Anavex Life Sciences Corp. (NASDAQ: AVXL) has provided a regulatory update on its drug candidate, Blarcamesine, for early Alzheimer's disease. The company received a negative trend vote on the marketing authorization application (MAA) for Blarcamesine from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) following its CHMP oral explanation. Anavex plans to request a re-examination of the CHMP opinion upon its formal adoption, including providing relevant biomarker data based on feedback and continued guidance from the CHMP, EMA, and the Alzheimer’s disease community.
The U.S. FDA’s Center for Drug Evaluation and Research (CDER) advised Anavex to request a meeting to discuss the company’s Alzheimer's disease clinical trial results.
Anavex's lead drug candidate, Anavex®2-73 (Blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome.
Anavex®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting sigmar1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. Anavex®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy.
In addition, Anavex believes that Anavex®3-71, which targets sigmar1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xtg-ad) mice, including cognitive deficits, amyloid, and tau pathologies.
The company is committed to continuing to work in partnership with global regulatory bodies in order to advance science and potentially new treatment options for patients and their families.
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. As a result of these announcements, the company's shares have moved -17.54% on the market, and are now trading at a price of $5.69. Check out the company's full 8-K submission here.
