Biopharmaceutical development company Neurotech International (ASX: NTI) has achieved a last patient-last visit (LPLV) milestone for its Phase I/II clinical trial of lead drug NTI164 in children diagnosed with paediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) and paediatric acute-onset neuropsychiatric syndrome (PANS).
A total of 15 patients have completed daily oral treatment over the initial 12 week period with all of them continuing to receive treatment under the extension phase (54 weeks) of the trial protocol.
Three of the patients have turned 18 years of age and continue to receive dosing under revised approval granted in May by the Human Research Ethics Committee.
Results of the trial are expected in September.
Efficacy and safety
Neurotech executive director Dr Thomas Duthy said the company was looking forward to reporting the efficacy and safety of NTI164.
“It is testament to the clinical interest in [this drug] 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,” he said.
“Neuroinflammation is well characterised in PANDAS/PANS, where approved drug therapies are lacking and clinical trials are desperately needed.”
Unique cannabis strain
NTI164 is a proprietary drug formulation derived from a unique cannabis strain with low tetrahydrocannabinol (THC) and a novel combination of cannabinoids.
It has been exclusively licenced for neurological applications globally.
Pre-clinical studies of NTI164 have demonstrated potent anti-proliferative, anti-oxidative, anti-inflammatory and neuro-protective effects in human neuronal and microglial cells.
The drug is being developed as a therapeutic product for a range of neurological disorders in children where neuroinflammation is involved.
Clinical diagnosis
PANDAS/PANS is a clinical diagnosis given to children who have a dramatic (typically within one day) onset of neuropsychiatric symptoms including obsessive-compulsive disorder and restrictive eating.
Symptoms can include repetitive tic movements, moodiness, aggression and anxiety.
The cause of PANS is unknown in the majority of cases however, the disorder is suspected to be triggered by infections, metabolic disturbances and other inflammatory reactions.
PANDAS is considered a subset of PANS.
