Anavex has revealed encouraging data from the 48-week open-label extension of their
phase 2 study of ANAVEX2-73 (blarcamesine) for treating Parkinson’s disease
dementia (PDD). Despite delays caused by the COVID-19 pandemic, the
investigational drug demonstrated significant efficacy and safety in improving PDD symptoms.
The extension phase faced delays averaging 41 weeks, which impacted enrollment and created a
“drug holiday” for participants. However, patients who resumed
treatment reported consistent improvements in their clinical symptoms over the
48-week period. Notable efficacy endpoints included the Movement Disorder
Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) Parts II and III,
and the Clinical Global Impression-Improvement (CGI-I), both showing positive results.
Christopher U. Missling, PhD, President and CEO of Anavex
Life Sciences, expressed optimism about the findings. “It is encouraging that the
patients’ clinical symptoms consistently improved longitudinally over time
during the extension phase under active ANAVEX2-73 treatment,” he stated.
Patients recorded a notable change of -2.25 in MDS-UPDRS total scores and -0.7 in CGI-I scores from
the OLE baseline to week 48. Additionally, improvements were observed in the
Montreal Cognitive Assessment and REM Sleep Behavior Disorder Screening Questionnaire
scores. The data also showed a -3.95 change in MDS-UPDRS Part III scores and a
-2.20 change in MDS-UPDRS Parts II and III combined.
Previously reported data from the double-blind period indicated that high-dose blarcamesine led to
significant improvements compared to the placebo group. Patients on the high
dose saw a -10.98 point improvement in MDS-UPDRS total scores, while the placebo
group experienced a 3.53 point decline, highlighting the drug’s efficacy.
Anavex Life Sciences plans to use these promising results as a foundation
for their upcoming 6-month PD study, with the primary endpoints focused on
MDS-UPDRS II + III and CGI-I scores. The positive impact on sigma-1 receptor
(SIGMAR1) mRNA expression further supports the drug’s potential.
This data brings hope for those suffering from Parkinson’s disease dementia, an area with
significant unmet medical needs. Anavex’s ongoing research may pave the way for
more effective treatments for this challenging condition.
Refer to this article for related information.
Learn more about Anavex on https://www.globaldata.com/company-profile/anavex-life-sciences-corp/