Safety Board Recommends Trial of Anavex 2-73 Continues as Planned
After reviewing interim trial data, an independent safety board has recommended that Anavex Life Sciences continues a trial, without modification, of its oral therapy Anavex 2-73 (blarcamesine) in people with early Alzheimer’s disease.
The board made a similar recommendation after an interim analysis earlier this year. Such a committee comprises a group of external experts tasked with monitoring clinical trials to ensure the safety of participants and the integrity of the data.
Anavex is expecting that top-line data from the Phase 2b/3 clinical trial, called Anavex 2-73-AD-004 (NCT03790709), will be available in the second half of 2022, according to a press release.
Anavex 2-73 is a small molecule that works by activating sigma-1, a protein receptor in the brain. Activating this receptor may lessen clinical symptoms and is thought to protect against neurologic changes by targeting protein misfolding (a hallmark of Alzheimer’s), problems with mitochondria (a cell’s energy producers), inflammation, and oxidative stress — an imbalance between the production of metabolic byproducts, such as reactive oxygen species, and a cell’s ability to detoxify them.
While levels of sigma-1 typically increase with age, people with Alzheimer’s tend to have lower levels of the protein receptor than their similarly aged peers.
The trial has enrolled 509 participants at 54 locations in Australia, Canada, Germany, the Netherlands, and the U.K. All participants are 60 to 85 years old and have mild cognitive impairment or early-stage mild dementia due to Alzheimer’s disease.
Participants are being randomly assigned to one of two doses of Anavex 2-73, or a placebo, for 48 weeks (about a year). Those who complete this placebo-controlled part of the trial can enroll in an open-label extension study called ATTENTION-AD (NCT04314934), wherein all participants will get the active treatment for 96 weeks (about two years) and be monitored for long-term safety and efficacy.
The trial is evaluating the effect of Anavex 2-73 on patients’ cognitive function and their ability to go about daily life activities. Safety and tolerability are being monitored as well.
The treatment is also being tested in trials for Parkinson’s disease, Parkinson’s disease with dementia, and Rett syndrome.
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