US-based biopharmaceutical firm Anavex Life Sciences has started enrolling patients in a multi-centre Phase IIa clinical trial for ANAVEX 2-73 to treat Alzheimer’s disease (AD).
The randomised trial is designed to evaluate the safety and exploratory efficacy of ANAVEX 2-73 alone, as well as in combination with donepezil (ANAVEX PLUS) in patients with mild to moderate AD.
ANAVEX 2-73 targets sigma-1 and muscarinic receptors and in preclinical studies it has shown to reduce stress levels in the brain and to reverse the pathological hallmarks observed in AD.
The company said that in a previously performed Phase I trial, ANAVEX 2-73 showed no serious adverse events.
Caulfield Hospital in Melbourne director and associate professor Aged Psychiatry Stephen Macfarlane is serving as the principal investigator for the trial.
Anavex president and chief executive officer Christopher Missling said: "Current treatments for Alzheimer’s only address symptoms of the disease, while data from preclinical studies of ANAVEX 2-73 demonstrated the potential to directly address the pathology of Alzheimer’s disease.
"We hope that ANAVEX 2-73 and our combination compound ANAVEX PLUS will offer an effective and well-tolerated treatment option for those afflicted with Alzheimer’s disease, and we are excited to start the Phase IIa clinical trial."
The multi-centre Phase IIa trial of ANAVEX 2-73 and ANAVEX PLUS is designed as an initial dose finding trial of up to 36 days with an open-label extension trial for an additional 26 weeks.
The trial’s primary objective is to assess the maximum tolerated dose of ANAVEX 2-73 with ongoing administration in 32 mild to moderate Alzheimer’s patients.
The open-label extension trial is expected to establish a longer drug effect for patients who continue on an oral daily dose.