Ann: Phase II/III ASD Trial Successfully Meets Primary Endpoint, page-2

Neurotech Phase II/III Autism Trial Successfully Meets Primary Endpoint Highlights:

• NTIASD2 Phase II/III clinical trial met the primary endpoint of a statistically significant improvement in severity of illness (CGI-S) at 8 weeks between NTI164 and placebo (p<0.001)

• Children in NTI164 group re-classified from markedly-severely ill (CGI-S: 5.54) at baseline to mild-moderately ill (CGI-S: 3.77) at 8 weeks, a very strong improvement

• Key Secondary endpoints examining adaptive behaviour improvements (Vineland™-3) (p=0.024), CGI-Improvement (p<0.001) social responsiveness (p=0.028), were met with strong treatment-related benefits over placebo

• No serious adverse events recorded, no changes to kidney/liver function over the 8-week period noted, no treatment-related diarrhoea and nausea/vomiting rate lower for NTI164 arm

• Neurotech to accelerate registration-related regulatory discussions given strength of data

• NDIS spend of $6.73 billion to participants with Autism highlights dire need for a safe and effective therapeutic intervention to improve ASD symptoms and reduce healthcare costs



https://www.investi.com.au/api/announcements/nti/3e87a498-65a.pdf