New Alzheimer’s Drug Shows Positive Dose-Response in Phase 2 Trial

New Alzheimer’s Drug Shows Positive Dose-Response in Phase 2 Trial
Anavex Life Sciences Corp. reported that a positive dose-response relationship has been observed in its ongoing Phase 2a clinical trial of ANAVEX 2-73 as a potential treatment for mild-to-moderate Alzheimer’s disease (AD). The announcement came as part of a planned, interim study analysis. The ANAVEX 2-73 Phase 2a study is a multicenter trial in 32 mild-to-moderate Alzheimer’s patients. The primary endpoint is evaluation of the safety and tolerability of ANAVEX 2-73, an orally available drug candidate that targets sigma-1 and muscarinic receptors. Secondary endpoints include bioavailability, dose response, and exploratory cognitive effects using Mini Mental State Examination (MMSE), Cogstate battery, electroencephalographic (EEG) activity and event-related potentials (ERP), and evaluation of the Alzheimer's Disease Co-operative Study-Activities of Daily Living Inventory (ADSC-ADL). A further secondary endpoint is the evaluation of ANAVEX 2-73 as an add-on therapy to donepezil, the current standard of care. The company reported that the drug was seen to  prevent, halt, and even reverse disease course in preclinical studies. The ANAVEX 2-73 trial is divided into two parts:
  • Phase 2a is a simple, open-label, randomized, cross-over between oral (30mg/50mg) and IV (3mg/5mg) administration, two-period, lasting up to five weeks for each patient.
  • Phase 2b an open-label extension study for 52 weeks. This phase was initially planned for 26 weeks, and extended at the request of AD patients and caregivers.
"While we remain cautious about interpreting the results of an interim an
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