid-based Therapy for Agitation

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by Margarida Maia |

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Cannabinoid-based therapy, agitation

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SciSparc is set to start a Phase 2a study evaluating the safety and efficacy of SCI-110, its investigational cannabinoid-based therapy for Alzheimer’s disease and agitation.

“We are very excited to begin our trial,” Adi Zuloff-Shani, PhD, chief technologies officer of SciSparc, said in a press release, noting that current off-label therapies for Alzheimer’s agitation have failed to provide relief for patients.

“We believe that this trial will corroborate our belief that SCI-110 may constitute a safe and effective treatment for agitation in Alzheimer’s disease,” Zuloff-Shani said.

A progressive neurodegenerative disorder, Alzheimer’s is best recognized by a loss of memory and a decline in cognitive function. However, people living with the disease also often experience neuropsychiatric symptoms such as a lack of interest in activities (apathy), a lack of social relationships (social withdrawal), a lack of ability to sleep (insomnia), and a feeling of restlessness or worry (agitation).

While agitation occurs in about half of patients, there are, as of yet, no approved therapies for treating such symptoms in people with Alzheimer’s.

“Right now, the most common medical treatment for agitation associated with Alzheimer’s is off-label use of antipsychotic drugs, which typically provide only marginal improvement, often with undesirable side effects,” Zuloff-Shani said.

Off-label use occurs when a healthcare provider prescribes a medication that is not approved to treat the the specific disease a patient has. This usually occurs when there are no approved medicines for that condition.

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SciSparc thinks a cannabinoid-based therapy could fill this unmet medical need.

SCI-110, formerly THX-110, combines two ingredients: dronabinol and palmitoylethanolamide. Dronabinol, a synthetic form of tetrahydrocannabinol (THC), the main active compound of cannabis, is approved by the U.S. Food and Drug Administration (FDA).

The second ingredient is CannAmide, the company’s oral tablet formulation of palmitoylethanolamide (PEA), a cannabinoid that is naturally produced by the body. It binds to the same receptors as compounds derived from cannabis.

Like other cannabinoids, the two ingredients of SCI-110 are expected to bind to receptors located along the central nervous system, comprised of the brain and spinal cord, and trigger a series of events.

“Cannabis products, in particular THC, might ameliorate the severity of some of the behavioral and psychological symptoms of dementia such as agitation and anxiety,” Zuloff-Shani said.

According to the company, SCI-110 is designed to inhibit the degradation of naturally produced cannabinoids while favoring the uptake of available dronabinol. The results of preclinical studies have shown that the SCI-110 combination is more efficient than dronabinol alone, thus enabling a lower dosage — which implies fewer side effects.

The Phase 2a study will evaluate SCI-110 for its safety and ability to control agitation and other behavioral disturbances in patients with Alzheimer’s.

It will take place at the Israeli Medical Center for Alzheimer’s, under the direction of Alona Raveh, MD, a board-certified geriatrician and the study’s principal investigator. SciSparc already has secured the approvals from the Israeli Ministry of Health and the Helsinki Committee that are needed to start the trial.

According to the company, SCI-110 is being developed under the FDA accelerated regulatory path of a 505 (b)(2) application to expand its portfolio of approved cannabinoids for a range of diseases, including Alzheimer’s.

Other indications for SCI-110, specifically Tourette syndrome and obstructive sleep apnea, also are  currently being investigated, the company said.