FDA Approval

TB006 is authorized for use under the FDA-approved Expanded Access Program

TB006 is still working its way through the FDA approval pipeline, but it is authorized for the Expanded Access Program (EAP), also known as compassionate use.  

This means patients with severe or life-threatening illnesses can receive investigational medications outside of clinical trials, when there are no other comparable treatment options available.  

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.    

Key summary points from the clinical results:

1

Topline data from a one-month TB006 treatment regimen demonstrate improvements in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score (primary endpoint), suggesting the potential to slow cognitive decline or reverse disease progression. Results for key secondary endpoints were consistent with this primary endpoint, further indicating that TB006 improved cognition in patients.

2

TB006 treatment was well-tolerated, with only minor adverse events (AEs) reported.

3

In the Open Label Extension (OLE) study, 119 patients were treated for an average of 8 months. The primary cognitive and functional endpoint, CDR-SB, was well-maintained around baseline levels across the entire patient population.

Patient Results

Patient Results from TB006 Treatment

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91 year-old woman
Midwest, USA

Once unable to manage daily tasks, a 91-year-old woman now dresses herself, participates in activities, and saw her MMSE score (a tool used to assess mental status) jump from 15 to 25.

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90 year-old woman
Midwest, USA

Once plagued by nausea, high blood pressure, incontinence, and extreme fatigue, a 90-year-old woman with dementia is now active with family, has stable blood pressure, tolerates cold, and feels better overall. Her MMSE score rose from 18 to 25.

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