Neurotech’s NTI164 Clears Key Safety Hurdle in 28-Day Toxicology Trials
Neurotech International has reported excellent safety and tolerability for its lead drug NTI164 in 28-day GLP toxicology studies, paving the way for regulatory submissions and longer-term clinical development.
- NTI164 showed no adverse effects in 28-day repeat-dose studies in rats and dogs
- Studies conducted under GLP and ICH guidelines to support FDA, TGA, and EMA filings
- No systemic or organ-specific toxicities observed, with all incidental findings resolving post-recovery
- Results underpin progression to longer-term toxicology studies and clinical trials
- Supports Neurotech’s focus on paediatric neurological disorders and chronic-use indications
Robust Safety Data Advances NTI164 Development
Neurotech International Ltd (ASX: NTI) has announced promising results from its 28-day Good Laboratory Practice (GLP) repeat-dose toxicology studies of NTI164, its proprietary cannabinoid-based drug formulation targeting paediatric neurological disorders. Conducted in both Sprague-Dawley rats and Beagle dogs, the studies demonstrated excellent tolerability with no safety concerns, marking a significant milestone in the drug’s clinical development pathway.
The studies adhered to stringent International Council for Harmonisation (ICH) guidelines, administering twice-daily oral doses across multiple levels followed by a 14-day recovery period. Across clinical observations, ophthalmic exams, neurological assessments, and clinical pathology, no test article-related adverse effects were detected. Importantly, any incidental observations resolved during recovery, underscoring a strong therapeutic margin for NTI164.
Strategic Regulatory Implications
These toxicology results establish the nonclinical safety foundation required for Investigational New Drug (IND) submissions and support regulatory filings with major authorities including the US Food and Drug Administration (FDA), Australia’s Therapeutic Goods Administration (TGA), and the European Medicines Agency (EMA). The use of two regulatory-relevant species and GLP compliance ensures broad acceptability across jurisdictions, positioning Neurotech well for global development.
Dr Anthony Filippis, CEO and Managing Director, highlighted the importance of these findings, noting that they significantly de-risk NTI164 for repeat-dose use in clinical trials. The data provide a solid platform for advancing into longer-term toxicology studies, a prerequisite for chronic-use indications, particularly in paediatric and neurological settings where Neurotech is focused.
Clinical and Commercial Outlook
NTI164 is a novel oral cannabinoid formulation derived from unique cannabis strains, containing a combination of cannabinoids such as CBDA, CBC, CBDP, CBDB, and CBN. It has demonstrated potent anti-proliferative, anti-oxidative, anti-inflammatory, and neuroprotective effects in preclinical models. Neurotech has already reported positive Phase II/III clinical trial results in Autism Spectrum Disorder (ASD), alongside encouraging data in Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS/PANS) and Rett Syndrome.
The successful toxicology studies reinforce NTI164’s safety profile and support Neurotech’s ambition to address unmet needs in paediatric neurological disorders with chronic neuroinflammation. The company is now poised to accelerate regulatory submissions and clinical development, while exploring commercial opportunities in a highly specialised and underserved market segment.
Looking ahead, Neurotech’s next steps will involve longer-term toxicology evaluations and continued engagement with regulatory bodies to secure approvals for expanded clinical trials. These developments will be closely watched by investors and industry observers eager to see how NTI164 progresses toward potential market entry.
Bottom Line?
NTI164’s strong safety profile clears a critical hurdle, setting the stage for accelerated clinical and regulatory progress.
Questions in the middle?
- When will Neurotech initiate the longer-term toxicology studies and what timelines are expected for completion?
- How will regulatory agencies respond to the safety data in upcoming IND submissions?
- What are the commercial plans and potential partnerships to support NTI164’s global rollout?
