- Neurotech International (NTI) is granted approval to begin phase one and two paediatric clinical trials
- The company received written approval from the Human Research Ethics Committee (HREC), along with clinical trial notification scheme clearance by the Therapeutic Goods Administration (TGA)
- Neurotech’s clinical trials will assess its leading treatment, NTI164, in children with paediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) and paediatric acute-onset neuropsychiatric syndrome (PANS)
- The company’s recruitment of 15 patients will commence in Q1 CY2023, with trial results expected in 2H CY2023
- NTI shares were last trading at 7.1 cents at 2:00 pm AEDT
Neurotech International (NTI) has been given the green light to launch its phase one and two paediatric clinical trials in Australia.
The company confirmed it received written approval from the Human Research Ethics Committee (HREC) to commence its phase one and two clinical trials of leading treatment NTI164 in children diagnosed with paediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) and paediatric acute-onset neuropsychiatric syndrome (PANS).
Neurotech also received clinical trial notification scheme clearance from the Therapeutic Goods Administration (TGA).
Neurotech Executive Director Dr Thomas Duffy commented the trial was the first of its kind.
“To our knowledge, this is the first clinical trial conducted in PANDAS/PANS patients with a novel oral full-spectrum cannabinoid drug formulation (NTI164), which seeks to provide initial evidence of clinical efficacy and safety in these patients over the 12 week study period, with all patients eligible to continue to receive our treatment for up to 54 weeks,” he said.
“Given the urgent unmet medical need and lack of safe and effective approved therapies, the company intends to rapidly progress development of NTI164 in PANDAS/PANS by leveraging available regulatory mechanisms, including orphan drug designations where applicable.”
NTI164 is the company’s leading treatment, a proprietary drug formulation stemming from a unique cannabis strain with low THC, and a combination of cannabinoids.
The company reported a “very acceptable” safety and toxicity profile was revealed after 20 weeks of treatment with NTI164 for children with autism spectrum disorder (ASD) in its phase one and two trials.
The paediatric trials will take place at two sites, the Children’s Hospital at Westmead in New South Wales and the Paediatric Neurology Unit at Monash Medical Centre in Victoria.
The company confirmed the recruitment of 15 patients for its phase one and two clinical trials will commence in Q1 CY2023, with trial results expected in 2H CY2023.
NTI shares were last trading at 7.1 cents at 2:00 pm AEDT.