Anavex Life Sciences has announced a positive update in its Phase 2a study for its ANAVEX 2-73 drug that targets cellular homeostasis in mild-to-moderate Alzheimer’s disease patients.
According to the update, at 41 weeks, Alzheimer’s patients taking a daily oral dose of ANAVEX 2-73 in the exploratory showed a stabilization of cognitive and functional measures. According to Anavex, the data is promising since Alzheimer’s disease is a progressive disease where current therapeutics are only able to temporarily slow the worsening of dementia symptoms and not stop the disease from progressing.
The multicenter Phase 2a clinical trial of ANAVEX 2-73 consists of two parts and a total of 32 mild-to-moderate Alzheimer’s patients. PART A is a simple randomized, open-label, two-period, cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration, adaptive trial lasting up to 5 weeks for each patient. PART B is an open-label extension for an additional 52 weeks. Initially planned for 26 weeks, PART B was extended to 52 weeks as a result of requests from patients and caregivers.
The primary endpoint of the Phase 2a trial is to establish safety, tolerability and maximum tolerated dose (MTD) of ANAVEX 2-73, which had shown potential in preclinical studies to prevent, halt and/or reverse the course of the disease. Secondary endpoints include dose response, bioavailability, and exploratory cognitive as well as functional measures using Mini Mental State Examination (MMSE) and evaluation of Alzheimer’s Disease Co-operative Study – Activities of Daily Living Inventory (ADCS-ADL), as well as Cogstate test battery and EEG/ERP.
At 41 weeks, oral daily dosing between 10mg and 50mg, ANAVEX 2-73 was well tolerated, and no patients discontinued treatment due to adverse events. There were no clinically significant treatment-related adverse events, and no serious adverse events.
According to George Perry, PhD, Dean and Professor at the University of Texas at San Antonio and Editor-in Chief of the Journal of Alzheimer’s Disease, while this is an open label study with 32 patients he has never seen mild-to-moderate Alzheimer’s patients maintain near baseline cognitive and activities of daily living function and positive correlation with all other measures over a 41-week trial period in any prior study.
Published Alzheimer disease studies confirm substantial declines of both the cognitive (MMSE) and the functional (ADCS-ADL) measures over this timeframe in a similar AD population. In comparison to historical control from a pooled placebo arm cohort study conducted by the Alzheimer Disease Cooperative Study Group in mild-to-moderate AD patients of comparable ages and MMSE baselines, over nine months the ANAVEX 2-73 data shows a potential treatment benefit of several points on both the MMSE scale and on the ADCS-ADL score.