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 obtained the required batch release certification from a European Qualified Person, according to a company announcement distributed via NEWMEDIAWIRE. The certification is a regulatory milestone that authorizes shipment of clinical trial material to participating study sites and supports the initiation of patient enrollment in the company's FDA-approved Phase IIb clinical trial for Tourette Syndrome in adults.
The 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 completed 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 operational milestone matters because Tourette Syndrome represents a condition with substantial unmet treatment needs. The Phase IIb study is designed to evaluate the efficacy, safety and tolerability of SCI-110, NeuroThera's proprietary, patent-protected cannabinoid-based drug candidate that combines dronabinol and palmitoylethanolamide (PEA) in a single oral dosage form. If the trial progresses successfully, it could offer a new treatment option for adults living with the neurological disorder.
For investors, the completion of manufacturing and the European Qualified Person release reduce a key operational risk in the clinical timeline. The company is now advancing toward patient enrollment, and the shipment of investigational product to the three sites is the next tangible step. NeuroThera is a subsidiary of SciSparc Ltd., and its shares trade on the TSX Venture Exchange under the symbol NTLX.
Additional details about the company's disclosures and risk factors are available in its continuous disclosure documents filed on www.sedarplus.ca. The original release can be viewed at www.newmediawire.com.
