{"id":458354,"date":"2021-03-16T07:03:09","date_gmt":"2021-03-16T11:03:09","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=458354"},"modified":"2021-03-16T07:03:09","modified_gmt":"2021-03-16T11:03:09","slug":"anavex-life-sciences-reports-anavex2-73-blarcamesine-featured-as-a-disease-modifying-small-molecule-in-phase-3-clinical-trials-in-a-new-publication-in-medical-journal-titled-future-av","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/anavex-life-sciences-reports-anavex2-73-blarcamesine-featured-as-a-disease-modifying-small-molecule-in-phase-3-clinical-trials-in-a-new-publication-in-medical-journal-titled-future-av\/","title":{"rendered":"Anavex Life Sciences Reports ANAVEX\u00ae2-73 (blarcamesine) featured as a Disease-Modifying Small Molecule in Phase 3 Clinical Trials in a New Publication in Medical Journal titled \u201cFuture Avenues for Alzheimer\u2019s Disease Detection and Therapy\u201d"},"content":{"rendered":"
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NEW YORK, March 16, 2021 (GLOBE NEWSWIRE) — Anavex Life Sciences Corp. (\u201cAnavex\u201d or the \u201cCompany\u201d) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer\u2019s disease, Parkinson\u2019s disease, Rett syndrome and other central nervous system (CNS) diseases, today reported that ANAVEX\u00ae<\/sup>2-73 (blarcamesine<\/em>) is featured in a recent peer-reviewed publication in the journal of Neuropharmacology<\/em><\/a>, titled \u201cFuture avenues for Alzheimer\u2019s disease detection and therapy: liquid biopsy, intracellular signaling modulation, systems pharmacology drug discovery<\/em>\u201d from the series of the special issue on \u2019The Quest for Disease-Modifying Therapies for Neurodegenerative Disorders<\/em>\u2019.1<\/sup><\/p>\n

The authors of the paper describe gene biomarkers associated improved drug response with consistent results across the different measurements of both cognition and activities of daily living and function with ANAVEX\u00ae<\/sup>2-73, a selective SIGMAR1 agonist, observed in a 57-week multicenter\u00a0Phase 2a open-label adaptive design clinical trial (ANAVEX2-73-002) of 32 mild-to-moderate Alzheimer\u2019s disease patients (aged 55\u201385). They declare that Alzheimer\u2019s disease patients with fully operational SIGMAR1 gene show improved benefits with ANAVEX\u00ae<\/sup>2-73, whereas those carrying gene variants have a limited benefit. Since the majority of the population, around 80%, has a totally functional SIGMAR1 gene, most of patients are supposed to benefit from ANAVEX\u00ae<\/sup>2-73.<\/p>\n

They further state that SIGMAR1 stimulation prevents A\u03b2-induced neurotoxicity and moreover, that SIGMAR1 activation is associated with a significant slow-down of Alzheimer\u2019s disease-related excitotoxicity, thus promoting synaptic remodeling with improved plasticity. In addition, the biomarker-driven clinical data is described, thus, enabling targeted therapy and a precision medicine-guided approach. PET scan data previously confirmed dose-dependent target engagement of SIGMAR1 with ANAVEX\u00ae<\/sup>2-73.2<\/sup><\/p>\n

The precision medicine knowledge from this study was incorporated into the design of the currently ongoing and presently over 86%-enrolled placebo-controlled 450-patient Phase 2b\/3 ANAVEX\u00ae<\/sup>2-73 clinical study in Alzheimer’s disease including the above characterized SIGMAR1 gene as prespecified endpoints and utilizing differentiated patient selection criteria using ADAS-Cog (cognition) and ADCS-ADL (activities of daily living and function) as primary endpoints.3<\/sup><\/p>\n

The Neuropharmacology<\/em> publication noted that in the clinical study, 57 weeks of oral once daily ANAVEX\u00ae<\/sup>2-73 treatment showed patients improved cognition scores by +2.0 points on MMSE, a 9% mean improvement from baseline to 57 weeks, corresponding to a calculated ADAS-Cog score change of -3.4 (improvement). In these same patients ANAVEX\u00ae<\/sup>2-73 also improved ADCS-ADL, by +4.9 points, a 7% mean improvement from baseline to 57 weeks.<\/p>\n

An extension of the published study (ANAVEX2-73-003) demonstrated that for the same patients at week 70 MMSE scores improved by +3.0, a 14% improvement from baseline, corresponding to a calculated ADAS-Cog score change of -5.1 (improvement). In these same patients, ANAVEX\u00ae<\/sup>2-73 also improved ADCS-ADL, by +6.0 points, an 8% mean improvement from baseline to 70 weeks. The mean MMSE and ADCS-ADL baseline scores for these patients in this study were 22.3 and 71.1, respectively.4<\/sup>,<\/sup>5<\/sup><\/p>\n

This data seems to be consistent with the effect of ANAVEX\u00ae<\/sup>2-73 on cognition assessed in the recently completed placebo-controlled Phase 2 study of 132 patients with Parkinson\u2019s disease dementia (ANAVEX2-73-PDD-001) with once-daily administration of oral 30 mg ANAVEX\u00ae<\/sup>2-73, 50 mg ANAVEX\u00ae<\/sup>2-73 and placebo for 14 weeks. The observed statistically significant improvement of CDR system Episodic Memory of +42.22 between 50 mg ANAVEX\u00ae<\/sup>2-73 and placebo was also dose-dependent (p = 0.003).6<\/sup> CDR system Episodic Memory has been shown to be highly correlated (70%) with the ADAS-Cog score (r = 0.7).7\u00a0<\/sup>The calculated corresponding ADAS-Cog mean change from baseline score is -1.9 (improvement) for patients in the 50 mg dose group, an 8% mean improvement from baseline to 14 weeks. The difference between the ANAVEX\u00ae<\/sup>2-73 group and the placebo group in the change from baseline at 14 weeks was a 4.0-point improvement of calculated corresponding ADAS-Cog score (p = 0.015).<\/p>\n

The Mini-Mental State Exam (MMSE) and the ADAS-Cog (Alzheimer’s Disease Assessment Scale\u2013Cognitive Subscale) are standard tests for assessing changes in cognition in Alzheimer\u2019s disease trials and known to correlate to a high degree.8<\/sup> The ADCS-ADL (Alzheimer\u2019s Disease Cooperative Study\u2013Activities of Daily Living), assesses the competence of patients with Alzheimer\u2019s disease in basic and instrumental function or activities of daily living.<\/p>\n

Alzheimer\u2019s is a progressive disease and over time, a patient\u2019s cognition will always worsen. \u201cExperience based on longitudinal studies of ambulatory patients with mild to moderate Alzheimer\u2019s disease suggest that scores on the ADAS-cog worsen by 6-12 points per year\u201d <\/em>with the annualized rate of decline might be smaller depending on the disease stage, according to FDA\u2019s Prescription Information sheet for ARICEPT\u00ae<\/sup> (donepezil), a drug approved for the treatment of dementia of the Alzheimer\u2019s type.9<\/sup><\/p>\n

While the placebo-controlled 450-patient Phase 2b\/3 ANAVEX\u00ae<\/sup>2-73 clinical study in Alzheimer’s disease is currently ongoing, prior clinical research in Alzheimer\u2019s disease conducted by other sponsors can serve as a contextual reference for estimates of an expected rate of decline in cognition (MMSE and ADAS-Cog) and function (ADCS-ADL) in placebo patients:<\/p>\n