FOSTER CITY, Calif., Nov. 18, 2024 (GLOBE NEWSWIRE) -- TrueBinding, Inc., a clinical-stage biotherapeutics company focused on pioneering the development of innovative monoclonal antibodies for the treatment of some of the most challenging neurodegenerative diseases and other serious diseases, has cleared an FDA Investigational New Drug (IND) application for the Biologic IgG4 antibody neutralizing Galectin-3, TB006, for potential disease modification of Parkinson’s Disease.
“FDA IND approval for TB006 is a major achievement for TrueBinding and a significant potential advancement for the treatment of Parkinson’s Disease worldwide,” said Alan K. Jacobs, M.D., FAAN, Chief Medical Officer of TrueBinding. “This first-in-class therapy harnesses the power of antibody selectivity to target the protein, Galectin-3, offering a promising new option for patients with no available disease-modifying treatment options.”
TB006 is a therapy that is delivered via monthly intravenous infusion and is designed to target and neutralize Galectin-3, possibly enabling the dissociation of neurotoxic oligomers including alpha-synuclein, reducing the activation of pro-inflammatory microglia and the release of associated cytokines, and providing reparative impact upon intracellular lysosomes. The approval of the IND application for the therapy will initiate the launch of Parkinson’s clinical trials in the U.S.
A multi-center, placebo-controlled, Phase 2A trial (NCT) of TB006 in the U.S. will be evaluating the safety and efficacy of this treatment in patients with early to mild Parkinson’s Disease. The trial will enroll adults aged 50 to 80 years of age who have confirmed Hoehn and Yahr grade 1 or 2 Parkinson’s Disease, less than five (5) years since diagnosis, and currently on no other Parkinson’s Disease medications or only immediate-release Levodopa-containing therapy. The estimated enrollment for the trial is 62 patients, and the estimated primary completion date is Q1 2026.
About Parkinson’s Disease1
Parkinson’s disease (PD) is a chronic and progressive neurodegenerative disorder that affects dopamine-producing cells.
- About 70% of people with PD experience tremor.
- PD symptoms often vary throughout the day, worsening with anxiety, fatigue or as medication wears off in between doses.
- Regular exercise can help manage PD symptoms and improve quality of life.
- Carbidopa/levodopa (brand name Sinemet) is still the “gold standard” in PD medications.
- It is common for people with PD to need adjustments to treatment as symptoms progress.
Parkinson’s disease is a disorder that causes a gradual loss of cells that produce dopamine, a chemical necessary for cell-to-cell neurotransmission. As dopamine decreases over time, movement and non-motor functionality become more difficult for people with PD. Dopamine also affects mood and motivation. In addition to dopamine, Parkinson’s changes several other brain chemicals.
Nearly one million people in the U.S. and 10 million people worldwide are living with PD. About 90,000 Americans are diagnosed with Parkinson’s each year. It is the second most common neurodegenerative condition after Alzheimer’s. The number of people with PD will increase substantially in the next 20 years due to our aging population.
The most visible and well-known signs of PD are movement (or motor) symptoms) such as tremor, slow movement, stiffness and balance issues. However, most people also develop non-movement (or non-motor) symptoms that impact mood and quality of life. These can include anxiety, sleep issues and thinking changes. Initial symptoms can be mild and sometimes mistaken for signs of aging.
Parkinson’s is a complex disease that affects everyone differently. For most people with PD, symptoms develop gradually over many years and worsen over time. Parkinson’s is typically diagnosed after 60, but people under 50 can also have PD. This is known as young-onset Parkinson’s disease (YOPD). About 4% of people with Parkinson’s have YOPD. Men are 1.5 times more likely to have Parkinson’s than women, and certain geographic areas and ethnic groups experience higher rates of PD.
Researchers believe that Parkinson’s is caused by a combination of genetic, environmental and other factors. About 10 to 15% of people with PD have a genetic link. There is no single test for Parkinson’s. A doctor makes a diagnosis based on a person’s symptoms, medical history and a physical examination. Sometimes conditions that look like PD can be ruled out by additional lab tests and imaging. To consider a diagnosis of Parkinson’s disease, a person must have bradykinesia (slow movement) in addition to one or more of the following:
- Shaking or tremor in a limb that occurs while it is at rest
- Stiffness or rigidity of the arms, legs, or trunk
- Trouble with balance and falls
A PD diagnosis can take time. When symptoms first appear, many people choose to speak to their family doctor, who may provide a referral to a neurologist if Parkinson’s is suspected. Some neurologists, called movement disorder specialists, have additional training in diagnosing and treating PD and other movement disorders. Though Parkinson’s varies from person to person, most people with PD need to take medications that boost, mimic or replace dopamine to manage their symptoms. Studies show that regular exercise also can benefit movement and non-movement symptoms and can improve overall quality of life. For some people, surgical intervention may be an option. People with PD can experience a wide range of complex symptoms, so building a team of healthcare professionals is key. This team may include physical, occupational and speech therapists as well as other specialists, including mental health professionals, a urologist or gastrointestinal doctor.
About TB006
TB006 is a humanized monoclonal antibody that, based on preclinical data and advancing clinical studies, has the potential to improve cognition and functioning of patients with Alzheimer’s Disease and Parkinson’s Disease. In pre-clinical evaluations, Galectin-3 was shown to intrinsically promote the aggregation of Aβ and pTau proteins. In Alzheimer’s Disease in vivo model studies, TB006, showed promising capabilities in significant reduction of the aggregation of Aβ/Tau proteins and neuroinflammation, and significant improvement of cognitive performance, which show potential therapeutic effect of TB006 in addressing underlying pathology and ameliorating the course of Alzheimer’s Disease. In a Phase 1b/2 proof-of-concept trial in mild to severe Alzheimer’s patients, TB006, demonstrated a positive trend toward improvements in cognition and functioning. TB006 has also been evaluated in a Phase 2 open-label extension trial in patients with Alzheimer’s Disease and has been allowed by the FDA for conditional use through an Expanded Access Program. Clinical trials demonstrated that TB006 was well tolerated with a favorable safety profile.
About TrueBinding, Inc.
TrueBinding, Inc. is a clinical stage biotherapeutics company focused on pioneering the development of innovative monoclonal antibodies for the treatment of some of the most challenging neurodegenerative diseases including Alzheimer’s Disease and Parkinson’s Disease. The Company is focused on rapidly advancing its lead drug candidate, TB006, a humanized monoclonal antibody targeting Galectin-3. For more information, visit www.truebinding.com.
Contacts:
Martin E. Schmieg
Chief Executive Officer
Email: mschmieg@truebinding.com
Tel. +1 (215) 300-9400
1 Reference is made to the Parkinson’s Foundation website, www.parkinsons.org
