Pharmaceutical company Biogen and its Japanese partner Eisai Co. have ended two global phase 3 trials testing the Alzheimer’s drug aducanumab due to the fact that the drug was not going to meet the primary endpoint.
An independent data-monitoring committee determined that aducanumab was not likely to benefit to Alzheimer’s patients as compared to a placebo, crushing the hopes of researchers looking for a cure for the degenerative disease. No safety issues associated with the drug were discovered.
According to Biogen CEO Michel Vounatsos, “This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience. We are incredibly grateful to all the Alzheimer’s disease patients, their families and the investigators who participated in the trials and contributed greatly to this research.”
As Jared Holz, a healthcare analyst at Jefferies, said, “This was the largest opportunity and the most high-profile pipeline event for trial events in the entire space, you could argue, let alone for Biogen. We’ve been talking about this for several years with an expectation we’d get a readout in 2020. There was obviously a chance you could have a futility analysis in 2019, but investors thought we were past that point.”
Aducanumab was supposed to decelerate cognitive decline and functional impairment in people who had mild Alzheimer’s disease by removing amyloid from the brain. Researchers believe that amyloid protein promotes Alzheimer’s-related decline by forming sticky plaques in the brain, possibly interfering with the function of nerve cells and causing dementia and memory loss. Because the trials failed, researchers are questioning the amyloid hypothesis and possible treatment path.
The failure of the clinical trial marks another setback in the quest for a drug to combat Alzheimer’s disease. In recent years there have been many such failures . In 2018 alone, pharma giants such as Eli Lilly, AstraZeneca, Pfizer and Merck stopped research or development into potential Alzheimer’s and dementia therapies because of disappointing results. Between 1998 and 2017, 146 drugs that aimed to solve Alzheimer’s disease failed. During that timeframe, only four Alzheimer’s disease drugs were able to garner approval from the U.S. Food and Drug Administration (FDA).
Aducanumab appeared to be promising enough for Goldman Sachs analysts to predict that its sales could reach $12 billion, according to CNBC. Shares in Biogen tumbled 28 percent after the news. Biogen, one of the world’s largest biotech companies, has a market value of $63 billion. With Biogen out of the picture, analysts speculate that experimental drugs being developed by Avanir Pharmaceuticals, Axsome Therapeutics, Amgen and Novartis could emerge as key candidates in the fight against Alzheimer’s.
Vounatsos concluded, “Biogen’s history has been based on pioneering innovation, learning from successes and setbacks. Driven by our steadfast commitment to patients and our strong business foundation, we will continue advancing our pipeline of potential therapies in Alzheimer’s disease and innovative medicines for patients suffering from diseases of high unmet need.”