Tel Aviv, Israel, September 2, 2026
SciSparc Ltd. announced that its majority-owned subsidiary NeuroThera Labs Inc. is pursuing U.S. FDA Orphan Drug Designation for SCI-110, its investigational cannabinoid-based drug candidate for the treatment of adult Tourette Syndrome (TS). To support the regulatory pathway, NeuroThera has engaged RK Strategies, a U.S. government and public affairs consulting and lobbying firm focused primarily on healthcare issues. The engagement is intended to increase NeuroThera’s visibility among U.S. federal stakeholders and reinforce the clinical and public-health importance of developing new treatment options for adults with Tourette Syndrome.
SCI-110 Targets Unmet Need in Adult Tourette Syndrome
The potential FDA Orphan Drug Designation represents an important regulatory and commercial milestone for NeuroThera as it advances SCI-110 for adult Tourette Syndrome, a rare condition that may qualify for orphan-drug status. The FDA designation is generally available to investigational therapies targeting rare diseases or conditions affecting fewer than 200,000 people in the United States. If granted, orphan designation could provide SCI-110 with additional regulatory and commercial advantages as the company progresses its development strategy. NeuroThera is seeking to position SCI-110 as a differentiated treatment option in a disease area where patients continue to face limited treatment choices.
NeuroThera Advances Phase IIb Clinical Development of SCI-110
SCI-110 is a proprietary cannabinoid-based therapeutic candidate formulated to combine dronabinol and palmitoylethanolamide (PEA) in a single oral dosage form. The candidate is being developed to address tic symptoms and associated comorbidities in adults with Tourette Syndrome while aiming to manage tolerability. NeuroThera has initiated a Phase IIb clinical program at three academic centers: the Yale Child Study Center in New Haven, Connecticut; Hannover Medical School in Germany; and Tel Aviv Sourasky Medical Center in Israel. The Phase IIb program follows Phase IIa results in which SCI-110 produced an average 21% reduction in tics, measured using the Yale Global Tic Severity Scale Total Tic Score.
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SciSparc Strengthens SCI-110 Regulatory and Commercial Pathway
The combination of an advancing Phase IIb clinical program, multinational clinical development and the pursuit of FDA Orphan Drug Designation represents a significant step in NeuroThera’s development strategy for SCI-110. The engagement with RK Strategies is focused on strengthening the company’s presence among U.S. policymakers and healthcare stakeholders while supporting the broader regulatory and market-access strategy for a potential adult Tourette Syndrome treatment. SciSparc and NeuroThera are also developing additional cannabinoid-based programs targeting central nervous system disorders, including Alzheimer’s disease, agitation, autism spectrum disorder and status epilepticus. For SCI-110, upcoming clinical and regulatory milestones will remain important catalysts as NeuroThera works toward potential future commercialization.
Source: SciSparc, press relese
