Clinical-stage biopharmaceutical firm Anavex Life Sciences Corp. (AVXL:NASDAQ), which is engaged in the discovery and development of therapeutics for use in treating neurodegenerative, neurodevelopmental, and other central nervous system (CNS) disorders, including Rett syndrome, Alzheimer's disease, and Parkinson's disease, announced Thursday "positive topline results from its Phase 2b/3 ANAVEX®2-73-AD-004 clinical trial of oral ANAVEX®2-73 (blarcamesine) for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD)."
The company advised that during the study, ANAVEX®2-73 successfully met the two predetermined primary endpoints related to cognitive and functional assessment as well as a key secondary endpoint as indicated by a clinical dementia rating-sum of boxes criteria with statistically significant results.
Based upon the data gathered in the trial, it intends to meet with regulatory authorities to discuss the path forward to advancing the use of this medicine in Asia-Pacific, Europe, and the U.S.
The company explained that "ANAVEX®2-73 (blarcamesine) is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors."
During several preclinical and clinical in-human studies, ANAVEX®2-73 has demonstrated strong potential for use in halting and reversing the progression of Alzheimer's disease. In addition, in animal studies, ANAVEX®2-73 has been shown to exhibit anti-amnesic, anticonvulsant, anti-depressant, and neuroprotective properties and shows promise for treating multiple CNS disorders such as epilepsy.
The multicenter, double-blind Phase 2b/3 ANAVEX®2-73-AD-004 study enrolled a total of 509 patients diagnosed with early AD who were randomized to receive either a low or high dose of ANAVEX®2-73 or a placebo over a period of 48 weeks. The company also plans to initiate an open-label extension study designed to monitor participants for a period of 96 weeks.
AVXL shares opened almost 42% higher Friday at US$12.57 (+US$3.70, +41.71%) over Thursday's US$8.87 closing price.
The company highlighted that during the trial, AD patients treated with ANAVEX®2-73 exhibited visible improvement and were 84% more likely to have improved cognition and were 167% more likely to improve function versus patients given a placebo.
The firm mentioned that these results demonstrate robust and clinically meaningful improved outcomes in both cognition and function from baseline. In addition, the company listed that ANAVEX®2-73 produced statistically significant reductions in the cognitive decline of 45% compared to the control group.
A/Professor Stephen Macfarlane, FRANZCP, Head of Clinical Services at the Dementia Centre, HammondCare, and Principal Investigator, stated, "People living with Alzheimer's disease desperately need new therapies, and I am truly impressed with the outcome of this study, which demonstrated reversal of cognitive decline . . . These results complement and are consistent with findings from the previously completed Alzheimer's disease Phase 2a ANAVEX®2-73 trial, which also demonstrated therapeutic effect on cognition and function."
The company's Chief Medical Officer Edward R. Hammond, M.D., Ph.D., M.P.H. stated, "We are very pleased to see such positive clinical data in patients with Alzheimer's disease, which is otherwise a progressive disease . . . We intend to discuss these findings with regulatory authorities in the context of the ongoing clinical development of ANAVEX®2-73 in this indication, with the goal of providing much-needed treatment to the millions of patients living with Alzheimer's disease."
Anavex Life Sciences' President and CEO Christopher U. Missling, Ph.D. commented, "These clinical study findings confirm the robustness of the ANAVEX precision medicine platform, and we look forward to advancing ANAVEX®2-73 as a potential new treatment option for Alzheimer's disease while we continue to focus on the effect of ANAVEX®2-73 leveraging this approach to drug development to provide intelligent solutions beyond many traditional neurology trials in disease areas with high unmet needs."
The firm noted that AD is the number one cause of dementia and the fifth-highest cause of death in people over 65. In 2020, about US$305 billion was spent on treating and caring for those afflicted with AD. This amount is expected to more than triple in the coming years as the population ages.
Anavex is a biopharmaceutical firm headquartered in New York, N.Y., that is working to create and develop novel therapeutics to treat neurodegenerative and neurodevelopmental disorders, pain, and various types of cancer. The company is highly focused on developing medicines for use in the treatment of central nervous system (CNS) diseases such as Alzheimer's, Parkinson's, and Rett syndrome. The firm advised that "its leading drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a 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 with Rett syndrome."
AVXL shares opened almost 42% higher Friday at US$12.57 (+US$3.70, +41.71%) over Thursday's US$8.87 closing price.
Anavex Life Sciences Corp. started this morning with a market cap of around US$939.44 million with approximately 77.96 million shares outstanding. The stock trades in the 52-week range between US$7.13 and US$20.24 and today between US$10.66 and US$13.23 per share.
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