Neurotech International Ltd. · ASX:NTI
Neurotech International — Technical Presentation (October 2023)
23 slides from Neurotech International's technical presentation, Oct 6, 2023
Slide 1: PANDAS/PANS Phase I/II Clinical Trial Results
For personal use only Improving Lives PANDAS/PANS Dr Thomas Duthy Phase I/II Clinical Trial Results Executive Director 6 October 2023
Slide 2: Disclaimer
Disclaimer IMPORTANT INFORMATION Purpose of presentation: This presentation (including this document, any related video or oral These events are, as at the date of this presentation, expected to take place, but there cannot be any guarantee that such will occur as anticipated, or at all, given that
Slide 3: About PANDAS / PANS
About PANDAS / PANS What is it? Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS) – PANDAS is a subgroup of PANS For personal use only PANS and PANDAS are severe forms of obsessive-compulsive
Slide 4: Recognised Diagnostic & Treatment Guidelines
Recognised Diagnostic & Treatment Guidelines Diagnostic Criteria (2015) Treatment (2017) The PANS/PANDAS Research Consortium, in conjunction with the NIMH, The PANS/PANDAS Research Consortium, consisting over 30 experts and issued a consensus statement regarding diagnosing PANS/PANDAS in the the NIM
Slide 5: PANDAS/PANS Phase I/II Trial
PANDAS/PANS Phase I/II Trial “We encourage clinicians, teachers, providers, extended family, and friends to understand the human aspects of PANDAS/PANS as symptoms are often so distressing, causing high levels of caregiver burden. 1 For personal use only 1. https://aspire.care/what-is-pans/caregiver
Slide 6: NTI164 PANDAS/PANS Phase I/II – Trial Design
NTI164 PANDAS/PANS Phase I/II – Trial Design Enrolment • Open-label, patients must fulfil PANS criteria (n=15) • Primary Endpoints NTI164 Baseline • For personal use only Revised Children’s Anxiety and Depression Scale-Parent-rated (RCADS-P) score • Clinical Global Impression-Severity (CGI-S) • Clin
Slide 7: Selecting NTI164 for PANDAS/PANS
Selecting NTI164 for PANDAS/PANS • Preclinical and clinical studies to date have shown that NTI164 is a powerful neuro-anti-inflammatory modulator, can suppress a wide range of inflammatory cytokines, and improves neuronal cell viability • Neuroinflammation is hypothesised to be relevant to PANDAS/P
Slide 8: Baseline Patient Characteristics
Baseline Patient Characteristics Characteristic Number (%) / Mean Age 11.9 years (mean) For personal use only Male 9 (60%) Sex Female 6 (40%) PANDAS 0 (0%) A total of 15 patients with Diagnosis moderate-severe PANS 15 (100%) PANDAS/PANS recruited Moderate 3 (20%) CGI-S1 Marked 9 (60%) Severe 3 (20%)
Slide 9: Safety (12 week Data)
Safety (12 week Data) NTI164 Exhibits Excellent Safety Over 12 Weeks No serious adverse events recorded For personal use only Across all doses, across entire period (12 weeks) A total of 15 patients Adverse events were tolerated and manageable evaluable at 12 weeks 9 adverse events were recorded fro
Slide 10: Efficacy: RCADS-P (Primary Efficacy Endpoint)
Efficacy: RCADS-P (Primary Efficacy Endpoint) RCADS-P (n=15) 83.7 30% Clinical Interpretation For personal use only • Mean difference between baseline and 12 weeks was 25.5, representing a statistically significant, clinically meaningful 60.8 improvement of 30% = LOW SEVERITY v HIGH SEVERITY at Day
Slide 11: Efficacy: CGI-S (Primary Efficacy Endpoint)
Efficacy: CGI-S (Primary Efficacy Endpoint) Mean Severity of Illness (n=15) Severity of illness Scale (CGI-S) 5.5 5.0 5.0 4.5 For personal use only 1 2 3 4 5 6 7 4.0 4.1 4.0 3.5 Baseline 3.0 Week 4 Baseline Week 4 Week 12 Week 12 Clinical Interpretation CGI-Severity of illness1 (p = 0.0005) • NTI164
Slide 12: Efficacy: CGI-I (Primary Endpoint)
