{"id":2640,"date":"2023-12-04T02:28:47","date_gmt":"2023-12-04T02:28:47","guid":{"rendered":"https:\/\/economicherald.net\/?p=2640"},"modified":"2023-12-04T02:28:47","modified_gmt":"2023-12-04T02:28:47","slug":"neurotech-to-extend-phase-2-3-autism-spectrum-disorder-trial-to-adults","status":"publish","type":"post","link":"https:\/\/economicherald.net\/?p=2640","title":{"rendered":"Neurotech to extend Phase 2\/3 autism spectrum disorder trial to adults"},"content":{"rendered":"

Neurotech receives HREC approval to extend Phase II\/III ASD trial to adults
\nCompany committed to developing NTI164 as a first-line treatment for patients with autism
\nTrial on track to report results during the first quarter of calendar year 2024<\/p>\n

\u00a0<\/p>\n

Special Report:<\/em><\/strong> Neurotech\u2019s Phase 2\/3 clinical trial in autism spectrum disorder (ASD) has hit another milestone after receiving approval to allow patients who turn 18 to remain on treatment during the extension trial. <\/strong>\u00a0<\/strong><\/p>\n

Neurotech International (ASX:NTI)<\/strong><\/a> has announced Human Research Ethics Committee (HREC)\u00a0 approval to\u00a0 extend\u00a0 its Phase 2\/3 clinical trial in ASD to allow patients who turn 18 to remain on treatment with its proprietary NTI164 during the extension phase for up to\u00a0 54\u00a0 weeks of total treatment.<\/p>\n

The clinical-stage biopharmaceutical development company\u00a0is focused predominately on paediatric neurological disorders.<\/p>\n

The current HREC approval for NTIASD2 \u2013 a Phase 2\/3 trial \u2013 covers treatment with NTI164 in a paediatric population of ASD.<\/p>\n

NTI164\u00a0drug formulation derived from a unique cannabis strain with low THC and a novel combination of cannabinoids including CBDA, CBC, CBDP, CBDB and CBN and is exclusively licenced for neurological applications globally.<\/p>\n

Pre-clinical studies have demonstrated the drug\u2019s potent anti-proliferative, anti-oxidative, anti-inflammatory, and neuro-protective effects in human neuronal and microglial cells.<\/p>\n

NTI164 is being developed as a therapeutic drug product for a range of neurological disorders in children where neuroinflammation is involved.<\/p>\n

\u00a0<\/p>\n

Earlier study in ASD shows success<\/strong><\/h2>\n

The double-blind, placebo-controlled Phase 2\/3 clinical trial in Australia has been assessing the efficacy of NTI164 up to 20mg\/kg\/day on the severity of ASD in up to 54 patients aged 2-17 years, now extended to beyond 18.<\/p>\n

The primary endpoint of the trial is Clinical Global Impression-Severity (CGI-S), which reflects a clinician\u2019s impression of severity of illness on a 7-point scale ranging from 1=not at all, to 7=among the most extremely ill.<\/p>\n

Results of its earlier trial show<\/a> strong safety and efficacy, with significant improvement across many assessments versus baseline (Day 0).<\/p>\n

The side effects reported were not serious or severe and did not significantly interfere with patients\u2019 functioning.<\/p>\n

No clinically significant abnormal laboratory values were reported. At 52 weeks of treatment, the mean severity of illness rating of the CGI-S was 3.0, representing an improvement of 30% from baseline.<\/p>\n

\u00a0<\/p>\n

Endpoints reached in PANDAS\/PANS trial<\/strong><\/h2>\n

In October NTI reported<\/a> paediatric patients with orphan disorder PANDAS\/PANS could have a new treatment available to them after NTI ground-breaking phase I\/II trial of NTI164 reached its primary endpoints with significant and clinically meaningful improvements.<\/p>\n

PANDA (Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections) and PANS (Paediatric Acute-Onset Neuropsychiatric Syndrome) are a collective disorder.<\/p>\n

Children go to bed perfectly normal but wake up with uncontrollable tic movements in their hands and legs and become severely obsessive compulsive with heightened anxiety and depression.<\/p>\n

This disorder is believed to manifest due to some dysregulation from streptococcus or some other unknown pathogen that initiates an autoimmune response which sees inflammation in their brain.<\/p>\n

\u00a0<\/p>\n

Need for ASD therapies remain significant<\/strong><\/h2>\n

Executive director Dr Thomas Duthy says NTI is pleased to secure the additional HREC approval for NTI164 in the patient population for the Phase 2\/3 trial into ASD.<\/p>\n

\u201cI am delighted with the progress of this large double-blind, placebo controlled clinical trial,\u201d he says.<\/p>\n

\u201cWe remain steadfastly committed to developing NTI164 as a first-line treatment for Level 2-3 patients with autism where the market need for new therapies remains significant.<\/p>\n

\u201cImportantly, with recruitment into the trial to complete during the current quarter, we are on track to report results during the first quarter of calendar year 2024 (Q3 FY24).\u201d<\/p>\n

\u00a0<\/p>\n

This article was developed in collaboration with Neurotech International, a Stockhead advertiser at the time of publishing. <\/em>\u00a0<\/em><\/p>\n

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.<\/em><\/p>\n

<\/span><\/p>\n

The post Neurotech to extend Phase 2\/3 autism spectrum disorder trial to adults<\/a> appeared first on Stockhead<\/a>.<\/p>","protected":false},"excerpt":{"rendered":"

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