TrueBinding, Inc. has announced that the FDA has cleared its Investigational New Drug (IND) application for TB006, a Biologic IgG4 antibody designed to neutralize Galectin-3, for the potential treatment of Parkinson’s Disease (PD). This clearance paves the way for a Phase 2a clinical trial to evaluate TB006 as a disease-modifying therapy.
Targeting Galectin-3 in Parkinson's Disease
TB006 is a humanized monoclonal antibody that targets Galectin-3, a protein implicated in the aggregation of alpha-synuclein and the activation of pro-inflammatory microglia. By neutralizing Galectin-3, TB006 aims to dissociate neurotoxic oligomers, reduce inflammation, and promote lysosomal repair. The therapy is administered via monthly intravenous infusions.
Phase 2a Trial Details
The upcoming Phase 2a trial is a multi-center, placebo-controlled study designed to evaluate the safety and efficacy of TB006 in patients with early to mild Parkinson’s Disease. The trial will enroll adults aged 50 to 80 years with confirmed Hoehn and Yahr grade 1 or 2 Parkinson’s Disease, diagnosed within the past five years. Participants must be either not on any Parkinson’s Disease medications or only on immediate-release Levodopa-containing therapy. The trial aims to enroll 62 patients, with an estimated primary completion date in Q1 2026.
Parkinson's Disease: A Growing Concern
Parkinson’s disease is a progressive neurodegenerative disorder affecting dopamine-producing cells. Nearly one million people in the U.S. and 10 million people worldwide are living with PD, with approximately 90,000 new cases diagnosed annually in the U.S. As the second most common neurodegenerative condition after Alzheimer’s, the prevalence of Parkinson’s is expected to rise significantly due to the aging population.
The disease is characterized by motor symptoms such as tremor, slow movement, stiffness, and balance issues, as well as non-motor symptoms including anxiety, sleep disturbances, and cognitive changes. While Carbidopa/levodopa remains a standard treatment, there is a significant need for therapies that can modify the course of the disease.
TrueBinding's Broader Pipeline
TrueBinding, Inc. is focused on developing innovative monoclonal antibodies for neurodegenerative diseases, including Alzheimer’s Disease and Parkinson’s Disease. TB006 has also shown promise in preclinical studies for Alzheimer’s Disease, demonstrating a reduction in Aβ/Tau protein aggregation and neuroinflammation, along with improved cognitive performance. A Phase 1b/2 proof-of-concept trial in Alzheimer’s patients showed a positive trend toward improvements in cognition and functioning, and TB006 has been granted conditional use through an Expanded Access Program.
