TB006 is an investigational drug developed by TrueBinding. In clinical trials, TB006 is currently being evaluated for its potential effects on memory and cognition. TrueBinding's Phase 2b trial is expected to begin in early 2027. TB006 is available to eligible patients at Universal Neurological Care through the Expanded Access Program (EAP), a program authorized by the FDA and carefully regulated to ensure patient safety and compliance with medical standards.
TB006 is experimental and still undergoing clinical testing. To learn more, please schedule a consultation with Dr. Asad.
TB006 is being evaluated for its potential to reduce plaque buildup and neuroinflammation.
The safety and tolerability of TB006 continue to be evaluated in ongoing studies.
TB006 is currently undergoing clinical trials and is not yet FDA approved. There are two ways to obtain TB006. One option is through participation in a clinical trial; however, not everyone meets the eligibility criteria, and there is possibility of getting enrolled into placebo group.
The alternative is through the Expanded Access Program (EAP). The FDA allows eligible patients to access investigational treatments when there is no satisfactory alternative treatment available. TB006 was authorized for compassionate use (EAP) for dementia in June 2023.
Interested patients or caregivers should contact us to schedule a screening consultation. For this service, our team will evaluate eligibility, perform a history or physical exam including EKG, SNP genetic test, etc. We will discuss the risks and benefits of participation, submit all the requisite orders for lab and imaging testing, and submit your application to the drug sponsor for approval.
If you enroll in and are accepted into a clinical trial, then the medication is free. However, there is a chance to be randomized into placebo group.
If you decide to obtain TB006 through the Expanded Access Program, you need to be aware that this medication is expensive. The price of the medication includes the manufacturing cost of the drug, the physician/clinic fees for administering and monitoring the treatments, and charges for exams, imaging, labs that are needed as part of the EAP program.
Please contact our office at (904) 404 7044 for pricing.
Since TB006 is still under investigation we can only administer the medication to those who meet certain eligibility criteria.
If you feel you meet the above criteria and are interested in learning more about TB006 please reach out to our office to discuss details about fees, testing, and structure of the EAP program.
For additional information about TB006 and the Expanded Access Program, visit TrueBinding’s website at www.truebinding.com or contact us directly using our contact information below.
Expanded Access with TB006 Investigational Treatment in Adults with Alzheimer’s Disease and Related Dementias
TB006 Expanded Access Compassionate Use Indication: Alzheimer’s disease (clinical diagnosis) Rationale: Administer TB006 to a patient with Alzheimer's disease (AD) or related dementias who has no other disease-modifying treatment options and are not able to participate in any ongoing clinical trials.
The aim of this protocol is to provide TB006 to patients with AD and related dementias, who have no treatment options and are unable or ineligible to participate in a clinical trial. Other than adverse events (AEs) and serious adverse events (SAEs), no data are collected.
Patients will receive TB006 at a dose of 4,000 mg intravenously over 1 hour every 28 days (± 5 days). The investigational treatment may continue as long as the investigator and patient believe the benefit outweighs the risk, until the Sponsor terminates the protocol or the development of TB006, or TB006 has been approved and marketed in the patient’s respective country.
Safety assessments recommended to be performed in this program include clinical chemistry, hematology and urinalysis analyses, vital signs, electrocardiograms (ECGs), brain magnetic resonance imaging (MRIs) without gadolinium for amyloid-related imaging abnormalities (ARIA) monitoring, Mini-Mental State Examination (MMSE) scores, physical examinations and assessments of AEs, and SAEs. These are to ensure patient safety. All assessments are recorded in the patient’s chart. The Sponsor will only collect AE and SAE data.
This is an open access program, thus there is no limit on the number of patients that can participate.
The following patients may qualify for participation: patients diagnosed with symptomatic AD who have cognitive disability, and whose other medical conditions are stable and well managed. Patients who are not able to receive alternative AD medications, either due to intolerance or contraindication(s), or have taken alternative medications and have not responded. Patients who are unable or ineligible to participate in an AD clinical trial.
Compound: TB006 TrueBinding, Inc. Protocol TB006 Expanded Access Compassionate Use
Protocol Date and Version: 30 May 2023; v 1
Summary of Statistical Considerations: Safety analyses will be performed on all patients who receive any dose of TB006.
AEs will be coded using the most recent version of Medical Dictionary for Regulatory Activities (MedDRA). The incidence of AEs will be summarized by system organ class (SOC) and preferred term (PT). Similarly, summaries will be produced for AEs by severity, SAEs, treatment related AEs, and AEs leading to discontinuation. AEs are collected from the first dose of TB006; thus, all AEs are considered treatment-emergent AEs.
No statistical analyses are planned.
Data Monitoring/Other Committee: No
