Neurotech International accelerates specialist medical solutions for neurological disorders
Neurotech International (ASX: NTI) continues to make excellent progress in accelerating its specialist medical solutions for the treatment of neurological disorders.
The company is refining the use of its NTI164 treatment to help overcome a significant unmet medical need for new safe and effective therapies.
In its 2024 development plans, Neurotech is aiming to complete recruitment for a Phase II/III clinical trial for NTI164.
The company is also preparing for Human Research Ethics Committee (HREC) approval for a Phase I/II clinical trial in paediatric spastic cerebral palsy in the second quarter.
Towards the end of the year, Neurotech is expecting to obtain results of a Phase I/II Rett Syndrome clinical trial (Q3 FY24) and results of a Phase II/III ASD clinical trial (Q3 FY24).
Neurotech’s upcoming activities also include submitting an application for orphan drug designation (ODD) for NTI164 in PANDAS/PANS treatment with US and EU regulatory bodies.
Recent trial success
The future work will build on the successes the company achieved in the September quarter.
In late August, Neurotech confirmed that the last patient’s last visit (LPLV) program had successfully completed treatment for a NTI164 clinical trial in PANDAS/PANS.
All 15 patients completed 12 weeks of treatment under the trial protocol and elected to continue to receive daily oral treatment with NTI164.
Rett Syndrome trials
Prior to that, Neurotech received written Human Research Ethics Committee (HREC) approval and clinical trial notification (CTN) scheme clearance by the Therapeutic Goods Administration (TGA) to commence the Phase I/II clinical trial investigating the use of NTI164 in female Rett Syndrome patients.
In early August, Neurotech enrolled and treated its first patient under the company’s Phase I/II clinical trial and in late September, Neurotech announced the completion of patient recruitment of the trial which is investigating the use of NTI164 in female Rett Syndrome sufferers.
The NTIRTT1 Phase I/II clinical trial is examining the effects of daily oral treatment of NTI164 in 14 Rett Syndrome patients. It will be an open-label, exploratory study over 16 weeks of treatment with NTI164 at the maximum tolerated dose.
Promising early results
The company believes the early neuro-protection shown by NTI164 could translate to improved clinical outcomes in Rett Syndrome patients.
The results of the Phase I/II clinical trial are expected early in the first quarter of 2024.
Elsewhere, the company continues to recruit patients in the Phase II/III clinical trial, with a target recruitment level of 54 paediatric patients.
Neurotech is now looking towards developing an orphan drug pathway and will progress with applications for an orphan drug designation (ODD) for NTI164 associated with the treatment of PANDAS/PANS in the US and Europe.
Notably, the company remains fully funded to complete these current clinical trials through to top-line results.