Neurotech International receives $3.17 million R&D tax incentive refund for treatment of paediatric neurological disorders

Clinical-stage biopharmaceutical development company Neurotech International (ASX: NTI) has been recognised for its breakthrough development in the proposed treatment of paediatric neurological disorders with the grant of a $3.17 million research and development (R&D) tax incentive refund.

Covered under the Australian government’s R&D tax incentive scheme, the refund relates to eligible activities for the financial year ended 30 June 2023.

Executive director Dr Thomas Duthy said the tax incentive helps companies like Neurotech innovate and grow by offsetting some of the costs of eligible R&D.

Rapidly developing growth strategy

He said the R&D incentive payment comes at a time when Neurotech is moving rapidly along its growth strategy and treatment development path.

Most recently the company has been undertaking clinical trials in autism, Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS), as well as Rett Syndrome.

All commenced within the last 12 months, with the latest PANDAS/PANS trials delivering significant clinical effects in patients.

“The receipt of the R&D refund takes our 30 September 2023 pro-forma cash balance to $6.1 million, which is sufficient to fund the company’s operations through FY24 and complete all active clinical trials across three paediatric neurological disorders,” Dr Duthy said.

Breakthrough PANDAS/PANS trials

In what has been described as a world first, Neurotech successfully demonstrated that its lead biopharmaceutical product NTI164 was able to reduce and alleviate some of the main symptoms of PANDAS/PANS.

The company received strong clinical results from a 15 patient, open-label Phase I/II clinical trial of NTI164 in children diagnosed with PANDAS and PANS.

There is currently no “approved” therapy or specific drug for the treatment of PANDAS/PANS, which are paediatric disorders characterised by sudden onset neuropsychiatric symptoms, often triggered by an infection.

These symptoms include obsessive-compulsive behaviours, anxiety, tics, mood disturbances, cognitive difficulties and other neurological symptoms.

Noticeable improvements identified

Neurotech’s trial identified that changes and improvements registered with participants in the trial were deemed to considerably improve their quality of life.

It was assessed that NTI164 successfully improved obsessive-compulsive disorder (OCD)-like behaviours, significantly reduced anxiety and improved emotional changes, leading to outstanding patient outcomes when compared to where they were at the start of the trial.

Dr Duthy said results of the trial were a significant milestone for the company.

Not only did the study re-validate the effectiveness of NTI164 in treating complex neuro-inflammatory disorders, it was also a huge step forward in the company’s human clinical program, with Neurotech being the only company in Australia that is carrying out a rigorous pharmaceutical development program using a biopharmaceutical – NTI164 – derived from low-THC medicinal cannabis.

The NTI164 treatment was also found to be well-tolerated by the patients involved in the trial with no serious adverse events recorded, with all 15 participants electing to remain on the therapy at the conclusion of the trial.

Short-term strategy

The company’s short-term strategy is to generate clinical evidence of safety and benefit for NTI164 across multiple paediatric neurological disorders to add substantial value to its NTI164 therapeutic platform.

In parallel, the company continues to pursue a strategy of establishing strategic partnerships aimed at progressing drug registrations in the US, Australia and Europe.

The company is preparing to apply for an orphan drug designation for NTI164 associated with the treatment of PANDAS/PANS in the US and EU.

Neurotech is also awaiting results from a Phase I/II clinical trial investigating the use of NTI164 in children with Rett Syndrome in Q1 2024.