Anavex Life Sciences Corp (OTCMKTS:AVXL) shares were flat on Tuesday and up 3.34% in after-hours trading to $0.11. The company has a market cap of $121.41 million at 35.71 million shares outstanding. Share prices have been trading in a 52-week range of $2.43 to $8.40.
Anavex Life Sciences Corp is a clinical-stage biopharmaceutical company that is engaged in the development of differentiated therapeutics for the treatment of neurodegenerative diseases, including drug candidates to treat Alzheimer’s disease and other central nervous system diseases, pain and various types of cancer. ts lead compounds ANAVEX 2-73 and ANAVEX PLUS, a combination of ANAVEX 2-73 with donepezil are being developed to treat AD and other CNS diseases.
Aside from that, Anavex Life Sciences Corp has a product pipeline which includes ANAVEX 3-71, ANAVEX 1-41 and ANAVEX 1037. Its SIGMACEPTOR Discovery Platform produces small molecule drug candidates with modes of action, based on its understanding of sigma receptors. Sigma receptors may be targets for therapeutics to combat many human diseases, including Alzheimer’s. ANAVEX 3-71 is a preclinical drug candidate with a mechanism of action through sigma-1 receptor activation and M1 muscarinic allosteric modulation.
In a press release on Tuesday, Anavex Life Sciences Corp announced a positive 41-week update from its Phase 2a study in mild-to-moderate Alzheimer’s diseasepatients for ANAVEX 2-73, which targets cellular homeostasis. In 41 weeks, patients taking a daily oral dose of ANAVEX 2-73 in the Phase 2a clinical trial showed a stabilization of cognitive and functional measures. Aside from that, oral daily dosing between 10mg and 50mg of ANAVEX 2-73 was well tolerated, and no patients discontinued treatment due to adverse events.
“Although this is an open label study with 32 patients, I have never seen mild-to-moderate Alzheimer’s patients maintain near baseline cognitive and activities of daily living function and positive correlation with all other measures over a 41-week trial period in any prior study with an approved or experimental drug. It is quite plausible that complex CNS diseases like Alzheimer’s may require a comprehensive approach, including restoration of cellular homeostasis,” remarked George Perry, PhD, Dean and Professor at the University of Texas at San Antonio.
Alzheimer’s disease is a progressive disease where current therapeutics are only able to temporarily slow the worsening of dementia symptoms and not stop the disease from progressing. Studies confirm substantial declines of both the cognitive and the functional measures over this time frame in a similar population. In comparison to other studies, ANAVEX 2-73 data shows a potential treatment benefit of several points on both the MMSE scale and on the ADCS-ADL score.
We are encouraged, however, we should be reminded that these endpoints are exploratory and need to be confirmed in a larger study, for which planning is underway,” said Christopher Missling, PhD, President and CEO of Anavex Life Sciences Corp. “This data provides valuable safety, tolerability and behavioral information for ANAVEX 2-73, which might allow us to also target shorter-term endpoints including behavioral and psychological symptoms.”
The multicenter Phase 2a clinical trial consists of two parts and a total of 32 mild-to-moderate Alzheimer’s patients: one simple randomized, open-label, two-period, cross-over between oral and IV administration lasting up to five weeks and another open-label extension for an additional 52 weeks. Its primary endpoint is to establish safety, tolerability and maximum tolerated dose of ANAVEX 2-73 and further positive updates on the trials could mean strong upside for Anavex Life Sciences Corp stock.
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