Neurotech International receives HREC approval for cerebral palsy treatment trial

Clinical-stage biopharmaceutical development company Neurotech International (ASX: NTI) has received official approval to commence a trial of its unique NTI164 proprietary drug formulation on paediatric patients with spastic diplegia cerebral palsy (CP).

The human research ethics committee (HREC) approval and clinical trial notification scheme clearance by the Therapeutic Goods Administration provides the go-ahead for a phase I/II clinical trial that will investigate the use of NTI164 on patients diagnosed with spastic CP.

Spastic CP, the most common form of the condition, represents up to 80% of CP cases and is the leading cause of childhood disability.

Approximately 750,000 children and adults in the United States have CP, with approximately 34,000 cases in Australia.

The market is estimated to grow to around $6.5 billion annually by 2030.

Unique cannabis strain

Neurotech’s NTI164 is derived from a unique cannabis strain with low tetrahydrocannabinol and a novel combination of cannabinoids.

The phase I/II trial is designed to be a single-arm, open-label clinical trial that will recruit up to 14 paediatric patients.

Non-ambulant spastic CP patients with a clinical diagnosis of gross motor function classification system severity of 2-3 will be involved and the trial will determine the efficacy and safety of NTI164 in these patients from baseline to 12 weeks of treatment.

The trial intends to enrol patients at the Monash Medical Centre in Victoria under the guidance of lead investigator professor Michael Fahey, head of the paediatric neurology unit and director of neurogenetics at Monash.

Professor Fahey has significant experience with NTI164, having led both Neurotech’s phase I/II and II/III clinical trials in autism.

Neurotech International executive director Dr Thomas Duthy said the primary endpoint of the trial is the provision of information to the caregiver priorities and child health index of life with disabilities questionnaire, which evaluates caregivers’ perceptions of health-related quality of life and caregiver impact on children with CP.

The secondary endpoints will include safety and the effect of NTI164 on pain, sleep, seizure frequency, dystonia (involuntary muscle contraction) and spasticity.

HREC clearance crucial

“We are pleased to have received HREC clearance for this important clinical trial of NTI164 in children with spastic CP,” Dr Duthy said.

“Although there are a variety of drug therapies used in the treatment of spastic CP, they are often associated with sedation, confusion, memory loss and attention deficits.”

“For first-line treatment with oral baclofen the actual evidence of efficacy remains somewhat subjective and not necessarily supportive of widespread use in spastic CP,” he added.

“Accordingly, we see NTI164 as potentially a new breakthrough treatment as part of the clinical armamentarium to treat CP spasticity more effectively noting improvements in gross motor function, increased participation at a social level and comfort are considered important treatment goals to improve the overall quality of life of the individual.”

Neurotech is aiming to commence the phase I/II trial in 1H CY2024.