Anavex Life Sciences Corp. today announced screening of the first healthy volunteers for the Phase I clinical study of ANAVEX 2-73, its lead compound for the treatment of Alzheimer’s disease. ANAVEX 2-73 is the first of a new class of wholly-owned, oral, disease-modifying compounds, which act through sigma-1 receptor agonist as well as muscarinic cholinergic effects and up-regulation of Bcl-2.
ANAVEX 2-73 also modulates endoplasmic reticulum stress and triggers a series of intracellular effects thought to modify ion channel signalling at the mitochondrial level. In pre-clinical studies, ANAVEX 2-73 and its only and active metabolite, ANAVEX 19-144, alleviated neurotoxicity and cognition deficits associated with Alzheimer’s disease in animals. Toxicity studies in mice, rats and dogs showed a favorable safety profile.
The Phase I trial, in at least 16 healthy volunteers, is a randomized, placebo-controlled, dose-escalating study designed to assess the safety, tolerability and pharmacokinetics of oral ANAVEX 2-73 and will help determine the maximally tolerated dose in humans. The study is being carried out in collaboration with ABX-CRO, which has conducted various Alzheimer’s disease studies, and the University of Dresden in Germany.
“We are excited that the first human study for ANAVEX 2-73 is underway. ANAVEX 2-73 has been more than a decade in the making, so this event marks a great milestone for our company,” said Dr. Cameron Durrant, Executive Chairman of Anavex.
About Alzheimer’s Disease
While Alzheimer’s disease is most common in people over the age of 65, it can strike adults of any age irrespective of their gender, background or socioeconomic status. According to the Alzheimer’s Association, an estimated 5.4 million Americans are currently living with Alzheimer’s disease. The number of Americans aged 65 and over with Alzheimer’s is estimated to reach 7.7 million in 2030. This represents a 50 percent increase from the 5.2 million Americans aged 65 and older who are currently affected. The Alzheimer’s Association further projects that the number of Americans aged 65 and older who are affected by Alzheimer’s disease may triple to between 11 and 16 million by 2050 unless there are developments to prevent or more effectively treat the disease.
About ANAVEX 2-73
ANAVEX 2-73 is the first of a new class of oral, disease-modifying drugs being studied to potentially treat Alzheimer’s disease itself, versus treating its symptoms.
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