TrueBinding has reported topline data from its Phase Ib/II clinical trial of TB006 to treat mild to severe Alzheimer’s disease (AD), with baseline Mini Mental State Examination (MMSE) scores of 2-24. 

The proof-of-concept, placebo-controlled, double-blinded, multicentre trial was carried out at 15 US sites in 157 such patients.

It is designed to evaluate the safety and short-term efficacy of TB006 in trial subjects.

Clinical Dementia Rating-Sum of Boxes (CDR-SB), an international cognitive and functional scale, was the primary endpoint of the trial.

According to the findings, one month of treatment with TB006 showed improvements. 

In the intent-to-treat (ITT) population, a treatment difference of 63% compared to a placebo was reported, indicating a -0.44-point score variation. 

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This data signifies a trend toward improvements in clinical function in trial subjects.

Key secondary endpoints also demonstrated cognition and functional improvements that attained or trended toward statistically significant data.

Such cognition improvements were seen along with a decline in amyloid beta (Aβ) 42 plasma levels.

Throughout the observation duration of 3.5 months, TB006 was found to be safe and well tolerated.

Infusion reaction was reported to be the most frequent adverse event, without any safety signals observed. 

An investigational humanised monoclonal antibody, TB006 showed the potential to boost the cognition and functioning of AD patients in preclinical and initial clinical studies.

TrueBinding CEO Dongxu Sun said: “These are exciting data from our proof-of-concept trial in patients with Alzheimer’s disease, demonstrating that our novel monoclonal antibody, TB006, showed improvements in cognition and function after just one month of treatment. 

“TB006 inhibits Galactin-3, which has a role in the formation of toxic protein oligomers that compromise normal neuronal function in the brain and lead to disease progression. 

“We look forward to studying TB006 for a longer duration to investigate its potential to further improve cognition and functioning and perhaps reverse the course of AD.”