Anavex Life Sciences has reported pharmacokinetic (PK) and pharmacodynamic (PD) data for ANAVEX2-73 from its positive Phase 2a study in mild-to-moderate Alzheimer’s disease patients. ANAVEX2-73 targets the sigma-1 receptor, which regulates neuroplasticity and cellular homeostasis.
Anavex previously reported the Phase 2a trial successfully achieved both primary and secondary endpoints at the pre-specified 57-week analysis.
The company said that data announced today establishes a clear concentration-effect relationship between ANAVEX2-73 and study measurements. These measures obtained from all patients during 57 weeks include cognitive and functional scores as well as a biomarker signal of brain activity. Additionally, ANAVEX2-73 activity appears to be enhanced by its active metabolite (ANAVEX19-144), which also targets the sigma-1 receptor with a half-life approximately twice as long as the parent molecule.
“I welcome such a thorough analysis of data before moving into a Phase 2/3. The intriguing ANAVEX2-73 data shown thus far exemplifies a precision medicine approach, to my knowledge, the first of its kind to broaden the scope of drug development in Alzheimer’s disease and other central nervous system diseases,” said George Perry, PhD, Dean of the College of Sciences at The University of Texas at San Antonio and editor-in-chief of the Journal of Alzheimer’s Disease.
The Company is identifying the best responders to ANAVEX2-73 by using Ariana Pharma’s KEM advanced Artificial Intelligence technology. This cutting edge trial analysis will be used to more effectively design the upcoming Phase 2/3 clinical study, raising the odds of late stage trial success.
“We continue to be encouraged by the data from our Phase 2a clinical trial for ANAVEX2-73,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “We believe that through a systematic analysis of ANAVEX2-73 we might be able to increase the potential impact ANAVEX2-73 may have on this devastating condition.”