NEW YORK – Anavex Life Sciences on Thursday said that an investigational drug it is developing for treating Alzheimer's disease slowed cognitive decline in patients and that it will share the data with regulatory authorities.
The New York-based drugmaker is studying the sigma-1 and muscarinic receptor-targeting drug blarcamesine, also known as ANAVEX 2-73, in a Phase IIb/III trial, in which around 500 patients with mild cognitive impairment or dementia due to Alzheimer's are randomized to receive either the investigational drug or a placebo for 48 weeks.
The company has now deemed this trial successful as patients treated with the drug showed a statistically significantly lower rate of cognitive decline as measured by two scores compared to those in the placebo arm. "All prespecified clinical endpoints were analyzed using a mixed model for repeated measures (MMRM)," the company said in a statement. "The MMRM analysis method is the convention used for regulatory filings and discussions with regulatory authorities are in preparation."
In the trial, blarcamesine-treated patients also had significant reductions in pathological beta-amyloid levels in plasma, and MRI scans showed slower brain atrophy compared to the control arm. Anavex further highlighted that blarcamesine demonstrated "strong anti-amyloid effects" by significantly increasing plasma Aβ42/40 ratio. In the trial, dizziness affected blarcamesine-treated patients more than those on placebo, but these headaches tended to be mild to moderate in intensity and transient, the company said.
Blarcamesine, Anavex's lead drug candidate, is designed to restore cellular homeostasis by blocking sigma-1 and muscarinic receptors. The company is also developing the drug for treating Parkinson's disease and Rett syndrome and believes the agent's anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties seen in animal models could potentially make it effective against other central nervous system disorders such as epilepsy.