Efficacy: CGI-I (Primary Endpoint) CGI-Global improvement 1 7% For personal use only Clinical Interpretation 40% • After 4 weeks of treatment with NTI164, 33% of 67% Very much Improved patients were much improved, 67% minimally improved Much Improved • After 12 weeks of daily treatment with NTI164,
Slide 13: Efficacy: CGI-Therapeutic Effect (Primary Endpoint)
Efficacy: CGI-Therapeutic Effect (Primary Endpoint) CGI-Therapeutic Effect1 7% For personal use only 33% 40% Marked (1-4) Clinical Interpretation • After 4 weeks of daily NTI164 treatment, 67% of Moderate (5-8) patients demonstrated a Moderate improvement and Minimal (9-12) 33% demonstrated a Minima
Slide 14: Efficacy: YGTSS (Tic Severity) (Secondary Endpoint)
Efficacy: YGTSS (Tic Severity)(Secondary Endpoint) 52.0 YGTSS (n=15) For personal use only 45.5 44.7 Clinical Interpretation • Mean difference of -7.3, representing an improvement of 14% over baseline • Motor tic severity did not increase once patients commenced treatment with NTI164, and showed an
Slide 15: Efficacy: Conners Scale (ADHD) (Secondary Endpoint)
Efficacy: Conners Scale (ADHD)(Secondary Endpoint) Conners (n=15) 20.6 18.0 For personal use only 17.3 Clinical Interpretation • The mean total T-score for the 15 patients after 12 weeks of NTI164 treatment was 17.3 which is a significant improvement (16%) from baseline where it was 20.6 (mean diffe
Slide 16: Quality of Life: EQ-5D-Y (Secondary Endpoint)
Quality of Life: EQ-5D-Y (Secondary Endpoint) EQ-5D-Y (n=15) 83.5 80 76.7 70.6 For personal use only 60 40 Clinical Interpretation • Patient’s quality of life as measured by the EQ-5D-Y assessment improved considerably between baseline and 12 weeks of 20 treatment with NTI164 • The mean total T-scor
Slide 17: Efficacy: CY-BOCS (Secondary Endpoint)
Efficacy: CY-BOCS (Secondary Endpoint) CY-BOCS (n=15) 33.0 31.7 30.0 For personal use only Clinical Interpretation • The mean total T-score for the 15 patients after 12 weeks of NTI164 treatment was 30.0 which was an improvement (10%) from baseline where it was 33.0 (mean difference of -3.0, p=0.96)
Slide 18: NTI164 PANDAS/PANS Phase I/II – Conclusions
NTI164 PANDAS/PANS Phase I/II – Conclusions • NTI164 was safe and well tolerated in this patient population • NTI164 provided significant evidence of effect over 12 weeks of daily oral treatment For personal use only • Met primary endpoints of RCADS-Y with 30% improvement in anxiety and depression,
Slide 19: Summary
Summary • First ever broad-spectrum cannabinoid therapy to show a strong benefit in this population • All psychometric endpoints studied exhibited showed clinical improvement over time For personal use only with statistically significant and clinically meaningful improvements shown for the two key p
Slide 20: Contact Details
For personal use only Contact Details Dr Tom Duthy Executive Director [email protected] +61 402 493 727 *This presentation has been authorised by the Board of Neurotech International Limited www.neurotechinternational.com www.mentetech.com Neurotech International Limited (ASX: NTI) 20
Slide 21: Appendix
For personal use only Appendix 21
Slide 22: Neurotech is a clinical-stage biopharmaceutical development company
Neurotech is a clinical-stage biopharmaceutical development company focused predominately on paediatric neurological disorders For personal use only Novel oral NTI164 exclusive worldwide Patents Pending – biopharmaceutical licence for neurological Use, Composition cannabinoid platform disorders (NTI
Slide 23: Neurotech Four Core Strategies
Neurotech Four Core Strategies For personal use only Focus On Rare Focus on Paediatric Patients Neurological Disorders with Neuroinflammation Focus on Partnering with Focus On Drug Product Key Opinion Leaders / Development Clinicians 23
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