A year-long extension study of the drug Anavex 2-73 (blarcamesine) has shown promising results for people with Parkinson’s disease dementia, with findings suggesting that it can safely reduce the severity of both dementia and motor symptoms. The study followed 20 participants who had previously completed a Phase 2 clinical trial of the drug.
Encouraging Results After a Drug Holiday
In the original Phase 2 trial, participants received Anavex 2-73 for about three and a half months, during which they experienced improvements in memory, cognitive function, and motor symptoms. However, a gap of more than nine months occurred between the end of that trial and the start of the extension study, during which patients were not taking the drug. During this period without treatment, participants saw a worsening of their symptoms.
Once the extension study began, participants took Anavex 2-73 daily for nearly a year. Over this time, many of the declines seen during the drug-free period were reversed, and by the end of the extension study, the median scores on a key measure of motor symptoms were similar to those observed at the end of the initial Phase 2 trial.
What is Anavex 2-73?
Anavex 2-73 is a small molecule drug being developed by Anavex Life Sciences, a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of a variety of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders.
Anavex 2-73 works by activating a protein called SIGMAR1, which plays a role in maintaining healthy brain cells. In people with neurological disorders like Parkinson’s disease, Alzheimer’s disease, and Rett syndrome, levels of SIGMAR1 are lower than normal. By stimulating this protein, Anavex 2-73 aims to slow the progression of these diseases and protect brain function.
The initial Phase 2 study involved 132 adults with Parkinson’s disease dementia. The results showed that those who took the drug once daily had improvements in cognitive abilities, as well as meaningful reductions in motor symptoms. These effects were measured using the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS), which assesses motor function and other symptoms of Parkinson’s disease.
Continued Benefits in the Extension Study
In the open-label extension study, all participants received Anavex 2-73, in addition to any other Parkinson’s medications they were already taking. The COVID-19 pandemic caused delays in the start of the extension, leading to the lengthy gap between the end of the original trial and the extension’s beginning. Despite this, once patients resumed treatment with Anavex 2-73, they showed improvements. The MDS-UPDRS scores, which had worsened during the drug-free period, improved once again during the year of treatment.
The study also showed benefits in other areas, such as overall health, cognitive decline, and sleep quality. Participants reported less-severe symptoms of REM sleep behavior disorder (RBD), a condition linked to increased cognitive decline and a higher risk of dementia in people with Parkinson’s. These improvements suggest that the drug may have broad benefits beyond just motor symptoms.
Safety and Future Plans
Blarcamesine was well-tolerated throughout the study, with no new safety concerns emerging. This aligns with previous trials, which have shown the drug to be safe over long-term use.
Looking ahead, Anavex plans to conduct a Phase 3 trial to further assess the effectiveness of Anavex 2-73. This study will focus on whether six months of treatment can significantly improve motor symptoms, as measured by the MDS-UPDRS. The trial will also evaluate overall health outcomes using a measure called the Clinical Global Impression – Improvement, which was used in the extension study.
For participants who completed the extension study, there is an option to continue receiving Anavex 2-73 through a compassionate use program. Some patients in this program have now been on the treatment for over two years, further underscoring its potential for long-term use.
The results of the extension study provide hope that Anavex 2-73 could be an effective long-term treatment for Parkinson’s disease dementia, helping to reduce both cognitive and motor symptoms. While more research is needed to confirm these findings, the promising outcomes so far suggest that this drug may one day offer a new option for managing this debilitating condition.
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