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.
TB006 is a groundbreaking, well-tolerated medicine offering a restorative and potentially anti-inflammatory approach to treating Alzheimer's disease (AD) and a wide range of dementias. This revolutionary drug targets Galectin-3 (Gal3), a protein with dual roles in the progression of these diseases:
Formation of harmful brain aggregates: Gal3 contributes to forming toxic oligomers and plaques, disrupting communication between neurons and leading to cognitive decline.
Regulation of inflammation: Gal3 overactivation triggers excessive microglial activity and chronic neuroinflammation, further damaging neurons.
By selectively blocking Gal3, TB006 disrupts both of these pathways. It prevents harmful brain aggregates while reducing neuroinflammation, potentially reversing some damage and restoring cognitive function. Early clinical trials show promising results for treating various dementias, including:
Vascular dementia
Frontotemporal dementia
Lewy body dementia
Dementia with mixed pathology
Beyond these specific types, TB006's unique mechanism of action suggests its potential to benefit individuals with other dementias as well. This opens up exciting possibilities for the future of dementia treatment.
TB006 offers immense hope for millions of individuals and their families. It represents a significant breakthrough in the fight against dementia, paving the way for a brighter future and 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/2 trial and has completed recruitment for the Open Label Extension (OLE) trial for TB006 combating Alzheimer’s disease. The Phase 1b/2 trial demonstrated significant improvements in cognition and function in many patient after just one month of treatment. Patients showed improvements in the Clinical Dementia Rating-Sum of Boxes (CDR-SB), indicating a potential slowing or reduction of clinical decline. Secondary endpoints further supported these findings, and amyloid beta (Aβ) 42 plasma levels were reduced. In the OLE trial nearly half of the patients treated with TB006 for three months or longer showed signs of disease reversal or cognitive improvement. Review topline data by clicking here.
Until the next trial has been initiated, there are no actively recruiting trials for TB006. Therefore we have opted to offer the Expanded Access Program (EAP) to provide patients continued access to the breakthrough 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.
Contact your treating physician to voice interest in the EAP program for TB006.
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.