Biopharmaceutical development company Neurotech International (ASX: NTI) has received Human Research Ethics Committee (HREC) approval to extend the current Phase II/III clinical trial in Autism Spectrum Disorder (ASD) patients.
The extension will allow for patients who turn 18 years of age to remain on treatment with NTI164 during the extension phase of the trial for up to 54 weeks of total treatment. The current HREC approval covers treatment with NTI164 in a paediatric population of ASD.
We are pleased to secure this additional HREC approval for NTI164 in this patient population,” Dr Thomas Duthy, Executive Director of Neurotech International, said.
“I am delighted with the progress of this large double-blind, placebo controlled clinical trial and we remain steadfastly committed to developing NTI164 as a first-line treatment for Level 2-3 patients with autism where the market need for new therapies remains significant.
“Importantly, with recruitment into the trial to complete during the current quarter, we are on track to report results during the first quarter of calendar year 2024 (Q3 FY24).”
Neurotech has completed a Phase I/II clinical trial in Autism Spectrum Disorder (ASD), which demonstrated excellent safety and efficacy results at 28 days, 20 weeks and 52 weeks of treatment with NTI164.
The company has commenced a Phase II/III randomised, double-blind, placebo-controlled clinical trial in ASD and additional Phase I/II trials in Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS), collectively PANDAS/PANS, along with Rett Syndrome during CY2023. Neurotech is also commercialising Mente, the world’s first home therapy that is clinically proven to increase engagement and improve relaxation in autistic children with elevated Delta band brain activity.