New Hope For Dementia Including Alzheimer’s Disease
Lead drug TB006 received FDA approval in 2023 for an Expanded Access Program, allowing early access to this promising investigational treatment, and was renewed in 2024 and 2025.
Revolutionizing Patient Care
TrueBinding is optimizing patient care through its revolutionary pipeline of monoclonal antibody therapeutics, providing targeted treatments for a diverse range of diseases and medical conditions. By harnessing the power of our proprietary platform technology, we rapidly develop and deliver highly specific and effective monoclonal antibodies—ushering in a new era of precision medicine that holds the promise of improved patient outcomes and enhanced therapeutic options.
As part of our commitment to expanding access to innovative treatments, TrueBinding received FDA approval in 2023 for an Expanded Access Program (EAP) under an Intermediate-Size Patient Protocol—the only one of its kind approved that year. This program, renewed in 2024 and 2025, enables eligible patients with serious or life-threatening conditions to access promising investigational therapies when no comparable alternatives exist.
Through bold innovation and patient-focused development, TrueBinding is redefining what’s possible in biotherapeutics.
Accelerating Biopharmaceutical Innovation
TrueBinding's contract development and manufacturing services offer unparalleled benefits for clients in the biopharmaceutical industry. By leveraging our advanced technology and expertise, our teams can accelerate the development process, ensuring rapid and efficient production of high-quality monoclonal antibodies, ultimately enabling clients to bring their innovative therapies to market faster and more cost-effectively.
TB006 Expanded Access Program
The FDA-approved Expanded Access Program (EAP) for TB006 allows eligible patients with Alzheimer’s disease to gain early access to this investigational therapy. Designed for individuals who have exhausted all other treatment options, the program provides a potential path forward when no approved alternatives remain. Through the EAP, TrueBinding is committed to addressing urgent unmet medical needs while continuing the clinical development of TB006.
Completion of Phase 1b/2a Clinical Trial for Alzheimer's Disease
Topline data from a one-month TB006 treatment regimen shows improvements in Clinical Dementia Rating-Sum of Boxes (CDR-SB) in patients, indicating the potential of slowing or reducing clinical decline. Key secondary endpoints were consistent with the primary findings that TB006 improved cognition and function in patients
Latest News
May 26, 2024
The FDA has renewed the Expanded Access Program (NCT05959239) for TB006 in treating dementia and Alzheimer's disease. This renewal allows existing patients to continue receiving TB006 outside of traditional clinical trials and offers hope for patients seeking alternative treatment options.
July 9, 2024
The FDA has approved TrueBinding to proceed clinical trials for TB006, a new therapeutic candidate for treating adult autism spectrum disorder (ASD). The clinical trials (NCT06500637) will assess TB006’s safety and efficacy, offering hope for new, effective treatment options for those with ASD and potentially improving their quality of life.
Nov 18, 2024
TrueBinding has cleared an FDA IND application for TB006 for potential disease modification of Parkinson’s Disease. A multi-center, placebo-controlled, Phase 2A trial (NCT06773962) of TB006 in the U.S. will be evaluating the safety and efficacy of this treatment in patients with early to mild Parkinson’s Disease.