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Sunday, November 27, 2022

Anavex Life Sciences Corp (NASDAQ: AVXL) On Watch as Biotech to Present Results for its Phase 2b/3 Trial for blarcamesine for Alzheimer’s Disease

Anavex Life Sciences Corp (NASDAQ: AVXL) is an exciting biotech small cap caps targeting the holy grail of medicine; Alzheimer’s disease and other neurodegenerative diseases. The Company is at a pivotal point and will present results from its phase 2b/3 trial for blarcamesine for Alzheimer’s disease at the CTAD conference in San Francisco on December 1st; a condition of significant unmet need and economic burden for which there are only limited approved pharmacological treatment options. More on the phase 2b/3 trial in the conclusion of this article. 

On November 7 AVXL announced the U.S. Food and Drug Administration’s (FDA) has granted Orphan Drug Designation (ODD) to ANAVEX®2-73 (blarcamesine) for the treatment of Fragile X syndrome. Fragile X syndrome (FXS) is the most common form of inherited intellectual disability and the most frequent single gene cause of autism spectrum disorder with an estimated population of approximately 62,500 in the US and 1,088,500 worldwide.1 At present, there is no approved treatment for Fragile X syndrome. 


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Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer’s disease, Parkinson’s disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer.

Anavex’s lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a clinical trial for Alzheimer’s disease, a Phase 2 proof-of-concept study in Parkinson’s disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy.

The Michael J. Fox Foundation for Parkinson’s Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson’s disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer’s disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation.

Microcapddaily first reported on AVXL on April 2, 2015 after AVXL had reversed off $0.15 lows on the OTCQB stating at the time: “Currently trading at a $12.8 million market valuation AVXL does have $7 million in the treasury and is fully funded going forward. Now that the stock has made a significant reversal off $0.15 after years of steady decline and the Company is presenting promising preclinical data for both ANAVEX 2-73 and ANAVEX 3-71, Investors are giving AVXL another look.

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AVXL

On November 7 AVXL announced the U.S. Food and Drug Administration’s (FDA) has granted Orphan Drug Designation (ODD) to ANAVEX®2-73 (blarcamesine) for the treatment of Fragile X syndrome. Fragile X syndrome (FXS) is the most common form of inherited intellectual disability and the most frequent single gene cause of autism spectrum disorder with an estimated population of approximately 62,500 in the US and 1,088,500 worldwide.1 At present, there is no approved treatment for Fragile X syndrome. 

The FDA’s Orphan Drug Designation program provides orphan status to drugs defined as those intended for the treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation qualifies the sponsor of the drug for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval. Anavex Life Sciences’ product portfolio platform includes drug lead candidate ANAVEX®2-73 for the treatment of Alzheimer’s disease, Parkinson’s disease dementia, Parkinson’s disease and Rett syndrome and ANAVEX®3-71 for schizophrenia, frontotemporal dementia, and Alzheimer’s disease. 

AVXL CEO Christopher U Missling stated: “The Orphan Drug Designation highlights the potential to expand the therapeutic profile of ANAVEX®2-73 into the largest portion of autism spectrum disorder, Fragile X syndrome. We look forward to working with the Fragile X syndrome community to rapidly advance ANAVEX®2-73 as a potential treatment for Fragile X syndrome while we continue to expand late-stage clinical investigation of ANAVEX®2-73 as part of its precision medicine platform technology for both neurodevelopmental and neurodegenerative indications.” 

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AVXL is quickly emerging as one of the most exciting stocks in small caps targeting the holy grail of medicine; Alzheimer’s disease and other neurodegenerative diseases. Alzheimer’s is among the top 10 leading causes of deaths in the United States.  As we have always said here at Microcapdaily on AVXL the Company has got everyone’s attention; AVXL is sitting on drugs in development that could potentially disrupt several billion-dollar markets. Anavex will present results from its phase 2b/3 trial for blarcamesine for Alzheimer’s disease at the CTAD conference in San Francisco on December 1st; a condition of significant unmet need and economic burden for which there are only limited approved pharmacological treatment options. In a past trial, Anavex’s blarcamesine modified mild Alzheimer’s disease in some patients at 148 weeks. At higher concentrations, 4 out of six individuals with mild Alzheimer’s disease or mild cognitive impairment improved at 57 weeks and 3 of these six individuals retained these improvements at 109 weeks. If these numbers hold up in the larger trial and blarcamesine meets safety requirements, the FDA could grant the drug accelerated approval. AVXL was a big runner that saw a historic rise starting in 2014 when we first covered it below $0.20 when it was trading on the OTCQB to over $30 per share on the NASDAQ during the summer of 2021. We will be updating on AVXL when more details emerge so make sure you are subscribed to Microcapdaily.

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Disclosure: we hold no position in AVXL either long or short and we have not been compensated for this article

 

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