The 54th and final patient has completed their last visit as part of Neurotech’s Phase II/III clinical trial of its NTI164 cannabinoid drug candidate for children with Autism Spectrum Disorder (ASD).
The trial recruited patients aged 8-17 who have now completed eight weeks of daily NTI164 treatment (the randomisation period of the trial) at the Paediatric Neurology Unit at Melbourne’s Monash Medical Centre.
Neurotech executive director Dr Thomas Duthy said: “With the explosion in autism-associated costs under the Australian National Disability Insurance Scheme (NDIS), there is an urgent need for new enabling treatments like NTI164, which has been shown to significantly improve adaptive behaviours and socialisation and improve these children’s quality of life in an earlier clinical trial.”
The results will inform Neurotech’s discussions with the Therapeutic Goods Administration (TGA) regarding a pathway to market approval in Australia where the prevalence of autism is estimated at 1 in 50 across the population, representing a 40-fold increase in the last 20 years.
Duthy said more recent 2023 data from the NDIS suggests a prevalence rate of 1 in 25 for 7-14-year-olds with a primary diagnosis of autism, “which is among the highest rates in the world”.
Trial results are expected in early Q2 CY2024.
Meanwhile, the company has signed a binding term sheet with Melbourne-based contract research organisation Fenix Innovation Group.
Fenix will work exclusively with Neurotech in the medicinal cannabis field and the development of NTI164.
Under the terms of the partnership and subject to shareholder approval, the company has agreed to issue 10 million ordinary shares to Fenix (or its nominees) upon the signing of a definitive agreement.
Fenix has agreed to voluntarily escrow the upfront issue of shares for a period of 12 months from the date of issue.
Neurotech has also agreed to issue Fenix (or its nominees) 50 million performance rights, with vesting conditions based upon the achievement of certain regulatory and commercialisation milestones including orphan drug designations, partnering transactions, and TGA approval of NTI164 in Australia over the next three years.
Dr Duthy said: “Fenix has been integral in the development of NTI164 since 2019, efficiently overseeing the manufacturing and preparation of drug product, regulatory submissions, clinical trial protocol development, management of clinical trials and key opinion leader development.
“The alignment of Neurotech’s development objectives with Fenix is expected to result in the execution of our overall clinical and commercial development pathways in a much more time and cost-effective way than would otherwise be the case, given the alignment of equity-based incentives for Fenix to deliver meaningful outcomes for Neurotech.”
Fenix chief financial officer and director Sharon Smithwick added: “Fenix has dedicated substantial resources into the various NTI164 programs for Neurotech, such is our belief in the potential of this therapy to significantly improve children’s clinical symptoms without any safety compromise across a range of neurological disorders involving persistent or progressive neuroinflammation.”
