Markets closed early (1 p.m. EDT) in the United States on Tuesday as part of the celebration of the Independence Day holiday on Wednesday, but that didn’t stop Anavex Life Sciences (NASDAQ:AVXL) from having a booming volume day and spike in share value.
Shares of the New York-based biopharmaceutical company roared ahead 43.6% with nine million shares changing hands in the 3-1/2 hour session following news that the company received approval from the Australian Human Research Ethics Committee to initiate its Phase 2b/3 of ANAVEX2-73 for the treatment of early Alzheimer’s disease.
ANAVEX2-73 acts upon the Sigma-1 receptor protein, for which activation has been shown to decrease key pathophysiological signs of Alzheimer’s, including beta amyloid, hyperphosphorylated tau and increased inflammation. According to Alzheimer’s Disease International, nearly 44 million people worldwide suffer from Alzheimer’s or a related dementia.
The double-blind, randomized (1:1:1), placebo-controlled, 48-week safety and efficacy trial is scheduled to enroll about 450 patients, evaluating two different doses of the drug versus placebo. With the green light in hand, enrollment is expected to be initiated this month.
The trial is an international study, including sites in North America. Primary endpoints will be for safety and cognitive and functional efficacy of ANAVEX2-73. The trial is building upon positive data collected on the therapy during a successfully completed phase 2a study that demonstrated dose-dependent responses in cognition and function in Alzheimer’s patients.
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