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An Investigational Drug that Shows Promise
TB006 by True Binding
TB006 is an experimental agent for Alzheimer’s disease. Because of the efficacy and relative safety of this agent it has been approved for compassionate use after Phase II-a trials. We at Brain Regain have the capability of administering this agent for appropriate candidates that meet eligibility criteria.
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TB006 Protocol
Expanded Access with TB006 Treatment in Adults with Alzheimer’s Disease and Related Dementias. Who can participate: For treating Alzheimer’s disease or other forms of dementia, the inclusion criteria include male or female patients > 55 years who were diagnosed with symptomatic AD or related dementia, meeting the clinical criteria for AD with an estimated or actual MMSE score of 24 or less. The patient must also be unable or ineligible to enroll in another clinical trial for their condition, or has tried and failed the other AD medicines.
Brief Title
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
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.
Brief Summary
Patients will receive TB006 at a dose of 4,000 mg intravenously over 1 hour every 28 days (± 5 days). The 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.
Number of Participants
This is an open access program, thus there is no limit on the number of patients that can participate.
Summary of Key Eligibility Criteria
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
About True Binding & TB006
About True Binding
About True Binding
About True Binding
TrueBinding, Inc. is a clinical stage biotherapeutics company focused on pioneering the development of innovative monoclonal antibodies for the treatment of some of the most challenging neurodegenerative diseases including Alzheimer’s Disease and Parkinson’s Disease. The Company is focused on rapidly advancing its lead drug candidate, TB006, a humanized monoclonal antibody targeting Galectin-3.
About TB006
About True Binding
About True Binding
TB006 is a humanized monoclonal antibody that, based on preclinical data and advancing clinical studies, has the potential to improve cognition and functioning of patients with Alzheimer’s Disease and Parkinson’s Disease. In pre-clinical evaluations, Galectin-3 was shown to intrinsically promote the aggregation of Aβ and pTau proteins. In Alzheimer’s Disease in vivo model studies, TB006, showed promising capabilities in significant reduction of the aggregation of Aβ/Tau proteins and neuroinflammation, and significant improvement of cognitive performance, which show potential therapeutic effect of TB006 in addressing underlying pathology and ameliorating the course of Alzheimer’s Disease. In a Phase 1b/2 proof-of-concept trial in mild to severe Alzheimer’s patients, TB006, demonstrated a positive trend toward improvements in cognition and functioning. TB006 has also been evaluated in a Phase 2 open-label extension trial in patients with Alzheimer’s Disease and has been allowed by the FDA for conditional use through an Expanded Access Program. Clinical trials demonstrated that TB006 was well tolerated with a favorable safety profile.
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