Right now, human clinical trials and an Expanded Access Program (EAP) are underway for TB006, an investigational medication for the treatment of Alzheimer’s Disease developed by TrueBinding, Inc. While it’s not the only treatment for Alzheimer’s currently in the spotlight, there’s something different about TB006. Unlike other investigational treatments for Alzheimer’s, and even unlike those that have received accelerated approval from the Food & Drug Administration (FDA), TB006 doesn’t just slow the progression of the disease. Results from clinical trials have shown a trend towards reversal of symptoms. And it’s happening without significant side effects. That means patients are getting better without sacrificing their health. And when it comes to aging, health is the most important thing we have.
The serious business of healthy aging
According to the U.S. Census Bureau, just over a decade from now there will be more older adults in the United States than children for the first time. By 2034, there will be more than 77 million Americans over the age of 65, and by 2060, the 65+ crowd will have grown to more than 94.7 million people. The closer we get to this demographic flip, the higher the demand for healthcare, assisted living and retirement communities, in-home care, and resources and opportunities to age healthfully. Aging healthfully means eating right, exercising, and keeping up a social calendar, but with an increasingly older population, it also means something just a little bit more: early and regular screening for Alzheimer’s Disease.
Why we need early and regular screening for Alzheimer’s Disease
Alzheimer’s Disease is the most common cause of dementia and is believed to result from the buildup of reactive proteins around brain cells, which ultimately leads to inflammation and cellular damage. Typically, a person’s first screening for Alzheimer’s Disease happens after symptoms first appear, which for most people happens around or after age 65. But the damaging effects of Alzheimer’s Disease can begin 10 to 15 years before those symptoms become apparent. While there’s no FDA-approved cure for Alzheimer’s Disease today, early detection ensures that patients with Alzheimer’s receive access as soon as possible to information, proper care, and support, and have the time needed to adjust to inevitable changes in their cognition, motor function, personality, memory, and mood that come with the disease over time. Alzheimer’s Disease progresses slowly, and early and regular screenings can make all the difference in quality of life. And if there’s one key takeaway here it’s that we all have to take control of our health and talk to our medical providers earlier and often.
How the medical industry is changing the future of Alzheimer’s Disease
This year— 2023— has been hailed as the year of Alzheimer’s Disease treatments. In January, the FDA awarded accelerated approval to lecanemab, an investigational treatment for Alzheimer’s Disease that targets disease progression in individuals with early to moderate Alzheimer’s, aiming to slow it down. Shortly thereafter, donanemab, another treatment with similar focus on slowing cognitive decline from one stage of disease to the next, completed a promising clinical trial. Importantly, both of these investigational treatments come with serious side effects. Those side effects may include headaches, microbleeds in the brain, and swelling of the brain. Despite that, these drugs have both shown the potential to slow the progression of dementia associated with Alzheimer’s Disease, although ultimately, the disease will still progress to its end. And they’re not able to reverse the disease, either. But there is still hope.
TB006 could permanently change how we age
This all brings us back to TrueBinding, Inc. and TB006. In April 2023, TB006 made headlines when results from the treatment’s phase 2a clinical trials showed that the drug was improving cognition and function in patients with moderate to severe Alzheimer’s Disease, something that wasn’t happening with other treatments. But the clinical trial was just one month long. Researchers at TrueBinding believed that a longer period of treatment could yield more significant results and launched an Open Label Extension (OLE) study to prove it. After just three months of treatment, 47 percent of participants showed signs of disease reversal and an additional 28 percent, including those with severe Alzheimer’s Disease, showed signs of disease stabilization. What’s more, it did that without any serious side effects. An upcoming phase 2b clinical trial will collect and analyze treatment data over the course of a full year. If the data continues to trend towards reversal, it could put TB006 on the path to accelerated approval. But researchers know that not everyone qualifies for a clinical trial. In fact, once Alzheimer’s Disease has progressed to moderate to severe levels, it can be quite difficult to qualify for a clinical trial, even those targeting these stages of disease. That’s why the company was granted FDA approval to launch an Expanded Access Program (EAP), which creates a pathway for compassionate access to the treatment for patients with severe forms of the illness, even though the drug isn’t yet FDA approved.
What it all means is that there is an investigational treatment now that has the potential to not only slow down the progression of Alzheimer’s, but also stop it completely, and reverse the effects. If soon available to the public, this type of breakthrough would not only redefine aging healthfully, but also give us all more opportunities to age gracefully and independently.
George M. Haig
George M. Haig, PharmD is Clinical Lead of TrueBinding, LLC.
