Neurotech International completes recruitment for PANDAS/PANS clinical trial

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By Lorna Nicholas - 
Neurotech International ASX NTI recruitment PANDAS PANS clinical trial paediatric autoimmune neuropsychiatric disorders associated with streptococcal infections NTI164

Neurotech International anticipates initial results from the trial in the third quarter of this year.


Neurotech International (ASX: NTI) has completed recruitment for a phase I/II trial assessing its lead candidate NTI164 in children with paediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) and paediatric acute-onset neuropsychiatric syndrome (PANS).

All-up, 15 paediatric patients with PANDAS/PANS have begun treatment with NTI164, which is a cannabinoid-based drug derived from a unique strain with low THC and is a novel combination of cannabinoids including CBDA, CBC, CBDP, CBDB and CBN.

Neurotech is advancing NTI164 as a therapeutic for a range of neurological disorders in children that involve neuroinflammation.

‘Desperate need’ for treatments

Commenting on the current study, Neurotech executive director Dr Thomas Duthy said neuroinflammation is “well characterised” in PANDAS/PANS.

He noted approved therapies for the disorders are lacking and “desperately needed”.

“We warmly congratulate the co-principal investigators Professor Russell Dale and Professor Michael Fahey and their respective clinical teams on the very rapid enrolment into this important clinical trial in PANDAS/PANS patients.”

“It is testament to the clinical interest in NTI164 as a treatment for certain paediatric neurological disorders characterised by persistent neuroinflammation and the evidence of benefit we have shown in our reported autism spectrum disorder trial,” Dr Duthy added.

Results in third quarter

Meanwhile, Prof Dale said he was “excited” to be involved in the PANDAS/PANS study, which will assess the safety and efficacy of daily oral treatment of NTI164 over 12 weeks.

“Our clinic has witnessed first-hand the devastating effects of this neurological disorder on patients and caregivers alike, and accordingly we believe the evidence supporting NTI164 in dampening neuroinflammation pathways in vitro, coupled with the safety and efficacy recently established in paediatric autism patients may translate to significant improvements in the clinical symptoms of PANDAS/PANS patients as part of this novel study.”

He added the company “eagerly awaited” the safety and efficacy data that the trial would generate, with results anticipated in the third quarter of this year.