Clinical-stage biopharmaceutical development company Neurotech International (ASX: NTI) has received the green light to commence a trial of its NTI164 drug formulation on paediatric patients with Spastic Diplegia Cerebral Palsy (Spastic CP).
The human research ethics committee (HREC) approval and clinical trial notification (CTN) scheme clearance by the Therapeutic Goods Administration (TGA), provides the go-ahead for a Phase I/II clinical trial will investigate the use of NTI164 on patients diagnosed with Spastic CP) the most common form of CP.
Spastic CP 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. In Australia, there are approximately 34,000 persons living with CP. The market is estimated to grow to around $6.5 billion annually by 2030.
Neurotech’s NTI164 proprietary drug formulation is derived from a unique cannabis strain with low tetrahydrocannabinol (THC) 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. The non-ambulant Spastic CP patients will have a clinical diagnosis of gross motor function classification system (GMFCS) severity of 2-3 and the trial will determine the efficacy and safety of NTI164 in these patients from baseline to 12 weeks of treatment with NTI164.
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 Phase II/III clinical trials in autism.
“We are pleased to have received HREC clearance for this important clinical trial of NTI164 in children with spastic CP. 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,” Dr Thomas Duthy, executive director of Neurotech International, said.
“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.” “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.