Clinical-stage biopharmaceutical development Neurotech International (ASX: NTI) has obtained positive earl results in an open-label Phase I/II clinical trial of NTI164 in children diagnosed with PANDAS and PANS.
With all 15 patients entering into the 54 week extension phase of the trial in late August 2023, NTIPANS1 has showed a statistically significant and clinically meaningful improvement shown across a range of gold-standard, clinically validated assessments over 12 weeks of NTI164 treatment.
Data analysis undertaken at 24 weeks has shown continued improvements in patients with no adverse or serious adverse events recorded from 12-24 weeks.
NTIPANS1 was the first ever clinical trial to show highly significant clinical improvements in PANDAS/PANS patients (n=15) with a broad-spectrum cannabinoid drug therapy (NTI164) with excellent safety at 12 weeks.
"Following a minimum of 12 weeks of daily oral administration of NTI164, our patients diagnosed with PANDAS/PANS experienced notable enhancements in their clinical functionality, coupled with an absence of safety concerns,” Professor Russell Dale, Co-Principal investigator of the NTIPANS1 trial, said.
“Consequently, these patients opted to prolong their treatment into the extension phase of the trial for an additional year. This extension has afforded us the opportunity to delve deeper into both safety profiles and clinical outcomes beyond the initial study duration, revealing continued substantial clinical advantages compared to baseline, along with marked enhancements in anxiety, depression, and overall illness severity.
“Noteworthy improvements have also been observed in measures of tic severity and obsessive-compulsive behaviours, all of which exhibit statistical significance when juxtaposed with baseline data.
“These findings consistently bolster the case for the prolonged usage of NTI164 within this challenging-to-treat patient cohort, showcasing benefits across various critical and validated clinical metrics. We eagerly anticipate disseminating these pivotal scientific insights through publication in a leading medical journal."
PANDAS is Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections and PANS refers to Paediatric Acute-Onset Neuropsychiatric Syndrome.
Collectively 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 (OCD) and/or restrictive eating. Children may exhibit repetitive tic movements, become moody, irritable/aggressive and anxious and have difficulty with schoolwork.
