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.
By selectively blocking Gal3, TB006 disrupts the pathways that cause these diseases. 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 dementias, paving the way for a brighter future and improved quality of life for those affected by this debilitating condition.
Expanded access, also know 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 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.
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.
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.
