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.
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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.
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By GlobalDataThe 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.
