Alzeihmer’s disease is sadly becoming very common. The Alzeihmer’s Association estimates that roughly 6.9 million Americans are living with this difficult form of dementia.
Sadly, it can become more prevalent as the population gets older. We talked a bit about this in our post way back in 2013. The good news is that there are new advances that can help slow its progression. One of the newest ways that people are starting to treat Alzheimer’s disease is with Anavex 2-73 therapy.
Anavex 2-73 Therapy Can Help Treat Alzeihmer’s
Anavex 2-73, an investigational oral therapy by Anavex Life Sciences Corp., has demonstrated significant efficacy in slowing cognitive decline and functional impairment in individuals with early Alzheimer’s disease, based on a recent data analysis from a Phase 2b/3 clinical trial.
Anavex is a clinical-stage biopharmaceutical company that is developing therapeutics for the treatment of a variety of neurodegenerative and neurodevelopmental disorders, including Alzheimer’s disease, Parkinson’s disease, and Rett syndrome.
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Promising Cognitive Benefits and Neuroprotection
The study revealed that Anavex 2-73, also known as blarcamesine, not only slowed cognitive decline; it also reduced brain shrinkage — a key marker of neurodegeneration — and lowered levels of amyloid-beta protein, which is associated with Alzheimer’s disease.
Michael Weiner, M.D., a professor at the University of California San Francisco, highlighted the significance of these findings in the context of objective markers of neurodegeneration, as noted in a press release by Anavex. “These data are very exciting, particularly in a study that can demonstrate objective slowing of markers of neurodegeneration,” Weiner said. Anavex is currently preparing to meet with regulatory authorities in the United States, Europe, and the Asia-Pacific region to discuss approving Anavex 2-73’s use in treating Alzheimer’s.
What is Anavex 2-73 and How Does it Work?
Anavex 2-73 is a small molecule that activates the sigma-1 receptor—a brain protein linked to various neuroprotective effects such as preventing toxic protein accumulation, reducing neuroinflammation, and alleviating oxidative stress.
The therapy aims to counteract the neurological changes underlying Alzheimer’s disease, including cognitive decline, by enhancing the activity of these receptors. Anavex is exploring its potential not only in Alzheimer’s, but also in other neurological disorders like Rett syndrome and Parkinson’s disease.
Positive Outcomes and Further Insights
The global Phase 2b/3 trial (Anavex 2-73-AD-004 [NCT03790709]) enrolled 508 individuals between the ages of 60 and 85 who have early dementia due to Alzheimer’s. Participants received either Anavex 2-73 or a placebo daily for 48 weeks.
The main goals of the trial were to evaluate the therapy’s effects on cognition using the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog) and overall function, based on the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scale (ADCS-ADL) after one year. The trial successfully met its primary objectives of assessing cognitive and functional outcomes. Anavex 2-73-treated individuals showed significant improvements in cognitive function and overall activities of daily living compared to those on a placebo.
Additionally, patients treated with Anavex 2-73 were 84% more likely to see a meaningful cognitive improvement (e.g., a drop of at least 0.5 points on the ADAS-Cog score) over those given a placebo. The treatment showed a 45% slower cognitive decline relative to a placebo and was 167% more likely to result in clinically meaningful improvements in overall function (e.g., an ADCS-ADL score increase of 3.5 points or more) over a placebo. It can be a great treatment for people in the early stages of the disorder.
It was also associated with a 27% slower decline in cognitive function per the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB). Blood analyses indicated changes in amyloid-beta levels, and brain MRI imaging revealed a reduction in brain volume loss with active treatment.
Future Prospects
Marwan Noel Sabbagh, M.D., professor of neurology at the Barrow Neurological Institute in Arizona and chairman of Anavex’s Scientific Advisory Board, emphasized the potential of therapies like Anavex 2-73 that target multiple aspects of Alzheimer’s.
“There is hope that new therapies for Alzheimer’s that target the disease beyond amyloid may slow progression for many people with the earliest forms of the disease,” Sabbagh said. He went on to say that the advantage of Anavex 2-73 “is that it is a small oral molecule that exerts clinical benefits on cognition and neurodegeneration and could be appealing because of its route of administration and excellent safety profile.”
Anavex 2-73’s oral formulation and favorable safety profile make it an appealing treatment option. The therapy was generally well tolerated, with dizziness being the most common side effect.
Anavex is optimistic about advancing Anavex 2-73 as a promising oral treatment for Alzheimer’s disease, with ongoing studies aimed at further evaluating its efficacy and safety. Those participants who completed the trial had the opportunity to enroll in an ongoing open-label extension study, where they will receive Anavex 2-73 for about two years. The extension study is expected to finish this year.
“Alzheimer’s disease is such a devastating disease that affects tens of millions worldwide, and Anavex’s clinical development is a testament to our determination to follow the science,” said Christopher Missling, Ph.D., Anavex’s president and CEO. “We’d like to thank all the people involved in the study for their invaluable contributions, and we look forward to advancing Anavex 2-73 as a potential new convenient orally available treatment option for Alzheimer’s disease.”
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