Days before World Alzheimer’s Day, which was Saturday, some bad news arrived about the search for a treatment.
Pharmaceutical company Eisai and biotechnology company Biogen announced that they would be discontinuing Phase III clinical studies of the drug elenbecestat for early Alzheimer’s disease.
The two parallel trials are being halted based on the results of a safety review, which found “an unfavorable risk-benefit ratio,” they said. The companies didn’t reveal additional information about the safety issues other than to say that investigators would share details at future medical meetings.
If there were safety issues, then ending the studies is a smart move, of course. But that studies of the drug came this far — a Phase III trial is the phase right before a pharmaceutical company submits a new drug application to the Food and Drug Administration for approval — only to be discontinued surely is disheartening for the many researchers and approximately 2,100 people with mild cognitive impairment or mild Alzheimer’s who were participating.
The clock is ticking, with the number of Americans living with Alzheimer’s expected to increase from 5.8 million today to 14 million by 2050 without a major research breakthrough.
Yet we know that even apparent setbacks such as these can further the research cause and, we hope, move us closer to solutions. So the efforts of researchers and those living with or affected by Alzheimer’s are not in vain.
Lynn Kramer, M.D., chief clinical officer of the Neurology Business Group at Eisai, said as much in the company’s announcement about the ending of the studies.
“Without their contributions, we would not be able to advance Alzheimer’s disease research,” he said. “We are very disappointed with the news and intend to learn from these data and continue engaging with patients and investigators to pursue the discovery of new medicines for Alzheimer’s disease.”
The companies also announced their decision to end a long-term extension of the Phase II clinical trial of elenbecestat.
The drug is an oral beta amyloid cleaving enzyme (BACE) inhibitor, thought to reduce beta amyloid production to potentially slow the progression of Alzheimer’s. According to the Alzheimer’s Association, however, “multiple negative clinical trials targeting BACE … highlights the urgent need to diversify the treatment targets and broaden the therapeutic pipeline for Alzheimer’s and other dementias.”
Fortunately, the association says, “public and private Alzheimer’s research funding is now at unprecedented levels, enabling more diverse and innovative avenues to be explored.” In fact, association officials say they’ve never been so optimistic.
Annual funding for Alzheimer’s research at the National Institutes of Health, for instance, is almost $2.4 billion. The NIH’s National Institute on Aging’s Accelerating Medicine Partnership-Alzheimer’s Disease is working to shorten the time between finding potential targets and drug development and according to the Alzheimer’s Association “has seen dramatic progress in developing web-based tools for the research community and identifying new therapeutic targets for exploration.”
Another reason for hope, according to the association, is the Alzheimer’s Association-funded U.S. Study to Protect Brain Health Through Lifestyle Intervention to Reduce Risk, which is the first study of a multi-component lifestyle interventions to protect cognitive function in a large-scale U.S.-based population.
Let’s take that information and potential good news from Eisai and Biogen — that their studies of the anti-amyloid beta protofibril monoclonal antibody BAN2401 will continue — and let it buoy us, even with the blip of bad news about elenbecestat, as World Alzheimer’s Month continues.