NeuroThera Labs Inc. (TSXV: NTLX), a clinical-stage pharmaceutical company and subsidiary of SciSparc Ltd., has completed manufacturing of its investigational product SCI-110 and secured the required batch release certification from a European Qualified Person, according to a company announcement issued via NEWMEDIAWIRE. The certification is a regulatory prerequisite that authorizes shipment of clinical trial material to participating study sites and represents a critical operational milestone for the company’s FDA-approved Phase IIb clinical trial evaluating SCI-110 for the treatment of Tourette Syndrome in adults.
The release enables site activation activities and supports the initiation of patient enrollment. The Phase IIb trial is being conducted at three clinical sites: Yale Child Study Center at Yale School of Medicine in New Haven, Connecticut; Hannover Medical School in Hanover, Germany; and Tel Aviv Sourasky Medical Center in Tel Aviv, Israel. All participating sites have successfully completed their site initiation activities and are prepared to receive clinical trial drug supplies following the Qualified Person batch release. Investigational product shipments to study sites are expected in the near term, the company said.
SCI-110 is NeuroThera’s proprietary, patent-protected cannabinoid-based drug candidate that combines dronabinol and palmitoylethanolamide (PEA) in a single oral dosage form. The Phase IIb study is designed to evaluate the efficacy, safety and tolerability of SCI-110 in adults with Tourette Syndrome, a condition characterized by substantial unmet treatment needs. The completion of manufacturing and batch release, together with the readiness of all three clinical sites, positions the company to advance toward patient enrollment.
The news matters for several reasons. Tourette Syndrome affects both children and adults, and treatment options remain limited, particularly for adults who do not respond adequately to existing therapies. A new cannabinoid-based oral candidate could offer an alternative mechanism of action if clinical trials confirm its benefits. For NeuroThera, a successful Phase IIb trial would represent a significant value inflection point and could attract partnership or licensing interest from larger pharmaceutical companies focused on central nervous system disorders.
For investors, the announcement reduces near-term execution risk by confirming that clinical supply logistics and regulatory batch release requirements have been satisfied. The company’s shares trade on the TSX Venture Exchange under the ticker NTLX, and further details on the trial and corporate disclosures are available through the company’s filings on www.sedarplus.ca. The original release can be viewed at www.newmediawire.com.
NeuroThera Labs is a clinical-stage pharmaceutical company focused on developing novel therapeutics for central nervous system disorders and other underserved health conditions through collaborations and innovative combinations. The company cautions that forward-looking statements regarding patient enrollment timing, product shipments, and the potential efficacy, safety and tolerability of SCI-110 are subject to known and unknown risks and uncertainties that could cause actual results to differ materially.
