Biogen Inc. BIIB announced that a new phase III study has been initiated to evaluate its and Eisai’s, the company’s Japan-based partner, anti-amyloid beta monoclonal antibody, BAN2401 to treat preclinical (asymptomatic) Alzheimer’s disease. The phase III study, AHEAD 3-45, to be conducted as a public-private partnership between The Alzheimer's Clinical Trials Consortium (ACTC) and Eisai, has been initiated in the United States. Around 1400 participants will be enrolled in the AHEAD 3-45 study. The study will be conducted in the United States, Japan, Canada, Australia, Singapore, and Europe.
Amyloid is a protein that forms plaques in the brains of people with Alzheimer’s. BAN2401 is being investigated to see whether it can slow the progression of memory problems associated with amyloid. At present, a pivotal phase III study is being conducted on BAN2401 by Biogen/Eisai in symptomatic early AD. The AHEAD 3-45 study is being conducted on asymptomatic patients i.e. those who are clinically normal but have intermediate or elevated levels of amyloid in their brain. If such patients can be treated with anti-amyloid therapy like BAN2401 at the correct time, it can prevent future cognitive decline in such patients.
Biogen’s shares have declined 6.8% against the industry’s increase of 6.6% in the same time frame.
Biogen is a key player in the Alzheimer’s disease therapeutic area. Last week, it completed submission of the biologics license application (BLA) to the FDA seeking approval of aducanumab, its controversial investigational treatment for Alzheimer’s disease.
The FDA will now decide within 60 days whether to accept the application for review and also grant its priority review status, if accepted.
Alzheimer’s, a fatal condition that causes progressive decline in memory, has always been a highly challenging area, and not much progress has been made despite significant investments (both funds and resources). The drugs presently available just treat the symptoms of the disease. Several companies have failed to develop safe and effective treatment options to treat this deadly brain disease. Other than Biogen, several large pharma companies, including Roche RHHBY, Amgen AMGN, Novartis NVS, Merck, Pfizer, Lilly and AstraZeneca stopped development of their AD candidates in the last few years either due to low possibility of success or safety concerns.
Despite the setbacks, the companies continue to invest heavily in developing AD treatments, given the high commercial potential in this market. Success in this area means huge returns. This is because more than 5 million Americans are living with AD with the numbers expected to triple by 2050 (Data: Alzheimer's Association). The market has immense commercial potential and companies coming out with new treatments could rake in billions of dollars in sales
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
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