Anavex has announced promising results from the 48-week open-label extension of its Phase 2
study, showcasing the efficacy and safety of its investigational drug,
ANAVEX2-73 (blarcamesine), for treating Parkinson disease dementia (PDD).
Despite challenges posed by the COVID-19 pandemic, which delayed the study’s start by
approximately 41 weeks and led to a reduced enrollment rate, patients who
continued treatment with blarcamesine experienced significant improvements. The
key efficacy endpoints, such as the Movement Disorder Society-Unified
Parkinson’s Disease Rating Scale (MDS-UPDRS) and the Clinical Global
Impression-Improvement (CGI-I), displayed consistent enhancement over the 48-week period.
Christopher U. Missling, PhD, President and CEO of Anavex
Life Sciences, expressed optimism regarding these findings. “It is encouraging that
the patients’ clinical symptoms consistently improved longitudinally over time
during the extension phase under active ANAVEX2-73 treatment,” he
remarked. This reinforces the potential of ANAVEX2-73 to address the urgent,
unmet medical needs associated with Parkinson’s disease.
The study’s results are noteworthy. From the open-label extension baseline to week 48,
investigators observed a mean change of –2.25 in the MDS-UPDRS total score and
–0.7 in the CGI-I score. These improvements suggest that blarcamesine may not
only slow but also potentially reverse the progression of PDD symptoms.
Further, the drug demonstrated a positive impact on cognitive functions and sleep disorders,
critical areas affected by Parkinson’s disease. Specifically, the Montreal
Cognitive Assessment score showed a mean change of –1.2, and the REM Sleep
Behavior Disorder Screening Questionnaire indicated a change of –0.524.
The continued administration of blarcamesine under a compassionate use Special Access Scheme
highlights its potential long-term benefits. Moving forward, Anavex Life Sciences plans to incorporate these findings into a larger,
forthcoming 6-month study, focusing on the primary and secondary endpoints
observed in the Phase 2 trial.
The data from Anavex underscores a significant stride in the quest to manage Parkinson
disease dementia, providing hope for both patients and the medical community. Refer
to this article, for related information.
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