Anavex has announced encouraging findings from its 48-week, open-label extension of the
phase 2 study for its investigational drug, ANAVEX2-73 (blarcamesine). This
study, involving patients with Parkinson’s disease dementia (PDD), demonstrated
significant clinical improvements despite a delay caused by the COVID-19 pandemic.
The trial’s delay resulted in a “drug holiday” for participants, but even so, those who
resumed treatment with ANAVEX2-73 showed consistent improvement. Key efficacy
end points, such as the Movement Disorder Society-Unified Parkinson’s Disease Rating
Scale (MDS-UPDRS) Parts II and III and Clinical Global Impression-Improvement
(CGI-I), were notably better at the 48-week mark compared to the baseline.
Christopher U. Missling, PhD, President and CEO of Anavex Life Sciences, expressed optimism about these results. He noted, “It is
encouraging that the patients’ clinical symptoms consistently improved
longitudinally over time during the extension phase under active ANAVEX2-73 treatment.”
From the open-label extension baseline to week 48, investigators observed a change of –2.25 in
MDS-UPDRS total score and –0.7 in CGI-I score. Additionally, the Montreal
Cognitive Assessment and REM Sleep Behavior Disorder Screening Questionnaire
also showed positive changes, reflecting the potential capabilities of
ANAVEX2-73 in addressing symptoms of PDD.
Previously reported data indicated that patients on high-dose ANAVEX2-73 from Anavex
Life Sciences, experienced a relative improvement of 18.9% over 14 weeks, compared to those on
placebo. This improvement was further supported by molecular data, indicating
significant restoration of dysregulated neurodegenerative genes.
The phase 2 study included 132 patients randomly assigned to receive either 30 mg or 50 mg of
ANAVEX2-73, or a placebo, for up to 14 weeks. Participants were allowed to
continue their stable regimens of existing Parkinson’s disease medications.
Given the limited sample size, the results warrant cautious interpretation. Still, the promising
data has led Anavex Life Sciences to continue offering the drug to participants
through a compassionate use Special Access Scheme. Looking ahead, Anavex Life
Sciences plans to incorporate the key findings from this study into a
forthcoming 6-month PD study. Refer to this article for additional information.
Follow them on Instagram.com