Neurotech International Limited (ASX: $NTI) has announced its strategic focus on pursuing a targeted global partnering strategy for NTI164 and registration-directed initiatives in Australia. The company aims to secure strategic partnerships for NTI164 in the United States, Europe, and certain Asian territories, while also pursuing multiple registrations of NTI164 in Australia, leveraging the provisional registration pathway via the TGA. Neurotech's initiatives are aimed at reducing financial, clinical, and regulatory risks for its shareholders.
Dr Thomas Duthy, Executive Director of Neurotech International, emphasized the company's core focus on generating conclusive clinical evidence for the efficacy and safety of NTI164 for pediatric neurological patients. He highlighted the company's strong position to leverage robust clinical data, intellectual property, and manufacturing expertise to deliver significant value to shareholders through global corporate development and domestic regulatory submissions in Australia. Dr Duthy also stressed the importance of pursuing an active strategy for the unique pediatric neurological franchise, aiming to address rare diseases with limited or no treatment options.
Neurotech International's strategic initiatives involve securing strategic partnerships for NTI164 globally and pursuing multiple registrations in Australia. The company aims to complete FDA IND-enabling studies and secure FDA IND approval for NTI164 clinical trials in at least one neurological disorder. Additionally, Neurotech plans to leverage the provisional registration pathway via the TGA for expedited commercialization in Australia. The company's focus on pediatric neurological disorders aligns with the significant market opportunity in Australia, particularly in addressing autism, PANDAS/PANS, and Rett Syndrome. Neurotech's efforts are geared towards reducing financial and clinical risks internationally while maximizing the potential of its unique pediatric neurological franchise.