Neurotech International receives approval to extend trial to adult ASD patients

Go to Filip Karinja author's page
By Filip Karinja - 
Neurotech International ASX NTI approval extend trial adult ASD patients Autism Spectrum Disorder Human Research Ethics Committee HREC

Clinical-stage biopharmaceutical company Neurotech International (ASX: NTI) has been granted approval by the Human Research Ethics Committee (HREC) to extend their current Phase II/III clinical trial in Autism Spectrum Disorder (ASD) patients.

The extension allows patients who turn 18 years of age to continue receiving treatment with NTI164 during the extended phase of the trial for up to 54 weeks in total.

NTI164 is a treatment under development by Neurotech International targeting ASD, a range of conditions characterised by challenges with social skills, repetitive behaviours, speech and nonverbal communication.

The current HREC approval encompasses the treatment of NTI164 in a paediatric patients diagnosed with ASD.

“We are pleased to secure this additional HREC approval for NTI164 in this patient population. 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,” said Neurotech’s executive director Dr Thomas Duthy.

R&D refund and other trials

Neurotech last month received a $3.17 million research and development tax incentive refund under the Australian government’s scheme for its work in paediatric neurological disorders.

The funding boost coincides with the company’s progression in clinical trials for autism, Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS), Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS) and Rett Syndrome.

The company’s trials in PANDAS/PANS with its biopharmaceutical product NTI164 have shown significant clinical effects, with no approved therapy currently available for these disorders.

NTI164 has demonstrated improvements in obsessive-compulsive behaviours, anxiety and emotional changes in trial participants.

Neurotech’s short-term strategy focuses on generating clinical evidence for NTI164 across multiple paediatric neurological disorders and pursuing strategic partnerships for drug registrations in various regions, with results from its Rett Syndrome trial expected in Q1 2024.