Neurotech International Ltd Extends Rett Syndrome Study With Novel Cannabinoid Drug

Neurotech International Ltd (ASX: NTI) has extended a Phase I/II clinical trial evaluating the use of its proprietary cannabinoid drug in females with Rett Syndrome.

Rett Syndrome is an unmet medical indication that occurs almost exclusively in girls, with an incidence of one in 10,000 female live births.

The prevalence is around 15,000 girls and women in the U.S. and 350,000 globally.

Neurotech’s novel drug formulation, known as NTI164 used in the study is derived from a cannabis strain with low THC (M<0.3%) and a novel combination of cannabinoids including CBDA, CBC, CBDP, CBDB, and CBN.

NTI164 has been exclusively licenced for neurological applications globally.

Trial extension approval

This follows approval by Westmead’s Human Research Ethics Committee (HREC) under the clinical trial protocol.

All the 14 Rett Syndrome patients in the study will receive NTI164 for a total of 52 weeks.

Promisingly, all patients and their families at the Children’s Hospital at Westmead elected to continue treatment with the drug candidate.

Neurotech expects the results of the NTIRTT1 clinical trial in late Q1 to early Q2 CY2024.

NTI164 is being developed as a therapeutic drug product for a range of neurological disorders in children where neuroinflammation is involved.

Pre-clinical studies have demonstrated potent anti-proliferative, anti-oxidative, anti-inflammatory, and neuroprotective effects in human neuronal and microglial cells.

The market size is estimated at over US$2 billion annually.

Autism Spectrum Disorder

Neurotech completed a Phase I/II clinical trial in ASD, which demonstrated safety and efficacy endpoints at 28 days, 20 weeks, and 52 weeks of treatment with NTI164.

This rolled over into a Phase II/III randomised, double-blind, placebo-controlled clinical trial for the cohort with ASD.




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