Pint-Sized Anavex May Soon Have the Data to Prove Biogen and Eli Lilly's Alzheimer's Approach is All Wrong
December 8, 2015
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Anavex Life Sciences is betting other drug companies have it all wrong when it comes to potential Alzheimer’s disease treatments, which helped drive company stock to a one-year high of $14.89 per share last month.
There is a widespread belief that the buildup of amyloid plaque in the brain is one of the primary causes of the disease, with several companies, including Biogen, Inc. , Eli Lilly and Company and Genentech , following that research avenue. But, New York-based Anavex is banking on major pharmaceutical companies being wrong about the causes of Alzheimer’s disease. Company research is not following the amyloid path, but focusing on oxidation and nitration in the brain. Cory Renauer, a Motley Fool columnist, said amyloid is not neurotoxic as many researchers have believed. Researchers, he said, “have shifted from the notion that oligomers not plaques are the neurotoxic species. Plaques that end up in the walls of blood vessels may be a problem. The zinc that plays a role in the formation of amyloid oligomers along with copper increase hydrogen peroxide early in Alzheimer's disease and this too can damage the brain. But both problems can be dealt with through the use of specific chelating antioxidants.”
It is because of that statement Renauer touts the research being done by Anavex. The company’s lead product is Anavex 2-73, an oral treatment being developed to “modify” Alzheimer’s disease, rather than treat it. The drug candidate “inhibits oxidation, nitration and cell death by inhibiting the cascade which follows NMDA receptor over-activation,” a Seeking Alpha report said. Mouse models have shown positive effects in treating the dementia disease, the company said. A recent Phase I clinical trial determined safe dosage levels and results from a Phase II trial are expected to provide greater efficacy data. If the data is strong, company stock could soar, Renauer said. Anavex is currently trading at $6.46 per share.
Alzheimer's disease, a type of dementia, affects 15 million people worldwide, a number that is expected to grow to 75 million by 2030 due, in part, to the lack of effective treatments. In total, there are about 50 million people suffering from some form of dementia worldwide. There are currently no drugs that target the cause of Alzheimer’s the most common form of dementia. There are several drugs on the market that help manage Alzheimer’s, but none treat the primary cause, including Eisai Inc.’s Aracept. According to a Bloomberg report, there have been more than 100 failed efforts to develop a treatment for Alzheimer’s disease since 1998, including two from Roche. A 2014 report in Alzheimer’s Research UK showed 244 Alzheimer’s drugs were tested between 2002 and 2012, but only one was approved—Lundbeck A/S ’s Ebixa, Bidness Etc. reported.
In April, Biogen announced its drug BIIB037, or aducanumab, led to reductions in brain amyloid plaque by as much as 71 percent. The plaque reduction was more pronounced as the dose of the drug increased and over time and Biogen also announced the drug was able to reduce cognitive decline. Eli Lilly’s solanezumab targets the amyloid plaque and Phase III results are expected soon.
In September, Amgen and Novartis struck a collaborative deal to co-develop amyloid plaque treatments for Alzheimer's disease. The agreement will combine each company’s BACE (beta-site APP-cleaving enzyme-1) programs that target amyloid plaque buildup in hopes of preventing Alzheimer's. Novartis' CNP520 is an oral drug designed to prevent the production of different forms of amyloid and has the potential to prevent, slow or delay the symptoms associated with Alzheimer's disease.
Genentech , a division of Roche , is currently running an Alzheimer’s study in Colombia, spurred on in part by Biogen’s early successes with BIIB037. Genentech’s Colombian trial involves approximately 300 people, with about 200 being suspected of carrying a rare gene that leads to early onset dementia by age 45.