Published On: January 30th, 2024
Neurotech International (ASX: NTI) has secured authorization to commence a notable Phase I/II clinical trial of its proprietary pharmaceutical compound, NTI164. The trial is aimed at treating pediatric patients who have spastic Cerebral Palsy (CP).
The Human Research Ethics Committee (HREC) endorsement, paired with the Therapeutic Goods Administration’s clinical trial notification scheme approval, marks a pivotal advancement towards offering a novel therapeutic option for children impacted by this disorder.
The Stark Need for Treatment
Representing the majority, spastic CP encapsulates up to 80% of all CP diagnoses, making it the foremost cause of disability among children. With an estimated 750,000 affected individuals in the United States and approximately 34,000 in Australia, effective treatments have become more crucial than ever.
Concurrently, the market for CP therapies is anticipated to expand significantly, reaching an estimated $6.5 billion annually by 2030.
Examining NTI164
Central to the upcoming phase I/II trial, NTI164 is formulated from a distinct cannabis variant known for its minimal tetrahydrocannabinol levels and innovative cannabinoid composition. The trial is designed as a single-arm, open-label study aiming to enrol up to 14 pediatric patients diagnosed with non-ambulatory spastic CP.
Spanning 12 weeks, the trial’s objective is to rigorously assess the therapeutic efficacy and safety profile of NTI164, with patient recruitment set to take place at the Monash Medical Centre, Victoria.
Professor Michael Fahey, a distinguished authority in pediatric neurology with a wealth of experience in NTI164 clinical research, will lead the study.
Framing the Objectives of Trial
The foremost aim of the investigation is to collect and analyze data drawn from the caregiver priorities and child health index of life with disabilities questionnaire. This tool evaluates caregiver perceptions concerning health-related quality of life and their impact on children afflicted with CP.
Secondary objectives will review the safety parameters of NTI164 and its influence on alleviating pain, improving sleep quality, reducing seizure frequency, and mitigating the effects of dystonia and spasticity.
NTI164 aims to facilitate gross motor functionality, encourage social engagement, and enhance overall comfort. It is scheduled to launch in the first half of the 2024 calendar year.
A Glance at Neurotech’s Disruptive Therapeutic Research and Development
Neurotech ASX is extending its innovation and research into the sphere of neurodevelopmental disorders, notably focusing on Autism Spectrum Disorder (ASD).
The company is leveraging its proprietary NTI/Dolce cannabis strains, renowned for their neuro-protective, anti-inflammatory, and neuro-modulatory properties, in a groundbreaking study. The research aims to evaluate the efficacy of NTI164 in treating pediatric ASD.
In parallel, Neurotech International is commercializing Mente, a pioneering home therapy device that is the first of its kind. It is clinically proven to foster engagement and enhance relaxation in autistic children exhibiting elevated Delta brain activity.
This innovative approach represents a paradigm shift in home-based care for ASD, thus offering a non-invasive and user-friendly therapy option that can significantly impact the daily lives of affected families.
An Impressive Market Performance
Investor sentiment surrounding Neurotech International Limited ASX has shown remarkable positivity, as reflected in the company’s recent share price activity on the ASX. The latest share price of NTI: ASX Is AUD 0.09.
The overall performance metrics are compelling, with a 20.00% increase observed over the last week and a 30.43% rise over the past month and the year to date in 2024.
This growth underscores the company’s robust year-on-year expansion and highlights its outperformance against sector and ASX 200 benchmarks, registering a 17.14% and 18.42% increase, respectively.
Attracting the Investors’ Confidence
The bullish trends in share price activity signal strong investor confidence in Neurotech International strategic initiatives and its potential to redefine therapeutic approaches in both cerebral palsy and Autism Spectrum Disorder domains.
Further, with the innovation of the novel NTI164 drug, the company stands on the brink of revolutionizing the therapeutic approach to treating children with spastic diplegia cerebral palsy while also promising to improve their quality of life.
