3 months of TB006 eased, reversed signs of Alzheimer’s disease: Trial

Nearly half of patients treated showed signs of cognitive gains, disease reversal

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by Steve Bryson, PhD |

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Nearly half of Alzheimer’s disease patients treated with TrueBinding’s investigational therapy TB006 for at least three months showed signs of disease reversal or cognitive improvement, according to data from an open-label extension (OLE) study.

The findings expand on data from a completed Phase 2a trial (NCT05074498) that preceded the OLE (NCT05476783) that showed a month of TB006 improved clinical signs, but failed to reach statistical significance compared with a placebo.

“The three month or longer treatment in the OLE led to disease reversal or stabilization in the majority of participants with mild, moderate to severe [Alzheimer’s disease], which brings much needed new hope to those suffering from this devastating disorder,” Dongxu Sun, PhD, TrueBinding’s CEO, said in an emailed statement to Alzheimer’s News Today. “Additionally, that data is valuable for the design of new clinical trials of TB006.”

The company will discuss data from the Phase 2a trial and the ongoing OLE in a meeting with the U.S. Food and Drug Administration, with the goal of accelerating TB006’s development.

Major hallmarks of Alzheimer’s disease, the leading cause of dementia, include the formation of toxic aggregates (clumps) of certain proteins in the brain, called amyloid plaques and tau tangles.

Galectin-3 (Gal-3) is a protein found at abnormally high levels in patients’ brains. It’s known to stimulate toxic protein aggregates to form and signal the release of pro-inflammatory signaling molecules, further contributing to brain damage.

TB006 is an antibody-based therapy designed to block Gal-3, preventing the protein aggregates from forming and inflammation. The goal is to improve cognition and functioning at all stages of the disease.

According to TrueBinding, preclinical studies indicated TB006 can significantly reduce aggregation and inflammation and improve cognitive performance.

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Results of Phase 1b/2 clinical trial

A Phase 1b/2 proof-of-concept trial was launched to evaluate TB006’s safety and short-term effectiveness in 157 patients, ages 50 and older, with mild to severe disease.

The Phase 1b portion was a one-month ascending dose phase to assess its safety, tolerability, and pharmacological properties. In the Phase 2 efficacy portion, participants were randomly assigned either TB006 or a placebo weekly for a month. They were followed for up to 104 days (about 3.5 months).

Top-line data, reported in a previous company press release, showed a five-dose weekly regimen of TB006 had the potential to slow or reduce clinical decline, as assessed by the Clinical Dementia Rating-Sum of Boxes (CDR-SB). Clinical improvements failed to reach statistical significance compared with a placebo, however.

TB006 did led to significant improvements in the Mini-Mental State Examination (MMSE) by day 36, a key secondary outcome assessing cognitive function. It also significantly reduced blood levels of amyloid-beta-42, a toxic form of the amyloid-beta protein that clumps in patients’ brains.

The therapy was also found to be safe and well tolerated over the follow-up, with infusion-related reactions being the most common side effect. No safety signals were detected in standard lab and clinical tests and no serious treatment-related side effects were reported.

“The one-month treatment of Alzheimer’s disease with TB006 in the blinded Phase 2a trial yielded strong clinical data pointing to a trend of disease reversal in moderate to severe cases, but Alzheimer’s disease is a chronic disease, so some people may require longer treatment to show improvement,” Sun said in a separate press release.

OLE study data shows continued positive signs

In the long-term OLE, participants are being treated with TB006 once a month and will be followed for up to two years.

Among the 79 participants who completed a three-month OLE regimen, 47% showed signs of disease reversal or cognitive improvement and 28% showed the disease was stabilizing, according to TrueBinding.

“A significant number of participants in the OLE study, including those with severe Alzheimer’s Disease, have shown disease reversal or stabilization after only three months of treatment, and without significant adverse events,” Sun said.

The company plans to launch a Phase 2b study to collect more data over a full year and reveal “more about the potential for use of TB006 in treating Alzheimer’s disease,” Sun said.