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Neurotech International receives approval to extend NTI164 clinical trial for treatment of PANDAS and PANS

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By Imelda Cotton - 
Neurotech International ASX NTI extend NTI164 clinical trial treatment PANDAS PANS Human Research Ethics Committee HREC
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Clinical-stage biopharmaceutical development company Neurotech International (ASX: NTI) has received Human Research Ethics Committee (HREC) approval to extend a current Phase I/II clinical trial of lead drug NTI164 for the treatment of paediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) and paediatric acute-onset neuropsychiatric syndrome (PANS).

The approval will allow participants to continue receiving treatment up to 20 years of age.

Neurotech completed the recruitment of 15 paediatric patients earlier this month, with clinical results expected later this year.

Milestone development

Executive director Dr Thomas Duthy said HREC approval was a milestone development for the company.

“This gives us the utmost flexibility to treat PANDAS and PANS patients if they elect to continue daily oral NTI164 dosing beyond their 12-week treatment phase and into the 54-week extension phase of the trial,” he said.

“Our study investigators and parents requested the protocol change to allow a patient who turns 18 years of age while on treatment to remain compliant with the approved study protocol.”

Previous HREC approval received in January allowed patients up to 17 years of age to participate in the trial.

Treatable conditions

PANDAS and PANS are little-known but treatable medical conditions which present as psychiatric disorders and are estimated to affect 1 in every 200 children.

Patients can experience a sudden and dramatic change in personality, independence and ability to participate in typical childhood activities.

Symptoms can include anxiety, obsessive compulsive disorder, irritability, developmental regression, sleep disturbance and a refusal to attend school or a deterioration in school performance.

Motor skills and nutritional intake can also be affected.

Cannabinoid-based drug

Neurotech’s NTI164 is a cannabinoid-based drug derived from a unique strain with low THC (tetrahydrocannabinol) and is a novel combination of cannabinoids including cannabidiolic acid (CBDA), cannabichromene (CBC), cannabidiphorol (CBDP), cannabidibutol (CBDB) and cannabinol (CBN).

The company is advancing NTI164 as a therapeutic for a range of paediatric neurological disorders such as PANDA and PANS which involve neuroinflammation.

Dr Duthy said approved therapies for the disorders are lacking and “desperately needed”.