A serious form of dementia, Alzheimer’s Disease progresses slowly. Over time, it robs those affected of their memories, cognition, motor skills and self-management. It takes, quite literally, everything, and not just from those with the disease. According to the Centers for Disease Control & Prevention (CDC), more than 5.8 million Americans are living with Alzheimer’s; their friends and family are left to watch the outcome. Although treatments are available to slow the progression of Alzheimer’s, there is currently no approved cure. But thanks to a team of researchers at Foster City, Calif.-based TrueBinding, Inc., that may change someday quite soon.
Researchers believe that Alzheimer’s Disease starts with the buildup of reactive proteins around brain cells. This results in a cascading effect characterized by inflammation, cellular damage, and decreased cognitive function. Most drugs targeting Alzheimer’s Disease focus on slowing its progression. In July 2023, lecanemab, an amyloid beta-directed antibody, received FDA approval for individuals with mild dementia or cognitive impairment due to Alzheimer’s disease and confirmed elevated beta-amyloid in the brain. Earlier this year, a successful clinical trial was completed for donanemab, another potential treatment for Alzheimer’s Disease that focuses on slowing cognitive decline. While both drugs represent a remarkable step forward in slowing the progression of Alzheimer’s, they’re both also associated with undesirable and sometimes serious side effects, including brain bleeds and swelling. These drugs also have no impact on disease reversal, meaning that while these drugs slow down the progression of Alzheimer’s Disease, they do not put a stop to it and are not able to reverse the damage already caused.
Enter TB006— TrueBinding’s candidate treatment focused on both slowing and reversing the effects of Alzheimer’s Disease. Although the treatment has not yet completed clinical trials, results thus far are spreading hope amongst doctors, researchers, Alzheimer’s patients, and their families. In April 2023, results from the TB006 Phase 2a clinical trial indicated that the drug could, in fact, improve brain function and cognition in patients living with moderate to severe Alzheimer’s Disease. What’s more, participants in the clinical trial experienced little to no side effects. Because the clinical trial lasted for just one month, TrueBinding’s research team launched an Open Label Extension (OLE) study, both to generate more evidence and to give participants more time and additional access to TB006.
George M. Haig, PharmD and Clinical Lead at TrueBinding expressed of the results, “The one-month clinical trial for TB006 clearly pointed to a trend of disease reversal in both moderate and severe cases of Alzheimer’s, but this is a chronic disease, and we knew at the time that one month of treatment may not be enough to create lasting improvements, particularly for those patients who are suffering from the most severe cases of Alzheimer’s. We wanted to help those people, and the OLE study has confirmed that we can. After three additional months of treatment, roughly 47-percent of the participants in that study showed signs of disease reversal or cognitive improvement. Simply put, they were getting better. Also, in both studies, we saw few, if any side effects, and certainly not the very serious side effects typically associated with treatments for Alzheimer’s Disease. For us, this is a “eureka” moment, and for Alzheimer’s patients and their families, it’s potentially a sudden light at the end of what has been a very long, dark tunnel.”
TB006 still has a long way to go before it is approved for broad use in treating Alzheimer’s Disease. In the meantime, the treatment is available via an Expanded Access Program (EAP). EAPs are a pathway for patients with serious illnesses like Alzheimer’s to access some investigational medications without having to qualify for a clinical trial. That means TB006 is continuing to help patients and their loved ones right now.
Denise Womble’s husband has Alzheimer’s Disease and participated in the Phase 2a clinical trial for TB006. Like other patients with Alzheimer’s, Denise’s husband couldn’t remember her name, and was unable to dial their daughter’s telephone number. He was also suffering with speech difficulties and was noticeably not the man his family knew and loved.
In emails to the TrueBinding scientific team that she agreed to share with the media, Denise expressed the ray of hope that came almost immediately during the trial, “Post-infusion, [my husband] was able to remember my name, and dialed our daughter’s number on the phone with ease,” adding that at the end of the month, “Our son mentioned that he could see a large improvement in his father’s speech and confidence.”
If the results, along with the Wombles and the dozens of other families with similar stories of disease reversal are any indication, TB006 isn’t just another treatment for Alzheimer’s Disease. It’s a way to take back everything it has stolen.
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