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Thursday, October 12, 2017 7:05:20 AM
Press Release: Anavex Life Sciences Reports PK and PD Data from Phase 2a Trial of ANAVEX(R)2-73 in Mild-to-Moderate Alzheimer's Disease Patients; Conference call today at 8:30am ET
Anavex Life Sciences Reports PK and PD Data from Phase 2a Trial of ANAVEX(R)2-73 in Mild-to-Moderate Alzheimer's Disease Patients; Conference call today at 8:30am ET
ANAVEX2-73 demonstrates desirable PK/PD properties, describing the relationship between drug concentration and the effect observed
Anavex is incorporating advanced Artificial Intelligence platform for the analysis of Phase 2a results with the aim to increase the chances of success in forthcoming Phase 2/3 study
NEW YORK, Oct. 12, 2017 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (Nasdaq:AVXL) today announced 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.
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(R) 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."
On the conference call scheduled for this morning, Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex will be joined by Professor George Perry, PhD and Mohammad Afshar, MD, PhD, President and CEO of Ariana Pharma to discuss new findings from the ANAVEX2-73 Phase 2a trial. Further data will be presented at the Clinical Trials on Alzheimer's Disease (CTAD) meeting in November 2017.
Conference call and webcast information
Anavex will host a conference call at 8:30 a.m. ET today, October 12, 2017. The call will be webcast live at http://www.wsw.com/webcast/cc/avxl2 and slides are accessible through the investor relations section of the Company's website at www.anavex.com. To join the call live via telephone dial 1-866-866-1333 within the United States or 1-404-260-1421 from outside the United States. A replay of the call will also be available for a period of three months through the Company's website shortly after the call.
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