Anavex announces preliminary results from study of ANAVEX2-73-PDD-EP-001

Anavex Life Sciences reports preliminary 48-week open-label extension Parkinson’s disease dementia ANAVEX(R)2-73-PDD-EP-001 Phase 2 study data which demonstrated longitudinal beneficial effects of ANAVEX(R)2-73 on the prespecified primary and secondary objectives, as well as planned primary and key secondary endpoints which will be utilized in a forthcoming pivotal study of ANAVEX(R)2-73 in Parkinson’s disease. The 48-week ANAVEX2-73-PDD-EP-001 Phase 2 study assessed safety, tolerability and efficacy, measuring among others, Movement Disorder Society-Unified Parkinson’s Disease Rating Scale Parts I, II, III, REM Sleep Behavior Disorder Screening Questionnaire, Clinical Global Impression – Improvement, as well as cognitive efficacy endpoint Montreal Cognitive Assessment over a 48-week period. Preliminary analysis reveals that ANAVEX(R)2-73was found to be generally safe and well tolerated; and safety findings in this study are consistent with the known safety profile of ANAVEX(R)2-73. In respect to efficacy, across all efficacy endpoints, patients performed better while on ANAVEX(R)2-73. The 48-week Open Label Extension ANAVEX2-73-PDD-EP-001 Phase 2 study was offered to participants after completion of the double-blind placebo-controlled ANAVEX2-73-PDD-001 Phase 2 study. Due to the COVID-19 pandemic, the start of the extension phase was delayed, on average, by approximately 41 weeks at the end of the preceding double-blind placebo-controlled study. This led to a reduced enrollment rate for the extension phase. All efficacy endpoints, which includes the MDS-UPDRS Part II + III and Clinical Global Impression – Improvement measured at the end of trial of the double-blind study, the OLE Baseline, OLE Week 24, and OLE Week 48, showed a worsening during the drug holiday. However, a consistent improvement was observed during the extension phase when patients resumed ANAVEX2-73 treatment.