Neurotech International (ASX: $NTI) reports significant clinical benefits and safety in Phase I/II Rett Syndrome Clinical Trial

Neurotech International Limited (ASX: $NTI) has reported significant clinical benefits and safety results for 14 female paediatric patients who completed 12 weeks of daily oral treatment with NT1164 under the Company's Phase I/II clinical trial investigating the use of NT1164 in Rett Syndrome.

Executive Commentary on NTI164 Trial Results

Associate Professor Carolyn Ellaway, Principal Investigator of the NTIRTT1 Clinical Trial, Senior Staff Specialist, The Children's Hospital at Westmead, Sydney Children's Hospital Network, stated, 'The INTIRTTI clinical trial is the first time a broad-spectrum cannabinoid drug therapy (NTI164) has demonstrated significant patient improvements in Rett Syndrome using validated clinical measures including CGI-I and RSBQ. Our data is very encouraging as we have observed clinically meaningful improvements in those symptoms repeatedly deemed as most important for treating clinicians, caregivers and patients; notably communication, hand behaviours, anxiety/mood and quality of life. These benefits have not compromised patient safety, with NT1164 displaying an excellent safety profile over the 12 weeks of the trial.' Dr Thomas Duthy, Executive Director of Neurotech International, added, 'This fulsome data set reported today represents a very rapid translation of our strong conviction on the anti-neuroinflammatory and neuroprotective effects of NT1164 applied to a third paediatric neurological population, Rett Syndrome, where safe and effective therapies are urgently needed.'

Summary of NTI164 Trial Results

Neurotech International (ASX: $NTI) has reported significant clinical benefits and safety results for 14 female paediatric patients who completed 12 weeks of daily oral treatment with NT1164 under the Company's Phase I/II clinical trial investigating the use of NT1164 in Rett Syndrome. The trial demonstrated statistically significant and clinically meaningful benefits of NTI164 across multiple Rett-specific assessments, including primary and secondary endpoints. The results showed a 93% improvement in patients with 36% 'very much/much improved' in CGI-I, and a 205% improvement from week 4 to week 12 in the Rett Syndrome Behavioural Questionnaire (RSBQ). The trial also exhibited an excellent safety profile with minimal and manageable adverse events. Neurotech is considering a further registration-directed clinical trial and seeking further regulatory advice to accelerate the development of NT1164 for Rett Syndrome.