Biopharmaceutical company Anavex Life Sciences Corp. recently presented encouraging results from their phase 1 clinical trial, a study testing the company’s lead investigational oral treatment for Alzheimer’s disease, Anavex 2-73, at CNS Summit 2014 in Boca Raton, Florida. After assessing the drug’s safety and effectiveness, the medication is expected to be able to prevent, halt, and/or reverse the course of the disease. The company is now planning phase 2a trial of ANAVEX 2-73, as well as ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept).
The phase 1 clinical trial demonstrated that the treatment is safe and well tolerated, suggesting a favorable pharmacokinetics profile. In addition, the randomized, double-blind, placebo-controlled study demonstrated that no severe adverse events were registered. Some of the adverse events reported include moderate and reversible headache and dizziness, which are common symptoms associated with drugs that target central nervous system (CNS) conditions, such as Alzheimer’s.
“We are extremely encouraged by the strong safety profile of ANAVEX 2-73 as evidenced by the Phase 1 trial data. Treatment of Alzheimer’s disease generally requires ongoing drug administration, which underscores the importance for any potential new drug to have a low side effect profile,” said the president and chief executive officer of Anavex, Christopher U. Missling, PhD. “Following recent regulatory approval to start a Phase 2a efficacy study of ANAVEX 2-73 in Alzheimer’s patients, we are excited to advance our investigational compound as a potential treatment option for this devastating disease with high unmet medical needs.”
Results of the trial were presented in a poster session entitled “A Phase 1 Dose Escalation Study to Investigate Safety, Tolerability, and Pharmacokinetics of ANAVEX 2-73 in Healthy Male Subjects,” presented by Ole Voges and Ingo Weigmann of ABX-CRO, Norman Bitterlich of Medizin & Service GmbH, Christoph Schindler of Clinical Research Center, and Christopher U. Missling, President and CEO of Anavex. The study included 22 healthy male volunteers who were administrated with single, ascending oral doses of ANAVEX 2-73 between 1 mg and 60 mg.
In addition to assessing the safety of the medication, the study also demonstrated that its maximum tolerated dose is 55mg, and it was defined as suitable for daily oral dosing based on its PK profile. ANAVEX 2-73 is an orally available small molecule that had already been approved at the beginning of the month for phase 2 trials by the Ethics Committee in Australia.