Blarcamesine Deemed Safe and Effective in Phase 2 Extension Study by Anavex Life Sciences
Anavex Life Sciences has released promising findings from the 48-week,
open-label extension of its phase 2 study, ANAVEX2-73-PDD-EP-001, showcasing
the potential of its investigational agent, ANAVEX2-73, also known as
blarcamesine, in treating Parkinson’s disease dementia (PDD). Despite a delay
in the start of the extension phase due to the COVID-19 pandemic, the patients
who opted to continue treatment demonstrated significant improvements in PDD
symptoms.
During the extension phase, all efficacy endpoints, including the Movement Disorder
Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III,
and Clinical Global Impression-Improvement (CGI-I), consistently showed
improvement as patients resumed treatment. The results indicate that
blarcamesine has the potential to slow and potentially reverse the
life-altering symptoms of Parkinson’s disease, addressing an urgent unmet need
in the global population.
The study recorded a change of -2.25 (SE, 6.656) in the MDS-UPDRS total score and a change of -0.7
(SE, 0.309) in CGI-I from the extension baseline to week 48. Furthermore,
patients experienced mean changes of -1.2 (SE, 0.537) in the Montreal Cognitive
Assessment and -0.524 (SE, 0.620) in the REM Sleep Behavior Disorder Screening
Questionnaire at this time point. Notably, specific MDS-UPDRS scores showed
mean changes of -3.95 (SE, 4.067) in Part III and -2.20 (SE, 5.314) in Parts II and III combined.
These promising results build upon the previously reported improvements observed in the
double-blind period. Patients receiving high-dose blarcamesine demonstrated
significant improvements in MDS-UPDRS total score compared to the placebo
group. Furthermore, blarcamesine showed a positive effect on rapid eye movement
(REM) sleep behavior disorder without impairing sleep.
Anavex Life Sciences’ phase 2 study included 132 patients with PDD who were
randomized to receive blarcamesine or placebo for up to 14 weeks. The
encouraging clinical outcomes observed in this study highlight the potential of
blarcamesine in slowing and reversing the progression of Parkinson’s disease symptoms.
These findings pave the way for further research and development of blarcamesine as a potential
therapeutic option for individuals with Parkinson’s disease dementia, offering
hope for improved quality of life and disease management. Anavex continues to prioritize the advancement of innovative treatments that address the
urgent needs of patients living with neurodegenerative disorders.
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More about Anavex Life Sciences on https://finance.yahoo.com/quote/AVXL/