NeuroThera Labs opens Yale site for Phase IIb Tourette trial
NeuroThera Labs, a majority-owned subsidiary of Nasdaq-listed SciSparc, has activated a clinical trial site at the Yale Child Study Center as part of its ongoing Phase IIb study of SCI-110, a cannabinoid-based candidate for Tourette Syndrome in adults. The Yale site joins existing sites at Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel, giving the programme a three-country footprint.
SCI-110 combines dronabinol, a synthetic form of THC, with palmitoylethanolamide, an endocannabinoid-like fatty acid amide, in a single oral formulation. The rationale is that combining a partial CB1 agonist with an agent that modulates endocannabinoid tone may reduce tic frequency and severity while limiting the psychoactive side effects typically associated with cannabinoid-based medicines.
Trial design and prior data
The Phase IIb study is a randomised, double-blind, placebo-controlled crossover trial enrolling adults aged 18 to 65. Participants will receive either SCI-110 or placebo, and the primary efficacy endpoint is the change in tic severity as measured by the Yale Global Tic Severity Scale Total Tic Score at weeks 12 and 26 relative to baseline. Safety will be tracked through adverse event monitoring throughout the study period.
The Phase IIb design builds on Phase IIa results that showed an average tic reduction of 21% across all participants on the same severity scale. That figure relates to the full study population rather than a responder subgroup, which provides a more conservative read on the potential effect size. The company has not published the Phase IIa data in a peer-reviewed journal, and full details of confidence intervals, safety signals, and responder rates remain pending.
Dr Adi Zuloff-Shani, Chief Technology Officer of NeuroThera, described the Yale activation as a "significant milestone" in the global development programme, adding that Tourette Syndrome in adults represents a major unmet need with "limited therapeutic options" for patients experiencing persistent and severe symptoms.
Market context and competitive landscape
Tourette Syndrome affects an estimated one in 160 school-age children, with a meaningful proportion carrying symptoms into adulthood. The current approved pharmacological options are limited: the FDA has approved two vesicular monoamine transporter 2 inhibitors, valbenazine and deutetrabenazine, for TS-associated tics in adults, and older off-label agents such as antipsychotics remain widely used despite tolerability concerns. Behavioural interventions, notably Comprehensive Behavioural Intervention for Tics, are recommended as first-line treatment in many guidelines, but access remains patchy.
The cannabinoid angle in TS is not new. Small investigator-led studies in Europe, including work published from the Hannover group, have explored THC-based preparations in TS for more than two decades. What SCI-110 attempts to add is a proprietary fixed-dose combination and a formally powered Phase IIb readout, which, if positive, could support a regulatory filing. The involvement of the Yale Child Study Center, which hosts one of the leading tic-disorder research programmes in the United States, lends the trial credibility and may facilitate recruitment of well-characterised adult patients.
SciSparc's broader pipeline also includes cannabinoid programmes in Alzheimer's-related agitation and autism spectrum disorder, meaning corporate resources are spread across several indications. Investors will be watching whether NeuroThera can secure a Phase IIb readout without requiring additional financing, given that SciSparc has not disclosed a current cash runway figure in this announcement. A successful topline result would likely be the catalyst needed to attract a larger development or licensing partner for the TS indication.