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Neurotech’s NTI164 Shows Strong Long-Term Safety in Key Toxicology Study

Story Highlights
  • Neurotech’s lead cannabinoid therapy NTI164 showed strong long-term safety in a 90-day GLP non-rodent toxicity study.
  • These safety results support chronic dosing, bolster Neurotech’s regulatory package, and strengthen NTI164’s path toward registration.
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Neurotech’s NTI164 Shows Strong Long-Term Safety in Key Toxicology Study

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Neurotech International ( (AU:NTI) ) just unveiled an update.

Neurotech International has reported that its lead oral cannabinoid candidate NTI164 demonstrated a favourable long-term safety and tolerability profile in a 90-day GLP repeat-dose toxicity study in Beagle dogs, with no mortality, dose-limiting toxicities, or clinically meaningful adverse effects on key health markers. The study, conducted under US FDA GLP standards and enhanced with additional CNS-focused brain assessments following FDA guidance, supports the potential for chronic dosing, reinforces the company’s regulatory safety package for IND and TGA submissions, and underpins the continued clinical development of NTI164 for chronic treatment of paediatric neurological and neurodevelopmental disorders.

Neurotech said NTI164 was well tolerated at doses up to 216 mg/kg/day, around ten times the highest human dose tested, with any treatment-related findings at higher doses described as mild and reversible after a 14-day recovery period. All animals completed the dosing schedule without early terminations or progressive, irreversible, or life-threatening toxicities, a result the company views as a key milestone that strengthens its position as it advances NTI164 through registration pathways in major markets and seeks to establish the drug as a long-term therapy option in its target indications.

The most recent analyst rating on (AU:NTI) stock is a Sell with a A$0.01 price target. To see the full list of analyst forecasts on Neurotech International stock, see the AU:NTI Stock Forecast page.

More about Neurotech International

Neurotech International is a clinical-stage biopharmaceutical company focused on paediatric neurological and neurodevelopmental disorders, developing its broad-spectrum oral cannabinoid therapy NTI164. The company has reported clinically meaningful and statistically significant results in multiple Phase I/II and Phase II/III trials in Autism Spectrum Disorder and related paediatric neuropsychiatric conditions, and is progressing to a Phase III study in ASD.

Average Trading Volume: 1,247,201

Technical Sentiment Signal: Sell

Current Market Cap: A$16.85M

See more insights into NTI stock on TipRanks’ Stock Analysis page.

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