Neurotech International's New Strategy for NTI164: Global Partnerships and Australian Registration
NTI (NTI) Share Update August 2024 Sunday 11th
Neurotech International Announces Strategic Global Partnerships and Australian Registration Initiatives
Neurotech International Ltd (ASX: NTI) has announced a comprehensive strategy focusing on securing global partnerships and pursuing multiple registrations for its drug therapy NTI164 in Australia.
Instant Summary:
- Neurotech to secure strategic partnerships for NTI164 in the US, Europe, and certain Asian territories.
- Pursue multiple registrations of NTI164 in Australia via the TGA's provisional registration pathway.
- Complete FDA IND-enabling studies and secure FDA IND approval for NTI164 clinical trials.
- Focus on paediatric neurological disorders such as Rett Syndrome, ASD, and PANDAS/PANS.
- Strategy aims to deliver significant value and reduce risks for shareholders.
Strategic Global Partnerships
Neurotech International Ltd is committed to securing one or more strategic partnerships for NTI164 in the United States, Europe, and certain Asian territories. These partnerships will support clinical, regulatory development, manufacturing, and future market launches of NTI164.
Prospective partners will be responsible for all costs of development and commercialization of NTI164 outside of Australia. This strategy will allow Neurotech to focus its resources on the Australian market, where it intends to maintain 100% commercial ownership of NTI164.
Australian Registration Initiatives
Neurotech plans to leverage the provisional registration pathway via the Therapeutic Goods Administration (TGA) to secure multiple registrations of NTI164 in Australia. The company believes the Australian market represents a significant annual opportunity for NTI164, especially for paediatric neurological disorders.
Neurotech aims to complete the necessary pre-clinical toxicology and human pharmacokinetic (PK) studies to support future regulatory initiatives, including clinical trials in the US and Europe. The company plans to file for FDA IND and EMA CTA approvals for paediatric clinical trials by the first half of 2025.
Intellectual Property and Manufacturing
Since mid-2022, Neurotech has invested in developing a defendable 'Asset Moat' around NTI164, including securing PCT patent applications that provide protection until at least 2041. The company has established a fully integrated, GMP-compliant process for NTI164 and proprietary methods for extraction, fractionation, isolation, and analytical chromatographic methods.
Neurotech has also lodged its first Orphan Drug Designation (ODD) request for PANDAS/PANS with the FDA, with further ODD filings planned for Rett Syndrome and PANDAS/PANS in Europe.
Market Opportunity in Australia
Neurotech has analyzed the market opportunity in Australia for NTI164, focusing on three neurological disorders: Autism Spectrum Disorder (ASD), PANDAS/PANS, and Rett Syndrome. The company estimates that there are approximately 169,000 Level II/III autism patients, 1,000 PANDAS/PANS patients, and 380 Rett Syndrome patients in Australia who may benefit from NTI164 treatment.
Neurotech believes that NTI164 has shown significant clinical benefits and safety in its trials, making it a promising treatment option for these disorders.
The announcement of strategic global partnerships and Australian registration initiatives is likely to have a positive impact on Neurotech's stock. The potential for NTI164 to address significant unmet medical needs in paediatric neurological disorders could attract investor interest and drive stock price appreciation.
Investor Reaction:
Analysts are likely to react positively to Neurotech's comprehensive strategy, given the significant market opportunities and the potential to reduce financial and clinical risks through strategic partnerships. The focus on securing multiple registrations in Australia and leveraging the TGA's provisional registration pathway is also expected to be well-received.
Conclusion:
Investors should closely monitor Neurotech's progress in securing strategic partnerships and advancing its regulatory initiatives for NTI164. The company's focus on addressing significant unmet medical needs in paediatric neurological disorders presents a compelling investment opportunity.