Anavex Life Sciences Corp. has reported findings from the 48-week, open-label extension of its Phase II study investigating individuals with Parkinson’s disease dementia (PDD).

The extension (NCT04575259), which was offered to participants after completion of a double-blind, placebo-controlled Phase II study, demonstrated beneficial effects of ANAVEX2-73 (blarcamesine) with clinical symptoms of PDD having improved longitudinally amongst the patients. ANAVEX2-73 is an oral small-molecule activator of the sigma-1 receptor.

Parkinson’s disease (PD) is the second most common neurological disorder, and more than 10 million people live with the disease globally. Around a third of individuals with PD develop dementia.  

The study met its endpoints of Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and Clinical Global Impression – Improvement (CGI-I). Improved clinical effects were contrasted with the worsening of symptoms observed in the time window between the end of the Phase II trial and commencement of extension. This so-called ‘drug holiday’ was delayed by the Covid-19 pandemic.

“It is encouraging that the patients’ clinical symptoms consistently improved longitudinally over time during the extension phase under active ANAVEX2-73 treatment,” said Christopher U Missling, president & CEO of Anavex. “This data suggests ANAVEX2-73’s potential capability to slow and potentially reverse the life altering symptoms of Parkinson’s disease, an urgent unmet global need.”

The Special Access Scheme has allowed the continued use of ANAVEX2-73 beyond the completion of the 48-week extension, at the request of the participants. Participants on the compassionate programme have now been on the treatment for more than two years.

The Michael J. Fox Foundation (MJFF) awarded Anavex a research grant of nearly $1m in 2021 for an imaging-focused Parkinson’s disease clinical trial with ANAVEX2-73.

In December 2022, the New York, US-headquartered company announced that ANAVEX2-73  met primary and secondary endpoints in a Phase 2b/3 study for patients with early Alzheimer’s disease. The industry is also awaiting results expected in H2 2023 for Rett syndrome indication.