Neurotech International (ASX: NTI) is marking a significant period of advancement in its mission to develop NTI164, a proprietary broad-spectrum oral cannabinoid therapy, for rare paediatric neurological disorders. The company has unveiled a series of critical achievements, including robust clinical data, strategic leadership appointments, and key manufacturing agreements, positioning NTI164 for accelerated development and potential commercialisation.
NTI164 Demonstrates Significant Clinical Promise Across Paediatric Neurological Conditions
NTI164, a unique medicinal cannabis-derived biopharmaceutical, has shown considerable promise in clinical trials targeting challenging paediatric neurological conditions. Studies have consistently highlighted NTI164’s ability to deliver statistically significant and clinically meaningful improvements with an excellent safety profile. In trials for Autism Spectrum Disorder (ASD), the Phase II/III Harmony Study met all primary and key secondary endpoints, demonstrating significant improvements in anxiety, depression, and mood. Data from these studies indicated that NTI164 treatment led to marked improvements in socialisation, school attendance, and classroom behaviour, along with reductions in anxiety, irritability, and hyperactivity.
Further validation comes from trials in PANDAS/PANS (Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections / Paediatric Acute-Onset Neuropsychiatric Syndrome), where extension data showed continued improvements in clinical functionality and a significant down-staging of illness severity. In Rett Syndrome, Phase I/II and extension studies have reported functional improvements across multiple domains without serious adverse events. The company has also seen positive results in work related to PANDAS/PANS, with genomic and proteomic analyses suggesting NTI164 may reverse immune dysregulation.
Supporting these findings, a first-in-human pharmacokinetics study confirmed that NTI164 is rapidly absorbed, maintains sustained plasma concentrations, and demonstrates predictable dosing with excellent tolerability, crucial factors for its suitability in paediatric patient populations.
Strategic Leadership Enhancements Drive Forward Momentum
Neurotech International has bolstered its medical and executive leadership to steer the company’s strategic objectives. Dr. Bonni Goldstein, a leading US authority in cannabinoid medicine with over 25 years of clinical experience, including 17 years focused on cannabinoid therapeutics, has been appointed Chief Medical Advisor (USA). Her expertise in treating thousands of children with conditions like autism spectrum disorder, epilepsy, and Rett syndrome, is expected to significantly enhance the company’s medical leadership, clinical advancement, and patient advocacy, particularly within the United States.
In February 2025, Dr. Anthony Filippis assumed the role of Managing Director and Chief Executive Officer. With over 25 years of experience in sector leadership, partnering, and capital markets across the biotechnology and healthcare sectors, Dr. Filippis brings a strong commercial acumen and a proven track record in driving strategic partnerships and capital raising to advance clinical programs. His appointment signals a sharpened focus on commercialisation and global strategy for NTI164.
Securing Global Standards and Corporate Realignment
To ensure the highest quality and scalable manufacturing of NTI164, Neurotech has entered into a development agreement with RH Pharma, a subsidiary of European Cannabis Company. This partnership is designed to produce NTI164 to global pharmaceutical standards, utilising RH Pharma’s expertise in product development, manufacturing, and scale-up of cannabis-based products.
In a strategic move to concentrate its resources and capital exclusively on the development and commercialisation of NTI164, Neurotech has made the decision to divest its Mente neurofeedback device subsidiaries, placing them into voluntary liquidation. This corporate realignment underscores the company’s commitment to advancing its flagship cannabinoid therapy as its primary focus.
Navigating Regulatory Pathways and Future Innovations
Neurotech International is actively progressing its regulatory strategy, having secured orphan drug designation for NTI164 from both the US Food and Drug Administration (FDA) and the European Commission, and provisional designation in Australia. The company is pursuing a dual regulatory pathway, engaging with the Therapeutic Goods Administration (TGA) in Australia and the FDA in the US, aiming for timely market access and to provide novel therapeutic options for children with significant unmet medical needs.
The advancements in clinical data, leadership, manufacturing, and strategic focus signify a new era for Neurotech International, reinforcing its position as a key player in the development of innovative cannabis-based therapies for paediatric neurological disorders. This concerted effort aims to bring a potentially life-changing new cannabis product to patients and families worldwide.
