Quarterly Activities Report
for the period ending 31 March 2024
Neurotech International Limited (ASX: NTI) (‘Neurotech’, ’NTI’ or ‘the Company’ a clinical-stage biopharmaceutical development company focused predominately on paediatric neurological disorders, is pleased to present its activities report for the quarter ended 31 March 2024 (Q3 FY24),
together with its Appendix 4C Quarterly Cash Flow Report.
CLINICAL UPDATES
Autism Spectrum Disorder
On 7 February 2024, the Company provided an update on the progress of the 11 autism spectrum disorder (ASD) patients who were part of the Company’s world-first Phase I/II clinical trial
examining the daily use of Neurotech’s proprietary broad spectrum cannabinoid drug therapy,
NTI164 out to 52 weeks of treatments, as initially announced in March 2023.
All patients have crossed 90 weeks of daily oral therapy with NTI164.
Neurotech reported that NTI164 continued to exhibit an exceptional safety and tolerability profile,
with all patients showing stable blood chemistries and normal liver and kidney function over 90 weeks.
This is the longest ever study in ASD examining the safety of a broad-spectrum cannabinoid drug treatment.
The Company received qualitative feedback from parents/caregivers on their child’s ASD, as quoted below.
A parent of one paediatric participant who has continued treatment past 90 weeks said:
“We are so privileged to be a part of a revolutionary study that has enabled our child to participate in everyday activities which would have been very stressful and almost impossible to do in the past. To be able to participate in school sports and camp is something we never imagined we could achieve. We are very grateful.”
A second parent of a patient on the extension study commented:
“The impact of our son’s autism has had a profound impact on our family unit. We have had to cut back on our career’s, our social events, holidays and basic everyday activities. To be able to participate in a study that has not only enhanced our son’s quality of life but has also improved our lives as a family unit is remarkable in every sense.”
Professor Michael Fahey, Head of the Paediatric Neurology Unit at Monash Medical Centre, Director of Neurogenetics and Chief Investigator of the NTI164 Phase I/II Trial said:
“I am delighted with the progress of my patients under this long term extension to our original Phase I/ll clinical trial, which sought to examine the safety and efficacy of NTI164 following 30 days of daily oral therapy. To have 11 patients still on treatment past 90 weeks is testament to the durable responses we have seen in our patients coupled with a remarkable safety profile of this intervention in Level 2 and 3 autism patients. We therefore eagerly await the results of the double-blind, placebo-controlled Phase II/III clinical trial to confirm these earlier clinical findings."
Professor Michael Fahey, Chief Investigator of the NTI164 Phase I/II Trial said:
“This second long-term extension to our core clinical program which commenced in mid-2022 and reported 52 week safety and efficacy data in March 2023
reflects the significant progress my patients have made,
and their caregivers strong desire to continue treatment over the long term.
The lack of side-effects with NTI164 and the significant clinical improvements we’ve observed in these patients necessitates a long-term treatment plan. We thank Neurotech for their continued support of our early study patients and we look forward to the results of our larger double-blind, placebo-controlled Phase II/III clinical trial in ASD.”
On 17 April 2024, the Company released very strong clinical trial results from the randomised, doubleblind, placebo-controlled Phase II/III ASD clinical trial of NTI164 versus placebo in Level II and Level III Autism Spectrum Disorder (ASD) patients. The data is summarised within the Post Quarter Events section, below.
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- Ann: Quarterly Activities/Appendix 4C Cash Flow Report
Ann: Quarterly Activities/Appendix 4C Cash Flow Report, page-2
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