Neurotech International is conducting clinical studies to assess the neuro-protective, anti-inflammatory and neuro-modulatory activities of our proprietary NTI164 broad spectrum cannabinoid drug therapy.
Neurotech Four Core Strategies
Focus on Paediatric Patients
Focus on Rare Neurological Disorders with Neuroinflammation
Focus on Partnering with Key Opinion Leaders / Clinicians
Focus on Drug Product Development
Neurotech Target Markets
Ground-breaking NTI164 treatment to improve quality of life.
Neurotech has completed a Phase II/III randomised, double-blind, placebo-controlled clinical trial in Autism Spectrum Disorder (ASD) with clinically meaningful and statistically significant benefits reported across a number of clinically-validated measures and excellent safety. In addition, Neurotech has completed and reported statistically significant and clinically meaningful Phase I/II trials in ASD and Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS), collectively PANDAS/PANS along with Rett Syndrome. Neurotech has received human ethics committee clearance for a Phase I/II clinical trial in spastic cerebral palsy.
Neurotech Phase I/II ASD Clinical Trial
Trial Design
NTIASD1 was a single-arm, open-label, Phase I/II clinical trial that recruited 14 paediatric patients with a clinical diagnosis of level II and level III Autism Spectrum Disorder (ASD) to determine the efficacy and safety of orally administered NTI164 in these patients. The primary endpoints of the trial were safety and tolerability and secondary endpoints included Clinical Global Impression (CGI) of severity (CGI-S) and improvement (CGI-I).
Key Results
- At four weeks, 93% of patients showed symptom improvement relating to the severity of illness after daily treatment with NTI164.
- Strong safety and efficacy effects of daily oral treatment with NTI164 maintained at 52 weeks in the treatment of children with Autism Spectrum Disorder (ASD).
- Continued excellent durability of results, with clinical benefits showing a significant improvement across a large number of clinically validated assessments versus baseline (Day 0) and additional improvement from 20 week analysis reported in October 2022.
- After 52 weeks of treatment, gold-standard ASD measures versus baseline for clinical improvement; severity of illness (p=0.032), social responsiveness (p=0.049) and adaptive behaviour (p=0.028) were highly significant and clinically meaningful.
- Significant, positive effects on severity of illness, with children re-classified from moderately ill (CGI-S: 4.3) at baseline to baseline of borderline/mildly ill (CGI-S: 3.0) at 52 weeks, representing a 30% improvement (p=0.03) No serious adverse events recorded and no changes to blood analysis or liver function tests over the full 52 week period across all doses (5, 10, 15 and 20 mg/kg).
Neurotech Phase II/III ASD Clinical Trial
Trial Design
NTIASD2 was a Phase II/III Double-Blind, Randomised and Controlled-to-Open-Label Study to assess the efficacy of NTI164 up to 20mg/kg/day on the severity of spectrum disorder (ASD) in up to 54 patients aged 2-17 years (inclusive). The primary endpoint of the trial was Clinical Global Impression-Severity (CGI-S), which reflects clinician’s impression of severity of illness on a 7-point scale ranging from 1=not at all to 7=among the most extremely ill.
Key Results
- NTIASD2 Phase II/III clinical trial met the primary endpoint of a statistically significant improvement in severity of illness (CGI-S) at 8 weeks between NTI164 and placebo (p<0.001).
- Children in NTI164 group re-classified from markedly-severely ill (CGI-S: 5.54) at baseline to mild-moderately ill (CGI-S: 3.77) at 8 weeks, a very strong improvement.
- Key Secondary endpoints examining adaptive behaviour improvements (Vineland™-3) (p=0.024), CGI-Improvement (p<0.001) social responsiveness (p=0.028), were met with strong treatment-related benefits over placebo.
- No serious adverse events recorded, no changes to kidney/liver function over the 8-week period noted, no treatment-related diarrhoea and nausea/vomiting rate lower for NTI164 arm.
Neurotech Phase I/II PANDAS/PANS Clinical Trial
Trial Design
NTIPANS1 was a single-arm, open-label, Phase I/II clinical trial that recruited 15 paediatric patients with a clinical diagnosis of moderate to severe PANDAS/PANS to determine the efficacy and safety of orally administered NTI164 in these patients. The primary endpoints of the trial are the change from baseline at twelve (12) weeks for the Revised Children’s Anxiety and Depression Scale-Parent-rated (RCADS-P) score and Clinical Global Impression (CGI) of severity (CGI-S) and improvement (CGI-I).
Key Results
- First ever clinical trial to show highly significant clinical improvements in PANDAS/PANS patients (n=15) with a broad spectrum cannabinoid drug therapy (NTI164) with excellent safety.
- Statistically significant and clinically meaningful improvements shown across a range of gold-standard, clinically validated assessments over 12 weeks of NTI164 treatment.
- Primary endpoint of anxiety and depression (RCADS-P) met (p=0.016) with a 30% improvement in overall symptoms from high severity at baseline to low severity from week 4 onwards.
- Primary endpoint of severity of illness: Children re-classified from markedly ill at baseline (CGI-S: 5.0) to moderately ill at 12 weeks (CGI-S: 4.1), an 18% improvement (p=0.0005).
- NTI164 daily use provided further significant improvements in the severity of their illness (38% improvement at 52 weeks versus baseline) and their anxiety and depression as measured by the Revised Child Anxiety and Depression Scale – Parent Version (RCADS-P; 45% improvement at 52 weeks versus baseline).
Neurotech Phase I/II Rett Syndrome Clinical Trial
Trial Design
The NTIRTT1 Phase I/II clinical trial examined the effects of daily oral treatment of NTI164 with 14 Rett Syndrome patients. The trial was an open-label, exploratory study, over 16 weeks of treatment with NTI164 at the maximum tolerated dose or 20mg/kg/day. The primary endpoint at 12 weeks of treatment is the change in Clinical Global Impression Scale-Improvement (CGI-I).
Key Results
- Clinical Global Impression – Improvement (CGI-I) at 12 weeks versus baseline on four core Rett-anchors highlighted 93% of patients (pts) improved with 36% “very much/much improved” (p=0.001).
- Key secondary endpoint, the Rett Syndrome Behavioural Questionnaire (RSBQ) showed a mean difference of -13.4 versus baseline (p<0.001) and a 205% improvement from week 4 to week 12.
- A single serious adverse event recorded over 12 weeks of treatment (urticaria); adverse events were minimal and manageable (0% pts with diarrhoea, 14% pts vomiting, 0% pts with weight loss).
Pathways to Commercialisation
- Focused on paediatric neurological disorders
- Selected orphan drug designation(s) in the USA and Europe
- Other regulatory levers associated with a focus on paediatric patients
- US Food and Drug Administration (FDA) new drug registration
- European Medicines Agency (EMA) new drug registration
- Therapeutic Goods Administration (TGA) Australian new drug registration
- Partnering/licensing opportunities – global or key markets
Biopharmaceutical
- FDA new drug registration
- Huge potential upside
- Partnering/licensing opportunities
Strong Patent Position
Neurotech has three patent families to underpin future worldwide commercialisation in neurological applications of NTI164. Two families have now entered the national phase and one family has entered the international (PCT) phase.
Composition
Uniqueness of the NTI-164 strain – composition profile with low THC (<0.3%) and a unique combination of ‘rarer’ cannabinoids: CBDA, CBC, CBDP, CBDB & CBN
Lodged Oct 2021
Combination
The application, formulation and use of NTI164
Lodged Oct 2021
Methods
The application, formulation and use of NTI164 in paediatric patients