How UB-311 works
A peptide is a short stretch of amino acids, which are the building blocks of proteins. UB-311 is composed of amino acids 1-14 in the beta amyloid protein. Toxic beta amyloid clumping in the brain is a hallmark of Alzheimer’s. The clumping leads to the nerve cell damage seen in the disease, scientists say.
The vaccine is designed to provoke an antibody response against beta amyloid, clearing it away, without triggering potentially damaging inflammation. United Biomedical used its UBITh technology to identify the peptide for the vaccine. The company packaged it in a proprietary vaccine-delivery system.
UB-311 in clinical trials
Preclinical-trial studies in small mammals, baboons, and macaques showed that the vaccine generated antibodies against beta amyloid. The antibodies were able to stop the toxicity that beta amyloid was generating, and help clear the clumps.
United Neuroscience has also been testing intramuscular injections of UB-311 in a number of human trials in Taiwan.
One was a Phase 1 clinical trial (NCT00965588) of 19 patients with mild to moderate Alzheimer’s disease. The trial assessed its ability to trigger an immune response, safety and whether patients could tolerate it well. The vaccine met all three goals, results showed. The most common adverse events were injection site swelling in four patients and agitation in four patients.
Researchers also conducted an observational trial (NCT01189084) on the vaccine’s long-term effectiveness. The study, which involved 14 patients, was completed in 2011, but no results were disclosed.
United Neuroscience has completed a Phase 2a trial (NCT02551809) evaluating UB-311’s safety and tolerability and also its ability to trigger an antibody response. The study also assessed the vaccine’s effect on patients’ cognitive, neuropsychiatric, and other functioning, including learning and memory. The study enrolled 43 patients with mild-to-moderate Alzheimer’s disease who were given either one of two treatment dosing regiments or placebo and followed for 78 weeks.
The company released results in January 2019 that UB-311 was safe and well-tolerated in patients. They also reported a 96% response rate of patients’ immune systems to the treatment, indicating that the antibody was working to generate an immune response. Results also indicated a positive trend in treatment for the secondary outcomes of the trial including cognitive and functional tests, however, the number of participants was not large enough to reach significance levels.
Results from the study were also presented at the 14th International Conference on Alzheimer’s and Parkinson’s Diseases in March of 2019.
An extension study (NCT03531710) for patients who were enrolled in the Phase 2a trial has also been started. Participants will receive another 3 or 5 doses of UB-311 over a 96 week treatment period followed by a 12 week follow-up period to evaluate the long-term effects of treatment. Primary outcomes of the study are safety and tolerability as well as the immune response to UB-311 with secondary outcomes being changes in cognition, functionality, and biomarkers for Alzheimer’s. The results of this study are expected in March 2021.
Page updated: Aug. 27, 2019
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