ANAVEX™ 2-73 is an orally available drug candidate developed to potentially modify Alzheimer’s disease rather than temporarily address its symptoms. It has a clean Phase 1 data profile and shows reversal of memory loss (anti-amnesic properties) and neuroprotection in several models of Alzheimer’s disease.
Successful Phase 1 Clinical Trial
A Phase 1 single ascending dose human clinical trial of ANAVEX™ 2-73 was successfully completed in healthy human volunteers. It was a randomized, placebo-controlled study. Healthy male volunteers aged 18 to 55 received single, ascending oral doses over the course of the trial. The trial objectives were to define the maximum tolerated dose, assess pharmacokinetics (PK), clinical and lab safety.
- Dosing from 1-60 mg.
- Maximum tolerated dose 55-60 mg; above the equivalent dose shown to have positive effects in mouse models of Alzheimer’s disease.
- Well tolerated below the 55-60 mg dose with only mild adverse events in some volunteers.
- Observed adverse events at doses above the maximum tolerated single dose included headache and dizziness, which were moderate in severity and reversible. These side effects are often seen with drugs that target central nervous system (CNS) conditions, including Alzheimer’s disease.
- No significant changes in blood safety measurements.
- No changes in ECG.
- Favorable PK profile.
- Rapid absorption into blood.
- Dose proportional kinetics.
The trial was conducted in Germany by ABX-CRO in collaboration with the Technical University of Dresden. ABX-CRO and the Technical University of Dresden are well regarded for their experience with clinical trials and CNS compounds.
Human clinical trials
Anavex completed a Phase 2a trial with ANAVEX™ 2-73 in November 2016.
Thereafter, the Company plans to initiate a potentially pivotal 6/12-month Phase 2/3 trial with ANAVEX™ 2-73. This trial is expected to include up to 300 mild-to-moderate Alzheimer’s patients.
Clinical trials are conducted by third-party organizations, not by Anavex directly. Trial participants are selected independently of the company to avoid undue influence.
Note: Individuals seeking information about participating in a clinical trial should contact his/her doctor.