Anavex is a new drug from a company called Anavex Life Sciences that is targeting Alzheimer’s and other dementias.
Alzheimer’s disease breaks down the brain at a cellular level and changes your everyday functions. Your ability to think clearly, remember and personality change. As the disease progresses, so do the symptoms and at this time there is no cure. While there are drugs on the market to help with the worsening of symptoms (like Aducanumab / Aduhelm), there isn’t anything that helps restore the damages already done to the brain but Anavex hopes to do this by cleaning up and fixing damaged cells. Anavex (also known as Blarcamesine) is still in its clinical trials but has already given people hope in its ability to go beyond the treatment of solely helping Alzheimer’s patients but to also encompass other neurodegenerative diseases affecting the central nervous system like Rett’s syndrome and Parkinson’s Disease.
Intended for mild to moderate Alzheimer’s, Anavex is a pill that would be taken once a day and is showing promises of stopping (and possibly reversing) the brain’s break down by restoring health to damaged cells. Since we know that patients with Alzheimer’s have less sigma-1 receptors compared to a healthy patient, this discrepancy and decline are what make this new medication unique.
In this article we will look at how Anavex works, the benefits and side effects of the medicine, the status of the clinical trials and its projected availability, cost, and insurance coverage.
Anavex works at the cellular level to jump start the sigma-1 receptors and make healthier cells. This approach focuses on sigma-1 receptors as the keys to unlock the breakdown that is associated with Alzheimer’s. These receptors are long strands of proteins that are located in the endoplasmic reticulum whose job is to regulate activity of itself (and has the capability to control other proteins around it) by preventing cellular transfer of calcium. The job of sigma-1 receptors is to help with the folding of proteins, calcium and energy exchange, fat absorption and transportation. Anavex acts as a chemical that activates the sigma-1 receptors so cellular repair can begin and also prevents worsening of the brain and its functions.
Anavex´s goal is to slow the progression and heal damaged cells in the brains of Alzheimer’s patients. Working at the biological level, the benefits are:
– Ability to clean up and restore damaged cells
– Fix misfolded proteins which are a necessary tool to activate the sigma-1 receptor which “act(s) to restore physiological or behavioral functions”
– Reduces the build up of beta-amyloid protein plaques that cause cells to malfunction
– Minimizes its inflammation response in the brain
With so many positives, how can one doubt this newly developed drug? The side effects, thus far, are minor dizziness and headaches. Researchers have said that because they are working at the cellular level there is a chance that other cells and systems are affected but as of yet this is unknow.
As of the time of writing, Anavex is in Phase 2b/3 of its clinical trials for Alzheimer’s disease. As mentioned above, it is exciting to see this drug in similar stages for other neurodegenerative diseases causing the breakdown of the central nervous system (it is in Phase 3 for Retts Syndrome, Phase 2 for Parkinson’s disease dementia and Phase 1 for Parkinson’s disease).
Beginning in Germany on a test group of healthy men, the drug was studied for its safety and ability as it moved through the metabolism and was absorbed in the body. Passing on to the next stage in the trial, in 2014 Phase 2 focused on 32 Alzheimer’s patients (16 male and 16 female) who had been diagnosed with mild to moderate symptoms and broken into two parts. Part A was a short 5-week trial, again aiming at the drug’s safety, the patient’s ability to tolerate it and the maximum dose they were able to withstand.
All 32 participants were invited back into part B, where the mission of the trial was the same (to look closely at dose and effect connection) but for an extended 26-week period where researchers and patients actively shared information on what drug and the dose they were taking.
With results being positive and leading to further observation, a 3-year study began. Its goal was proving effectiveness and safety over a long period of use. By testing patients through cognitive assessments, researchers found thinking, reasoning and memory all had “significant association” with Anavex. Continued positive research in 2018 led into Phase 2b/3, where scientists led a double blind placebo controlled study expanding the test group to 450 participants. Scientists studied dose (either 30 or 50mg taken once a day) and its effectiveness at taking Anavex over a long amount of time (48 weeks). Patients showed improvement based on cognitive assessments that were done before, during and after the study.
Continuing in its current stage, in 2021 an oversight safety board recommended expanded trials conducted using the same criteria and using patients from Canada, Australia, Germany, the Netherlands and England. More information is anticipated to be published in mid 2022. However, the studies are not expected to wrap until 2024.
For more information about Anavex’s clinical trials, including open ones for Alzheimer’s disease, Parkinson’s disease and Rett’s syndrome visit this page on Clinicaltrails.gov.
The golden question with all new medicine is when is it going to be available to me? The answer is we don’t know. Researchers are looking to finish up Phase 2b/3 in summer 2024 and that means that the longevity of the drug will have been thoroughly studied but will still need FDA approval. The FDA approval passes after Phase 3 is complete and the medicine is proven safe and effective.
Anavex’s cost is not known yet because like most pharmaceutical companies, they are not priced until they are fully brought to market with FDA approval and ready to be sold.
Noting that FDA approval is key for how this new drug will affect us financially, it is also not known if Medicare, Medicaid and/or private insurance will cover Anavex.