FDA-Authorized Expanded Access Program (EAP) For Treating Alzheimer’s and Related Dementias
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.
TrueBinding evaluates expanded access requests for TB006 in accordance with FDA regulations (21 CFR 312 Subpart I). Requests are reviewed based on the following criteria:
• The patient has a serious or life-threatening condition
• No comparable or satisfactory alternative therapies are available
• The potential benefit justifies the potential risks
• Providing access will not interfere with ongoing clinical development
• The treating physician agrees to oversee treatment
All requests must be submitted by a licensed treating physician. Please click here to download the approved provider list.
Based on clinical trial preliminary results and current EAP data, TB006 was generally well-tolerated. Data suggest that TB006 may target neuroinflammatory pathways and factors associated with dementias, including Alzheimer’s. TB006 is an investigational monoclonal antibody that targets Galectin-3 (Gal3), a pleiotropic protein with numerous biological functions.
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
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.
What are the clinical results?
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.]
Important Safety and Investigational Status Information:
TB006 is an investigational drug. Its safety and effectiveness have not been established by adequate and well-controlled clinical trials. TB006 is available only under an FDA-authorized Expanded Access Program. Participation involves potential risks, unknown benefits, and costs. Patients must discuss these with their healthcare provider before enrolling
Are there any ongoing clinical trials for TB006?
TrueBinding has completed the Phase 1b/2a trial and the recruitment phase for the Open-Label Extension (OLE) study of TB006 in the treatment of Alzheimer’s disease.
While clinical trials for Parkinson’s disease and Autism spectrum disorder are currently ongoing, there are no active or recruiting trials for Alzheimer’s disease at this time. Until the next Alzheimer’s trial is initiated, we have launched the Expanded Access Program (EAP) to ensure that eligible patients can continue to access TB006.
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