FOSTER CITY, Calif., March 28, 2023 /PRNewswire/ — TrueBinding, Inc.— a clinical-stage biotherapeutic company creating new and exciting molecules for applications in neurodegenerative and other disease areas with great unmet needs— today announced early results from an Open-Label Extension (OLE) study for the use of its TB006 drug in the treatment of Alzheimer’s Disease. The early results indicate the potential for the reversal of disease progression and sustained clinical benefits beyond the drug’s phase 2a clinical trial success.
“The one-month treatment of Alzheimer’s Disease with TB006 in the blinded phase 2a trial yielded strong clinical data pointing to a trend of disease reversal in moderate to severe cases, but Alzheimer’s Disease is a chronic disease, so some people may require longer treatment to show improvement,” said Dr. Dongxu Sun, Ph.D., Chief Executive Officer of TrueBinding and an expert in the development of novel drugs, adding that this was one of the primary motivations behind the OLE study. “A significant number of participants in the OLE study, including those with severe Alzheimer’s Disease, have shown disease reversal or stabilization after only three months of treatment, and without significant adverse events.”
Among 79 participants who completed a three-month treatment in the OLE study, 47 percent showed signs of disease reversal or cognitive improvement and 28 percent showed disease stabilization. This means that the majority of participants experienced a positive response. This is a significant improvement over results from other treatments currently on the market for Alzheimer’s Disease. According to Sun, Lecanemab— a treatment not affiliated with TrueBinding— which received accelerated approval from the FDA in January 2023, showed zero signs of disease reversal or improvement after 18 months of treatment. TB006’s outcomes suggest that the drug may be an effective treatment option for Alzheimer’s Disease beyond what is currently available.
The OLE study expands upon the work already completed in clinical trials. Results from TrueBinding’s phase 2a clinical trial were released in November 2022. The results of that study indicated that the drug improved cognition and function in study participants with moderate to severe Alzheimer’s Disease with little to no side effects.
This prompted the science team to initiate an OLE study to pursue additional data on the drug’s long-term benefits and safety profile. “The biggest benefit to an Open-Label Extension study is obtaining long-term safety data,” said Sun. “And it is our hope that a longer treatment in the OLE will yield strong, sustained clinical benefits.”
The uncontrolled OLE study commenced in September 2022 and will follow participants for up to two years to collect and report on general observations. TrueBinding will also soon commence a phase 2b study, which will collect and analyze additional clinical data over the course of a full year. Sun said that the company hopes and expects that the OLE study results and the phase 2b clinical trial “will reveal more about the potential for use of TB006 in treating Alzheimer’s Disease.”
TrueBinding will attend a Type B End-of-Phase 2 meeting with the FDA in April 2023 to discuss the results of the phase 2a clinical trial and updated results from the OLE study, and the potential for a rapid development pathway for TB006.
TB006 is a humanized monoclonal antibody that, by blocking Galectin-3, the root cause of neuroinflammation and aggregation of Aβ and pTau and other pathogenic factors, has the potential to improve cognition and functioning of patients with Alzheimer’s disease (AD). In AD in vivo model studies, TB006 showed promising capabilities in significant reduction of the aggregation of Aβ/Tau proteins and neuroinflammation, and significant improvement of cognitive performance. In a Phase 1b/2a proof-of-concept trial in mild to severe AD patients, TB006 demonstrated great improvements in cognition and functioning. TB006 is currently being evaluated in a Phase 2 open-label extension trial in patients with AD and in a Phase 2 trial in patients with acute ischemic stroke.
About TrueBinding, Inc.
TrueBinding Inc. is a clinical-stage biotherapeutics company focused on pioneering the development of innovative monoclonal antibodies for the treatment of some of the most challenging neurodegenerative diseases, including Alzheimer’s disease (AD), as well as stroke, oncology and other serious diseases. For more information, visit www.truebinding.com.
SOURCE TrueBinding, Inc.