- Neurotech International (NTI) reports 93 per cent of patients showed symptom improvements in a recent trial of its NTI64 drug designed to treat children with ASD
- Under the trial, 14 patients aged eight to 17 received varying doses of NTI164 twice a day over 28 days, with 13 showing symptom improvement by the end of the trial
- Further, Neurotech says it found all doses of the medicinal cannabis drug administered as part of the trial were safe and well-tolerated in patients
- The company now plans to extend the trial and launch another phase to further assess the long-term safety and efficacy of the drug, potentially leading to drug registration
- Shares in Neurotech International are up 5.33 per cent to 7.9 cents per share at midday AEST
Neurotech International (NTI) has reported that 93 per cent of patients showed symptom improvements in a recent trial of its NTI64 drug designed to treat children with autism spectrum disorder (ASD).
The phase I/II trial was designed to test the safety of the medicinal cannabis drug, with 14 patients aged between eight and 17 receiving varying doses of NTI64 twice a day over 28 days. Neurotech said 13 of these patients showed symptom improvements by the end of the trial.
Further, parental and carer observations also indicated consistent improvement in the trial participants’ “overall functioning” when compared to baseline at the commencement of the trial.
Meanwhile, the company said all doses of NTI64 administered as part of the trial were safe and well-tolerated in patients.
Neurotech International Chairman Brian Leedman said the company could not “underestimate” the significance of these results, calling the trial a “world-first” landmark.
“NTI is now a significant step closer in the drug development timeline to introducing to the market a treatment option for paediatric ASD,” Mr Leedman said.
“The fact that the results are based on a 28 day trial period with further significant results from patients who have remained on the treatment, the company is very excited that is genuinely opening up a new treatment pathway for not just ASD, but a wide range of neurological disorders.”
The company also reported that its patent strategy was on track and, if granted, its patents could add significant commercial value to the future commercialisation of NTI164 across ASD and other neurological disorders.
Neurotech has initiated discussions with the TGA to assess product scheduling and classification for the Australian Market.
In collaboration with regulatory experts, the company is now mapping out a full regulatory development roadmap for the registration and commercialisation of NTI164.
Neurotech said NTI164, one of its proprietary cannabis strains, was the world’s first full-spectrum medicinal cannabis product to be successfully studied in children with ASD.
Shares in Neurotech International are up 5.33 per cent to 7.9 cents per share at midday AEST.