The new phase 2b trial expands on successful phase 2a findings, in which treatment with SCI-110 resulted in a 21% reduction in tics across a cohort of adults with Tourette syndrome.
SciSparc, a pharmaceutical company in development of central nervous system therapies, has begun the process of submitting an investigational new drug application (IND) for a phase 2b trial to evaluate their cannabis-derived agent SCI-110 in patients with Tourette Syndrome (TS). As part of the submission, the company is looking to expand the trial and include a site in the US.1
The newly announced phase 2b trial stems from results of a previously conducted phase 2a trial, which showed that treatment using SCI-110 led to a 21% reduction of tic symptoms across a sample of patients with medically refractory TS. Additionally, the agent was proven to be safe, with no concerning AEs, and improved patients’ tic symptoms over time on the Yale Global Tic Severity Scale.1
The news stems weeks after the company announced that it successfully completed the development of the formulation to be used in the multinational phase 2b study,2 along with news from January 2022 that they entered agreements to test the drug at 2 clinical trial sites in Hannover, Germany, and Tel-Aviv, Israel.3 SCI-110, currently in development for other indications, such as obstructive sleep apnea and Alzheimer disease (AD) agitation, contains a combination of dronabinol, an FDA-approved synthetic form of tetrahydrocannabinol (THC), with endocannabinoid palmitoylethanolamide (PEA).
The new multinational, double-blind, placebo-controlled crossover trial will evaluate the safety, efficacy, and tolerability of the agent in a cohort of adults aged 18 to 65 years with TS. Patients will be randomly assigned 1:1 to either study drug or placebo and evaluated on tic severity change at end points of week 12 and week 26 using commonly frequented measures. Additionally, the primary safety objective of the trial will be to assess absolute and relative frequencies of serious adverse events (AEs) for the entire population and separately for the SCI-110 and placebo groups.1
"We are very excited about expanding our clinical sites to the US, especially after positive results obtained in a clinical trial led by professor Bloch MD, MS, an associate Professor in the Child Trial Center at Yale University, using our proprietary drug candidate," Adi Zuloff-Shani, chief technologies officer, SciSparc, said in a statement.1 "Expanding this trial, is part of our overall efforts to expedite the development of SCI-110 for TS, which is a greatly underserved therapeutic area. We believe our approach has significant advantages over available treatments and it is our intention to do everything in our ability to accelerate our trial in order to reach patients who are in need for effective treatment."
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TS is a neurological disorder characterized by involuntary movements and vocalizations called tics and is estimated to affect approximately 1% of the world’s population. There remains an unmet need for medications to treat patients with TS, as only 3 therapeutics—haloperidol (Haldol), pimozide (Orap), and aripiprazole (Abilify)—have been greenlit by the FDA. Physicians have also treated TS with off-label therapies such as guanfacine or clonidine, both of which are α-adrenergic agonists that are approved for use in the treatment of high blood pressure.
In January 2022, SciSparc announced they had recruited the first patient to participate in their phase 2a study to evaluate SCI-110 in patients with AD agitation, one of the more common neuropsychiatric symptoms patients face. The trial, titled "Clinical Study Protocol Phase II-a open label trial to evaluate the safety, tolerability and efficacy trend of SCI-110 in patients with Alzheimer Disease and agitation," will be conducted at the Sophie & Abraham Stuchynski Israeli Alzheimer's Medical Center, Ramat-Gan, Israel.4