Neurotech International (ASX:NTI) has announced the commencement of a phase 1/2 open-label clinical study in 20 children aged between 5-17 years with Autism Spectrum Disorder (ASD).
The company said the study is being conducted under the guidance and supervision of Associate Professor Michael Fahey, the head of Paediatric Neurology Monash Children’s Hospital.
The company said this is the first time full-spectrum <0.3% THC medicinal cannabis strains will be assessed in ASD.
Neurotech said the study will assess FEN 164 in ASD over 16 weeks including a four-week washout period (no treatment). It said the study plan follows the successful completion of a series of successful in vitro studies.
Associate Professor Fahey said, “It is exciting to undertake a properly planned and executed study on a novel CBD product. Many other studies do not have the rigour to ensure that the results are translatable to evidence-based clinical treatments”.
The company said it has commenced discussions with the TGA and relevant regulatory agencies for the therapeutic expansion and registration of these novel full-spectrum plants.
The company said its Mente device will also be assessed in combination with its medicinal cannabis strains. “This is a very exciting and novel approach to the treatment of ASD for which there is the need for safe, effective therapies with no side effects that can improve a patient’s quality of life,” said Neurotech chair Brian Leedman. “Medicinal cannabis has the potential to provide this treatment, but only NTI/Dolce naturally derived strains offer full-spectrum CBDs with little to no THC, an important consideration when treating children.”