Anavex 2-73 (blarcamesine) safely led to significant improvements in several aspects of cognition, including choice reaction time and episodic memory, in people with Parkinson’s disease dementia (PDD), new data from a Phase 2 trial report.
According to Anavex Life Sciences, the therapy’s developer, these findings from the ANAVEX 2-73-PDD-001 study (NCT03774459) support the treatment’s continued testing in Parkinson’s dementia patients. Anavex 2-73, an investigative oral therapy, was initially developed to treat Alzheimer’s disease.
“I am very intrigued to see the promising results of the ANAVEX 2-73-PDD-001 trial, providing significant improvements in cognitive function accompanied by a favorable safety and tolerability profile,” Dag Aarsland, MD, PhD, a professor and department head at the Institute of Psychiatry, Psychology & Neuroscience, at King’s College London, said in a press release.
“The Anavex 2-73 (blarcamesine) study results represent a meaningful step forward toward urgently needed treatment for this serious complication of Parkinson’s disease given that cognitive impairment of patients … is very distressing to patients and their families and is associated with greater risk of institutionalization and accelerated progression,” Aarsland added.
Findings were presented by Aarsland in the late-breaking presentation, “ANAVEX 2-73 (blarcamesine) Currently in Phase 2b/3 Early Alzheimer’s Disease (AD): Analysis of Cognitive Outcome Measures Relevant to AD of Double-blind, Multicenter, Placebo-controlled Phase 2 Clinical Trial in 132 Patients with Parkinson’s Disease Dementia,” at the 13th international conference on Clinical Trials on Alzheimer’s Disease (CTAD), held online Nov. 4–7.
Anavex 2-73 is a small molecule activator of the sigma-1 receptor (SIGMAR1), a protein receptor that regulates aspects of cell biology relevant to neurodegeneration, and that is needed to maintain a healthy balance in brain cells.
By activating SIGMAR1, whose levels are diminished in the brains of Parkinson’s and Alzheimer’s patients, Anavex 2-73 is thought to help reduce oxidative stress, which damages cells as a consequence of high levels of oxidant molecules, and to lessen brain inflammation and toxic aggregation of the beta-amyloid and tau proteins.
As all these are known to contribute to progression in these neurodegenerative disorders, Anavex 2-73 is expected to slow neurological decline in patients.
ANAVEX 2-73-PDD-001, which concluded in September, was a proof-of-concept Phase 2 trial assessing the safety, tolerability, and early efficacy of Anavex 2-73 in people with PDD.
Its 132 patients, ages 50 to 85, were randomly assigned to one of two doses of Anavex 2-73 (30 or 50 mg oral capsules), or to a matched placebo, once daily for 14 weeks.
In addition to safety, another main study goal was changes in several aspects of cognition. These were evaluated using the cognitive drug research (CDR) computerized assessment system, which looks at multiple cognitive skills, including choice reaction time (choosing between similar objects), vigilance, and episodic memory (remembering new personal experiences or shared information).
Secondary ANAVEX 2-73-PDD-001 trial goals included assessing changes in patients’ motor abilities and sleep quality.
The new findings confirm those recently announced, supporting Anavex 2-73 as safe and well-tolerated up to a maximum dose of 50 mg once a day. The therapy’s safety profile was also superior to that of other common dementia medications, which are associated with considerable side effects.
Treatment with Anavex 2-73 also led to significant improvements in patients’ cognitive skills, including choice reaction time, vigilance, and episodic memory, potentially benefitting quality of life.
Greater improvements in episodic memory were recorded in patients treated with Anavex 2-73 at its higher, 50 mg daily dose.
Sleep was not affected in patients given Anavex 2-73 in the trial, and its use was found to have a positive effect on REM sleep behavior disorder, a condition in which patients physically act out while dreaming. This disorder is linked with greater cognitive impairment and a higher risk of dementia.
After completing this main trial, participants had the option of continuing or starting Anavex 2-73 treatment (those in the placebo group) in its long-term extension study, called ANAVEX 2-73-PDD-EP-001 (NCT04575259). This 48-week study will assess the therapy’s longer-term safety and efficacy, as well as possible treatment effects on patients’ gut bacteria.
The extension trial, like the main study, is taking place in Australia and Spain, and is expected to conclude in October 2021.
“Our strategy has been consistently to advance Anavex 2-73 (blarcamesine) … and to validate this approach in clinical studies in patients with significant cognitive impairments. We are pleased with these PDD study results that will be further supplemented by actigraphy movement data and whole genome exome DNA and RNA data,” Christopher Missling, PhD, president and CEO of Anavex, said.
The company plans to submit ANAVEX 2-73-PDD-001 trial data for publication in a peer-reviewed medical journal, and open a pivotal trial of Anavex 2-73 in Parkinson’s dementia patients with regulatory guidance from the U.S. Food and Drug Administration.
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