The recent announcement that Merck is halting a Phase II/III study for a promising Alzheimer's treatment (verubecestat) was another setback in the continued and intensive effort to deliver an innovative therapy by 2020. UsAgainstAlzheimer's, which works collaboratively with industry partners to see near- and long-term progress against this destructive disease, applauds the vast investment of Merck, the diligence of the many principal investigators involved in the study and the courage of the clinical trial participants, as well as their caregivers, for their deep commitment to the fight.
"The spirited work of Merck and other drug companies that are concentrating vast resources into a cure for Alzheimer's is not underappreciated. Each outcome, while assuredly disheartening, builds our knowledge and leads us closer to a solution for the millions of people with Alzheimer's or related dementias," said UsAgainstAlzheimer's Co-Founder and Chairman George Vradenburg. "Just as we have before, we will keep working incessantly, passionately and strategically so that the next round in this fight goes to us."
Similar to Eli Lilly's recent negative Phase III trial of the once-promising therapy solanezumab, verubecestat was assessed by an oversight committee as having "virtually no chance of finding a positive clinical effect" on people with mild to moderate symptoms. Verubecestat, like other drugs in the pipeline, targets the beta amyloid protein that forms most of the plaque that builds up in the brains of Alzheimer's patient.
"The drug will continue to be studied on people with a very early form of Alzheimer's disease where we are hopeful for a better outcome," Vradenburg said.
Following the solanezumab news, Vradenburg issued a letter, acknowledging lessons learned in the aftermath of negative trials and providing a blueprint for moving forward on the path to a cure. His guidance, directed at policymakers, advocates and researchers, rings true following the verubecestat news. It includes these pivotal next steps:
- Obtaining a minimum of $2 billion in annual U.S. federal funding for Alzheimer's research, with an insistence that, in the near future, every government in the world provide funding equivalent to one percent of their Alzheimer's care costs (which, in the United States would equal $2.3 billion, according to 2016 figures).
- Calling upon President Trump to exercise global leadership in this effort.
- Building a high-speed specialized Alzheimer's trial network to enable the more rapid and efficient testing of therapies.
- Utilizing "big data" to enable doctors to detect Alzheimer's disease at the earliest possible moment when prevention therapies now in testing could have their greatest effect.
- Achieving greater racial, income and educational diversity among clinical trial participants, realizing that, by 2030, a majority of Americans with Alzheimer's are expected to be members of what are today called "minority" populations.
Despite the recent news, there is hope, as there are more promising innovations on the horizon. An analysis of the Phase III Alzheimer's drug pipeline, conducted by ResearchersAgainstAlzheimer's (RA2), shows that there are now 21 Alzheimer's drugs in Phase III clinical trials, 19 of which may be on track to launch in the next five years. In addition, RA2 reports that 10 drugs are scheduled to have trial completion dates in 2017 and 2018.
"UsAgainstAlzheimer's was founded because we wanted to turn the pain we experienced with this disease to drive our shared purpose to boldly break down the barriers to a cure," Vradenburg said. "We are grateful to the researchers and clinical trial participants, as well as the enormous financial contributions of Merck and other industry leaders, who have a similar passion to eradicate this disease."
UsAgainstAlzheimer's is an innovative non-profit organization demanding - and delivering - a solution to Alzheimer's. Driven by the suffering of millions of families, UsAgainstAlzheimer's presses for greater urgency from government, industry and the scientific community in the quest for an Alzheimer's cure - accomplishing this through effective leadership, collaborative advocacy, and strategic investments.
Founded in 2010, UsAgainstAlzheimer's has worked across sectors to: (1) secure the national goal of preventing and effectively treating Alzheimer's by 2025 and help secure nearly $500 million in additional public funding for Alzheimer's research over the past few years; (2) drive global efforts that resulted in the leaders of the world's most powerful nations, the G7 group, to embrace a similar 2025 goal and to call for greater levels of research investment and collaboration; and (3) forge industry commitments to improve efficiencies for an expedited drug discovery and approval process.