TB006
Expanded Access Program

This investigational drug targets Galectin-3 (Gal3), a protein with dual roles in the progression of these diseases:

1. Formation of harmful brain aggregates: Gal3 contributes to forming toxic oligomers and plaques, disrupting communication between neurons and leading to cognitive decline.

2. Regulation of inflammation: Gal3 over-activation triggers excessive microglial activity and chronic neuroinflammation, further damaging neurons.

 

By selectively blocking Gal3, TB006 potentially disrupts both of these pathways. It potentially 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 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 hope for millions of individuals and their families. It represents a potentially significant breakthrough in the fight against dementia, paving the way for a brighter future and improved quality of life for those affected by this debilitating condition.

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Dr. Joshua Pal MD is the principal investigator for the administration of this medication at San Diego Center for Restorative Medicine.

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Patient Inclusion Criteria

• Greater than 55 years of age

• Actual or estimated MMSE test score between 6 to 24

  • Conducted in-person, within last 3 months

• Has a serious or immediately life-threatening condition

• Failed at least one dementia medication (e.g. Aricept, Exelon, Namenda…)

  • This criterion is waived if no available first-line treatment (Frontotemporal dementia, vascular dementia, etc.)

• Unable or ineligible to enroll in another clinical trial for their dementia

• Clear documentation of (1) the patient’s dementia, (2) treatments attempted so far, (3) response to those treatments

• The investigator and the parent/caregiver must be informed of the potential risks and obligations of the program and decide whether the potential benefit outweighs the risk of receiving an investigational drug therapy based on the patient’s medical history and program eligibility criteria

• Saliva test results with heterozygous or wild-type LGALS3 (rs4644 SNP)

  • Test is available from EndoDNA or IntellxxDNA

  • https://shop.endodna.com/collections/physical-virtual-kits/products/gal-3-function-activity-dna-test-single-text

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Patient Exclusion Criteria

• Any significant uncontrolled medical condition

• Active infection and/or immunosuppressive medical condition

• Available alternative therapy

• Major surgery or trauma in the last 14 days

• Participated in a clinical trial with an investigational drug within the past 6 months

• Enrolled in a previous TB006 clinical trial and either did not complete the clinical trial or had a significant treatment-related adverse event that could cause an undue risk

• On non-FDA approved treatments

• On treatments that may impact TB006 (e.g. Humira)

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Treatment Time:

Up to 60 minutes

TB006 treatment is a monthly IV infusion, which takes at least 1 hour. Each dose contains 4000mg of the drug. Treatment may continue indefinitely and may be discontinued at any time.

 

Frequency:

Monthly (3-month minimum)

 

$4,500 per IV treatment

 

What are the side effects of using TB006?

Up to date, from our phase 1b/2a report, there were no severe adverse events. TB006 was well tolerated and the most common adverse event was infusion reaction. The side effects that have been reported, were mostly mild and lasted only a short time. The most common side effects so far are: • Headache • Upset stomach • Back pain

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Who Sponsors This Study?

Lead: TrueBinding, Inc.
Source: ClinicalTrials.gov ID: NCT05074498

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TB006 is produced and made available by True Binding  https://www.truebinding.com/expanded-access