Neurotech Advances NTI164 with Ethics Nod for Pivotal Phase 3 Autism Trial
Neurotech International has secured ethics approval to launch its Beyond Harmony Phase 3 clinical trial of NTI164 for autism spectrum disorder, marking a key step toward regulatory submissions in Australia and the US.
- Human Research Ethics Committee approval obtained for Phase 3 trial
- Trial targets autism spectrum disorder Levels 2 and 3
- Designed to support submissions to Australian TGA and US FDA
- Led by Professor Michael Fahey with multiple clinical sites
- Builds on prior studies showing significant symptom improvements
Ethics Approval Unlocks Phase 3 Trial
Neurotech International Limited (ASX, NTI) has reached a crucial milestone with the Human Research Ethics Committee granting approval to commence its Beyond Harmony Phase 3 clinical study. This pivotal trial will evaluate NTI164, a broad-spectrum oral cannabinoid therapy, in individuals diagnosed with autism spectrum disorder (ASD) Levels 2 and 3. The green light from the ethics committee allows Neurotech to initiate site activations and begin recruiting participants across Australia, with plans to expand into the United States.
Strategic Regulatory Pathway
The Phase 3 study is designed not only to confirm the clinical benefits of NTI164 but also to generate the robust data required for regulatory submissions to both the Therapeutic Goods Administration (TGA) in Australia and the US Food and Drug Administration (FDA). This dual-jurisdiction approach underscores Neurotech’s ambition to secure market authorisation in two of the world’s most significant healthcare markets, potentially accelerating global access to the therapy.
Building on Strong Clinical Foundations
Neurotech’s confidence in NTI164 is grounded in earlier clinical trials that demonstrated statistically significant and clinically meaningful improvements across multiple core ASD symptom domains. These studies also reported consistent enhancements in caregiver-reported quality of life, lending further weight to the therapeutic potential of NTI164. The Phase 3 trial’s design reflects these findings, ensuring methodological rigour and alignment with regulatory expectations.
Expert Leadership and Expanding Clinical Network
The trial will be led by Professor Michael Fahey, a respected figure in paediatric neurology and neurodevelopmental disorders. He will be supported by a team of co-principal investigators and a network of satellite clinical sites across Australia, with progressive expansion into the US. This leadership and infrastructure are critical to managing the complexities of a large-scale, multi-site clinical trial and ensuring high-quality data collection.
Looking Ahead
With ethics approval secured, Neurotech is poised to commence study initiation activities imminently. The company has committed to providing ongoing updates as it progresses through site activations and participant recruitment. Success in this Phase 3 trial could pave the way for NTI164’s commercialisation, offering a new treatment avenue for individuals with moderate to severe ASD and their families.
Bottom Line?
Neurotech’s Phase 3 trial approval sets the stage for a critical test of NTI164’s potential to transform ASD treatment in major markets.
Questions in the middle?
- What is the expected timeline for completing the Phase 3 trial and submitting regulatory applications?
- How will Neurotech manage recruitment and retention across multiple sites in Australia and the US?
- What competitive therapies are in development for ASD Levels 2 and 3, and how does NTI164 compare?
