Anavex Life Sciences Corp. (NASDAQ:AVXL) has revealed on Wednesday at the Alzheimer’s Association International Conference (AAIC) 2016 a 31-week efficacy report about the ongoing ANAVEX 2-73 Phase 2a clinical trial in mild-to-moderate Alzheimer’s disease.
31-Week Data
So far, the efficacy report shows a consistent response for all quantitative secondary endpoints, which include cognitive and functional measures such as Alzheimer’s Disease Cooperative Study— Activities of Daily Living (ADCS-ADL), Cogstate and Electroencephalographic Activity and Event-Related Potentials (EEG/ERP), and Mini Mental State Examination (MMSE). The primary endpoint of the study is to evaluate the safety, efficacy, and tolerability, and determine the maximum tolerated dosage (MTD) of ANAVEX 2-73.
According to Associate Professor Stephen Macfarlane, FRANZCP, Dementia Centre HammondCare Head of Clinical Governance, the promising results over the past 31 weeks highly indicate the ability of ANAVEX 2-73 to maintain active memory functions.
Christopher Missling, Ph.D., Anavex Life Sciences CEO and President, cited the design of the Phase 2a clinical trial as adaptable for the patients without compromising their well-being. In line with this, Missling noted that the company is already planning for a Phase ⅔ clinical trial.
ANAVEX 2-73
Last month, ANAVEX 2-73 has received from the US Food and Drug Administration (FDA) an Orphan Drug Designation for the treatments of infantile spasms. This follows the granting of the Orphan Drug Designation last May to ANAVEX 2-73 for the treatment of Rett syndrome.
Such designation is granted to treatments that have potential therapeutic benefits for safely curing rare diseases, which affect less than 200,000 individuals in the US. Treatments with Orphan Drug Designations are entitled to prioritized consultations with the US FDA and numerous development program and commercialization incentives.
In June, Anavex Life Sciences has also issued encouraging data of ANAVEX 2-73 from an exploratory study for the treatment of Fragile X syndrome. With a Fragile X syndrome rat model, the company noted that ANAVEX 2-73 has potential therapeutic benefits for those who are suffering from Fragile X syndrome and Autism Spectrum Disorders as well.
