CEO says late-stage buntanetap trial advances toward FDA milestone in bid to slow Alzheimer’s and dementia.
“We think we will be [at that threshold] in March or April.”
Those are the words of Maria Maccecchini, CEO of Malvern-based Annovis Bio, capturing nearly two decades of relentless work in the search for a therapy that could change the lives of people with Alzheimer’s disease. Her company is now on the verge of hitting a crucial Food and Drug Administration (FDA) benchmark that could pave the way for a new drug application for buntanetap, Annovis’s lead therapy.
Halfway there, but every step counts. Annovis is testing buntanetap in 760 patients across the US, each enrolled in an 18-month study. The FDA typically requires results from at least 1,500 patients before it will consider approving a new therapy.
Maccecchini’s comment reflects the company’s confidence that they’ll soon reach that halfway point.
Buntanetap is aiming to do something rare in Alzheimer’s research: not just ease symptoms temporarily, but actually slow the disease’s progression.
“We don’t know what it does at 10 months, 12 months or 18 months. That’s why we are doing the 18-month study,” Maccecchini says, acknowledging the uncertainties inherent in pioneering work [1].
A major checkpoint came when an independent Data and Safety Monitoring Board (DSMB) reviewed six months of data from the trial [2]. Their verdict: no safety concerns. This green light allows the trial to continue uninterrupted. Remarkably, the safety data for Alzheimer’s patients aligns closely with similar results from Parkinson’s patients taking buntanetap, suggesting the therapy could have broader implications for neurodegenerative diseases.
“This response reinforces our confidence in the safety profile of buntanetap,” Maccecchini adds, noting that combined safety data might even streamline future FDA submissions. For patients and families, that’s a signal that the therapy is moving forward responsibly.
Annovis’ progress hasn’t gone unnoticed by investors. When the company shared early results showing buntanetap’s potential benefits, its shares more than doubled in November, jumping excitement in the market. Since then, the stock has settled to a more moderate level, reflecting both cautious optimism and the reality that the therapy is still under study.
Analysts are particularly intrigued because buntanetap may do something few Alzheimer’s treatments have managed: not only ease symptoms like memory lapses or confusion in the short term, but also slow down the underlying progression of the disease itself. In other words, it could help patients function better today while potentially delaying the decline tomorrow.
However, the path is far from over. The first “efficacy readouts” aren’t expected until early 2027. The full picture, capturing how the therapy performs over the entire 18-month study, won’t be available until 2028. While that may feel like a long wait, each milestone along the way offers a potential turning point in Alzheimer’s care.
Longevity.Technology: Alzheimer’s disease erodes independence, dignity and quality of life. For the longevity community, this makes buntanetap’s progress especially significant. Maccecchini’s work moves from reactive care to proactive strategies that tackle the root causes of aging-related decline. Imagine treating Alzheimer’s not just as a late-life inevitability, but as a condition we can intervene on early enough to change its course. That’s the vision driving the field forward.
With the Phase 3 trial already 40% complete and enrollment steadily climbing, Annovis is navigating a high-stakes, high-reward landscape with optimism and caution. The anticipated spring milestone is a symbol of years of effort, and of a possible future where aging doesn’t mean losing yourself to neurodegeneration.
