Expanded Access Program (EAP) for TB006
TB006 Brings Multifaceted Hope for Dementia and Beyond
What is the Expanded Access Program (EAP)?
Expanded access, also known as compassionate use, is a program that allows patients with severe or life-threatening illnesses to receive investigational medications outside of clinical trials. It provides access to these medications, which have not yet been approved by the FDA, when there are no other approved treatment options available. Patients eligible for this program may have already tried and failed approved medications, or they may be unable to take currently available medications due to side effects or contraindications. Additionally, expanded access programs cater to situations where no clinical trials are available or the patient does not meet the eligibility criteria for such trials. By granting access to investigational medications, these programs offer a compassionate approach to provide potential benefits to patients who have exhausted all other alternatives for their conditions.
Based on clinical trial results, TB006 has demonstrated itself to be a well-tolerated medicine, offering a restorative and anti-inflammatory effect in treating dementias, including Alzheimer’s. This revolutionary drug targets Galectin-3 (Gal3), a pleiotropic protein with numerous biological functions, including:
Formation of harmful brain aggregates: Gal3 contributes to the formation of toxic oligomers and plaques, disrupting neuronal communication and leading to cognitive decline.
Regulation of inflammation: Overexpression of Gal3 triggers excessive microglial activity and chronic neuroinflammation, further damaging neurons.
By selectively blocking Gal3, TrueBinding hypothesizes that TB006 can disrupt both of these pathways—preventing harmful brain aggregates while reducing neuroinflammation—potentially improving cognitive function.
Patients participating in the Expanded Access Program include those with:
Vascular dementia
Frontotemporal dementia
Lewy body dementia
Dementia with mixed pathology
TB006 offers immense hope for millions of individuals and their families. TrueBinding’s mission is to combat dementia, paving the way for a brighter future and an improved quality of life for those affected by this debilitating condition.
Are there any ongoing clinical trials for TB006?
TrueBinding has completed the Phase 1b/2a trial and recruitment for the Open Label Extension (OLE) trial for TB006 in the fight against Alzheimer’s disease. The Phase 1b/2a trial demonstrated significant improvements in cognition and function in patients with mild dementia after one month of treatment. It also showed improvements in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) for most patients, suggesting a potential slowing or reduction of clinical decline. In the OLE trial, nearly half of the patients treated with TB006 for three months or longer exhibited some level of cognitive improvement. [Click here to read the clinical data summary.]
Until the next trial for AD patients is initiated, there are no actively recruiting trials for TB006. Therefore, we have chosen to offer the Expanded Access Program (EAP) to provide patients with continued access to this drug.
How can I participate?
If you are a patient or caregiver:
Contact us with enrollment questions by filling out the form on the right.
If you have non-enrollment related questions, please fill our the inquiry on the bottom of this page.
If you are a Physician:
Contact us using the form on the right to learn more about the program and to receive the Investigator’s Brochure and NDA.
*Personal data will be used only for business purposes. It will not be shared or sold to third parties.
Is this a paid program?
Currently, there is a cost associated with participating in the TB006 expanded access protocol. The manufacturing of TB006 is an expensive process, and the intention is to recover the costs incurred in producing the drug. The specific cost will be communicated to you by your physician. It's important to note that the charges aimed at covering manufacturing costs have been approved by the FDA.
In addition to the cost of the medication, you will also be responsible for covering the expenses related to your physician's fees for treating you and the costs associated with laboratory tests and other assessments required to monitor the progress of your treatment. These costs are separate from the manufacturing costs of TB006 and will be your responsibility as the patient participating in the expanded access program.
Frequently Asked Questions
If you have any further questions about the Extended Access Program, please email us at EAP@truebinding.com
Inquiry Request
If you are a TB006 EAP patient or caregiver and have any medical-related concerns or questions, please contact your TB006 provider.
For other questions, please complete the Health Insurance Portability and Accountability Act (HIPAA) release form provided below. By completing the form, you authorize the disclosure of your health information. After completion, you will be directed to a second page, where you can fill out the inquiry form and upload documents.