TB006 is an investigational drug developed by TrueBinding (www.truebinding.com). In their Phase 2a clinical trial, patients who received TB006 for one month demonstrated signs of symptom reversal and improvements in memory and cognition, as evidenced by changes in their CDR-SB (Clinical Dementia Rating – Sum of Boxes) scores. While TrueBinding is planning a Phase 2b trial in 2025, the drug is available to patients through compassionate use or early access. We are pleased to offer this investigational treatment to patients at Universal Neurological Care through the Expanded Access Program (EAP). The EAP is a program approved by the FDA and is carefully regulated to ensure patient safety and compliance with medical standards.
Please be aware that, as TB006 is still in the investigational stage, the benefits of the drug cannot be guaranteed for everyone. There is a possibility of benefit, but individual results may vary. However, if you or your loved ones are suffering from dementia and have exhausted other treatment options, TB006 may offer promising new hope. To learn more, please schedule a consultation with Dr. Asad.
TB006 works by binding to and lowering amounts of Galectin-3, a different mechanism than any of the currently approved Alzheimer’s medications. Galectin-3 binds to amyloid beta and acts like glue causing amyloid beta proteins to stick to one another and form larger plaques. These plaques then deposit in the tissue between neurons blocking signals and leading to cognitive impairment. In addition, Galectin-3 is proinflammatory and activates the brain’s immune system (microglial cells) leading to neural inflammation and nerve cell damage/destruction. Galectin-3 is generally very high in the brains of patients with Alzheimer’s disease. TB006 prevents Galectin-3 from attaching to amyloid beta (blocking amyloid plaque formation) and prevents it from causing microglial activation. In doing so, TB006 may potentially decrease the amount of beta amyloid plaques and lower inflammation allowing nerve cells to heal and function more optimally.
Following prerequisite studies in laboratory animals and pharmacokinetic studies in human patients, TB006 was initially evaluated for efficacy in a Phase 1b/2a Randomized Controlled Trial (RCT), with preliminary data presented in 2022. The results demonstrated a 63% improvement in CDR-SB (Clinical Dementia Rating – Sum of Boxes) scores within one month of treatment when comparing the TB006-treated group to the placebo group. In the Open-Label Extension (OLE) trial, nearly half of the patients treated with TB006 for three months or longer exhibited signs of disease reversal or cognitive improvement, as evidenced by changes in their CDR-SB scores.
TB006 has been well tolerated in clinical trials, with the most common side effects being mild infusion-site reactions, headaches, upset stomach, and back pain. The currently approved anti-plaque AD treatments all carry a black box warning due to the high incidence of ARIA (amyloid-related imaging abnormalities) reported in their clinical trials. However, to date, only one asymptomatic ARIA has been reported in the TB006 trial. TB006 was safe and well tolerated throughout the 3.5-month observation period in Phase 2a, as well as in the OLE study, where patients received an average of 8 months of treatment. No safety signals were detected in clinical laboratory evaluations, imaging, or ECGs.
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 approved for compassionate use (EAP) for dementia since 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
