Positive Phase 2 Results Of SciSparc's Cannabinoid-Based Drug Candidate May Offer Some New Hope To Tourette Syndrome Patients

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Once thought to be a condition that improves with age, new research reveals that the tics — the sudden and involuntary twitches, movements, or noises — that characterize Tourette syndrome (TS) can continue well into adulthood. 

Though still rare — with estimates of about 118 cases per 1 million adults — TS can be both embarrassing and painful and there is no cure. With treatment options few and far between, most drugs given to patients with TS are not approved by the Food and Drug Administration (FDA) as a TS treatment. 

It’s this challenging reality that SciSparc Ltd. SPRC says it is trying to change with SCI-110, its cannabinoid-based drug candidate now being studied as a treatment for TS. With Phase 2a trials already underway, the pharmaceutical company states that it is working tirelessly to bring this urgently needed treatment to market as fast as possible.

Do Patients With Tourette Syndrome Lack Meaningful Treatment Options?

Living with TS has been likened to having hiccups, except more frequent and more disruptive to daily life. Like hiccups, the motor or vocal tics a person with TS has happen involuntarily and can take enormous effort to stop. Sometimes, no amount of effort is enough to stop the tic from happening. 

Though not life-threatening, these tics can be embarrassing if the movement or noise happens in social situations or in the workplace. They can also be painful, such as when the tic involves self-harm like punching or slapping. 

The medications most commonly prescribed — none of which are actually FDA-approved for TS — include:

• Alpha-adrenergic agonists like clonidine and guanfacine, originally meant for hypertension
• Stimulants like methylphenidate or dextroamphetamine, originally meant for attention deficit and hyperactivity disorder (ADHD)
• Serotonin reuptake inhibitors (SSRIs) like fluoxetine or paroxetine, originally meant for depression or anxiety-related disorders.

Of those, the most effective at reducing tics are dopamine receptor blockers, particularly pimozide, developed by Johnson & Johnson JNJ subsidiary Janssen Pharmaceuticals. However, common side effects include difficulty speaking, dizziness, fainting, loss of balance, behavioral changes and other debilitating reactions.

These troubling side effects are even more frustrating when you consider that, while effective, these dopamine receptor blockers don’t fully eliminate tics but just make them less frequent. 

As a result, doctors sometimes opt for alpha-adrenergic agonists like guanfacine, sold as Tenex by Promius Pharma LLC, a subsidiary of Dr. Reddy’s Laboratories Ltd. RDY. These hypertension medications reportedly don’t reduce tics as much as the dopamine blockers but the side effects — which usually include fatigue and sleep disturbance — are much milder, making them easier to tolerate.

Positive Phase 2A Results of SCI-110 Might Offer Promise For TS Patients

SciSparc, a clinical-stage pharmaceutical company developing a portfolio of cannabinoid-based treatments for difficult-to-treat conditions like TS, has created a compound using Dronabinol, an FDA-approved synthetic form of THC, and endocannabinoid palmitoylethanolamide (PEA) that has demonstrated the ability to reduce tics. 

The company reports that the compound may work by stimulating the cannabinoid receptors in a patient’s central nervous system to help modulate dopamine neurotransmission. Like dopamine receptor blockers, SCI-110 potentially targets the abnormal dopamine systems thought to play a role in TS. 

Unlike dopamine receptor blockers, it may offer these benefits without causing speech and movement difficulties or any of the other severe side effects. The improved safety profile means SCI-110 could finally offer the tic reduction TS patients need without the adverse reactions that make existing treatment options sometimes difficult to stick with for the long term.

The results of the Phase 2A trial of SCI-110 as a TS treatment were published in the Journal of Neuropsychiatry and Clinical Neurosciences last year. Patients receiving SciSparc’s drug candidate saw a 21% reduction in tics on average, with about 40% of patients seeing a tic reduction above 25%. With minimal adverse reactions, patients were reportedly able to enjoy these improvements in their symptoms without any serious side effects.

Based on those results, SciSparc has a Phase 2B clinical trial slated for this year. The randomized, double-blind, placebo-controlled crossover study will further examine the safety and efficacy of SCI-110 as a treatment for TS. The hope is that the Phase 2B results will bolster the data from the Phase 2A trial, helping move the drug candidate closer to approval by the Food and Drug Administration. 

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