Anavex Life Sciences says its Alzheimer’s drug candidate Anavex 2-73 may have a role in treating the disease. Data from a long-term extension trial, although small, indicated that the therapy improved cognitive and functional measures in patients.
According to data presented during the recent 10th Clinical Trials on Alzheimer’s Disease (CTAD) Meeting in Boston, the most benefit was seen in early-stage patients treated with higher doses of the drug, which appeared safe across three studies.
“We are cautiously optimistic about the promising results of Anavex 2-73 observed in patients who have received the drug for over two years,” Christopher Missling, president and CEO of New York-based Anavex, said in a press release.
Anavex 2-73 — stimulating the Sigma-1 receptor to reduce cell stress and modulate neuroplasticity and cell health — has been studied in three trials; a Phase 1 study, a Phase 2a study (NCT02244541) and an open-label long-term extension study (NCT02756858).
At 57 weeks of the two-year trial, patients receiving the highest doses improved on measures of cognitive decline and functional ability, demonstrated by a test of daily living activities.
The study’s main objective was, however, to assess its safety. Anavex reported that Anavex 2-73 had a favorable safety and tolerability profile throughout the 109 weeks of the trial. In addition, data from the Phase 1 and Phase 2a studies confirmed the notion of a dose-response relationship — demonstrating that higher doses provide better outcomes.
The one-third of patients with the highest drug concentration were twice as likely to experience an improved score on the cognitive test as patients on lower doses. They were also more than one and a half times more likely to improve on functional daily living tests over 57 weeks. The two studies also showed that early-stage patients responded better to Anavex 2-73 than those with moderate dementia.
In addition, researchers noted no differences in how the drug is processed in the bodies of men and women, and confirmed that Anavex 2-73 does not affect a heartbeat property called the QT interval. An abnormally prolonged QT interval — triggered by many types of drugs — can give rise to arrhythmias.
The findings have encouraged Anavex to proceed with the planning of a Phase 2/3 trial, for which it will use a precision medicine approach — characterizing patients using DNA and gene activity analyses as well as exome gut microbiome characterization.
“We are committed to advancing Anavex 2-73, utilizing all relevant scientific knowledge we can learn, in hopes of helping those affected by the disease,” said Missling.