TrueBinding EAP Program Makes Treatment Available to Alzheimer’s Patients & it’s Making a Difference

Less than six months ago, Alzheimer’s Disease drug candidate TB006 made news when results from a phase 2a clinical trial for the treatment showed that it not only could slow the progression of the disease like other treatments on the market, but that it could also improve cognition and function with little to no side effects, in those with moderate to severe forms of the disease after just one month of treatment. The team at TrueBinding, Inc.— where TB006 is currently being developed and tested— made news again when their followup Open Label Extension (OLE) study not only confirmed results from the clinical trial, but also showed that 47 percent of participants who completed a three-month treatment program showed signs of disease reversal or other cognitive improvements.

This gave the team the evidence needed to move forward with plans to seek FDA approval for the treatment. But the drug approval timeline is long, and researchers realized that patients currently benefitting from TB006 might not have access to the drug again until its approval. This is particularly true for patients whose disease progresses to moderate or severe Alzheimer’s, which can preclude them from participating in ongoing clinical trials. That’s why TrueBinding sought— and was granted— authorization for an Expanded Access Program (EAP), an FDA-supported program that allows compassionate use of drugs that have not yet achieved FDA approval but that can significantly improve the lives of patients with serious diseases or conditions, and for which there is no comparable alternative.

“What we learned during our phase 2a clinical trial, and our open label extension study was that TB006 has the potential to help patients with moderate to severe Alzheimer’s,” said George Hong, CEO and Co-Founder of TrueBinding.

“Our data point to a trend of disease reversal, and involved doctors, patients, and caregivers have anecdotally expressed a remarkable change in quality of life and cognition for those who have received treatment. Our goal is to ensure that while we continue the very important FDA approval process for TB006 that those who need help now can access it. That’s why we sought expanded access program authorization.”

Dr. William Gael is founder/director of The Gael Center in New York City and a boad-certified physician whose patients have benefitted from treatment with TB006. Prior to the launch of TrueBinding’s EAP, two of Dr. Gael’s patients were involved in a clinical trial and the OLE study for the treatment. When the EAP became available, it made sense to support patients in gaining access to the TB006 because according to Dr. Gael, the benefits outweigh the risks.

“When evaluating any treatment, a doctor must weigh the benefits versus the risks. I have encouraged eligible patients to become a part of the TB006 expanded access program because, in this case there’s next to no risk and there’s an incredible amount of benefit. In fact, I have never seen such an unbalanced ratio of benefit to risk in favor of benefits.”

Dr. Gael has been practicing medicine for 33 years, and intermittently treating patients with Alzheimer’s Disease for nearly the same amount of time. He has witnessed the positive impacts of TB006 on multiple patients accessing the treatment. “I have personally witnessed TB006 not only halt disease progression but reverse it… without any serious or adverse effects. I have never seen that in another study or trial,” he said, adding that his patients have gotten their lives back in ways that most people take for granted.

“One of my clients who always repeated the same statement over and over now speaks with perfect clarity, and told me that after being treated with TB006, how clearly they’re now able to think. Another can now drive to the grocery store, get groceries, come home, and make dinner… things he could not do before.”

And while Dr. Gael has seen the early signs of Alzheimer’s Disease manifest clinically as agitation, restlessness, aggressive verbal or physical behavior, confusion, inappropriate behaviors, and repetitive questions or statements in many patients over the years, both the disease and the hope that comes with TB006 hit close to home. “The problem of dementia has been a bit personal for me because my father died of dementia eight years ago, and my 91-year-old mother is presently living with dementia,” he said.