Anavex Life Sciences Therapeutic Reduces Plaque in Alzheimer’s Brains Without Dangerous Side Effects

Updated on June 13, 2024

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Anavex Life Sciences Corp. recently held its second quarter 2024 conference call, with the company sharing new information regarding its Alzheimer’s disease drug, blarcamesine. The European Union is currently working with Anavex to examine blarcamesine’s clinical trial results and other factors for possible approval for use in combating Alzheimer’s disease.

Anavex is a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of a variety of neurodegenerative and neurodevelopmental disorders. These include Alzheimer’s disease, Parkinson’s disease, Rett syndrome, and schizophrenia.

Better Than Expected

During the call, Anavex CEO Christopher Missling, Ph.D., discussed data from the Phase 2b/3 drug trial of blarcamesine, which showed that the drug significantly slowed the cognitive decline associated with Alzheimer’s disease. The clinical effect was complemented by two biomarkers: lower levels of beta-amyloid plaques and a significant slowing in the rate of pathological brain atrophy. [1] 

This outcome involving plaques is intriguing, given that blarcamesine is engineered to modify brain chemistry upstream of beta-amyloid production. Unlike Biogen’s Leqembi (lecanemab-irmb), blarcamesine is not designed to directly clear beta-amyloid plaques from the brain. This suggests that working upstream, blarcamesine works by preventing the production of these plaques, including clearing them out.

In addition, blarcamesine may facilitate brain autophagy, a process involved in cellular recycling and self-regulation. Anavex previously described that the drug supports autophagy. In such a case, the brain may be clearing plaques on its own via autophagy, aided by blarcamesine.

Missling also emphasized that the drug trial demonstrated blarcamesine’s ability to prevent brain shrinkage (loss of brain mass) among Alzheimer’s patients — perhaps the most significant finding within the study. If the preservation of brain mass is an effect of blarcamesine-mediated autophagy, this would of course be of great value, not only to patients suffering from the disease and early onset patients in particular, but to those with a familial history of Alzheimer’s.

More Data on the Way

The ongoing 96-week extension study will offer further insights into blarcamesine’s effects, with results anticipated later this year. This program allows participants from the Phase 2b/3 trial to continue using blarcamesine regardless of their initial assignment to treatment or placebo groups.

There is optimism regarding blarcamesine’s potential approval, particularly following the FDA’s recent guidance on early Alzheimer’s disease trials. The guidance suggests that demonstrating a deceleration in cognitive decline, as measured by Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog) scores, could be sufficient to establish efficacy.

While the ADAS-Cog primarily assesses cognitive abilities, other tests focus on behavioral aspects and daily functioning, often involving caregiver input. Blarcamesine, while effective in slowing cognitive decline, did also perform well in the combined cognitive and behavioral assessment, CDR-SB.

Lecanemab, Biogen’s competing Alzheimer’s treatment, can cause brain bleeding, which has led to some patient fatalities[3] . Despite this, it has received FDA approval. The efficacy of blarcamesine, as gauged solely by the ADAS-Cog, could position it favorably for approval, considering its earlier impact on cognitive decline without the severe safety concerns associated with lecanemab.

The forthcoming publication of a journal article detailing the complete dataset on blarcamesine, along with data from the 96-week extension trial later this year, could provide further clarity on the drug’s effectiveness.

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