At least in the Blarcamesine Parkinson’s study Anavex previously reported (Aug. 2022) that “SIGMAR1 mRNA expression significantly increased in ANAVEX®2-73-treated patients vs placebo (p=0.035) over the course of treatment and was significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system.”
Anavex said then that: “These findings will facilitate contextualization of upcoming readout of ANAVEX®2-73 Phase 2b/3 Alzheimer’s disease clinical trial”
ANAVEX®2-73 transcriptomics analysis (RNAseq) identified a gene network that is differentially expressed in Parkinson’s disease dementia (PDD) patients treated with ANAVEX®2-73 compared to placebo after 14 weeks of treatment. The expression of 14,150 genes were analyzed from both placebo and ANAVEX®2-73 treated patients. Biological relevance of this gene network was assessed through pathway analysis and confirmed the impact of ANAVEX®2-73 treatment on pathways involved in neurodegenerative diseases, especially Alzheimer’s disease and Parkinson’s disease.
While genes are known to be down-regulated in Alzheimer’s disease1 and Parkinson’s disease2, representing pathology for these diseases, ANAVEX®2-73 singularly impacted expression levels of these genes in multiple pathways by countering the pathological down-regulation of genes in both Alzheimer’s (p<0.005) and Parkinson’s disease (p<0.005) and other degenerative diseases (p<0.005).
The scope of these detected gene expressions identified through ANAVEX®2-73 effect may represent additional potential biomarkers of disease pathology and response. Previously, this study demonstrated dose-dependent, statistically significant improvement of dementia assessment, Quality of Episodic Memory with ANAVEX®2-73 (p=0.003) as well as significant improvement of Parkinson’s assessment, MDS-UPDRS Total score (p=0.034), in patients treated with ANAVEX®2-73 high oral dose once daily during the 14-week trial. SIGMAR1 mRNA expression significantly increased in ANAVEX®2-73-treated patients vs placebo (p=0.035) over the course of treatment and was significantly associated with improvements of MDS-UPDRS scores and cognitive efficacy endpoints CDR system.3
So, Anavex is trying to correlate SIGMAR1 mRNA expression increase in ANAVEX®2-73-treated patients (maybe 30-50 patients?) as the biomarker to support approval of its drug for Alzheimer’s? If so, do you have any idea what the CDR-SB score may be for the 30-50 patients? Did anyone at CTAD have any opinion about that?
Endpoints not the point says Dr. Oph EMA more concerned with biomarkers. Precision Medicine...endpoints not the point....this board is barking up the wrong tree woof woof !!
I did buy shares today after I ate quinoa and amaranth for breakfast. I drank white tea also. After watching the manipulation of the stock price for awhile I did get my shares. The shorts use the same catch words for all the bios to deceive like changed endpoints had yadda yada.
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