UB-311 Vaccine Safe in Mild Alzheimer’s Patients, Phase 2a Trial Shows

UB-311 Vaccine Safe in Mild Alzheimer’s Patients, Phase 2a Trial Shows
United Neuroscience’s vaccine candidate UB-311 was safe and well-tolerated in patients with mild Alzheimer's disease, according to results from a Phase 2a clinical trial. Patients who participated in this trial are now eligible to enroll in a long-term follow-up study that will continue to assess the vaccine’s safety for 108 weeks. Trial results, “Active Immunotherapy with UB-311 vaccine: Results from a Phase IIa, randomized, double-blind, placebo-controlled, 3-arm parallel-group, multicenter study” were recently presented during the 14th International Conference on Alzheimer's and Parkinson's Diseases and related neurological disorders in Lisbon, Portugal. UB-311, developed by United Neuroscience, a spin-off of United Biomedical, is a synthetic peptide vaccine that triggers an antibody response against beta-amyloid — whose accumulation in the brain is a hallmark of Alzheimer’s disease — clearing it away without causing potentially harmful inflammation. Results from a Phase 1 trial (NCT00965588) showed that UB-311 was safe and well-tolerated, and able to trigger high levels of anti-beta-amyloid antibodies in patients with mild to moderate Alzheimer’s disease. The data suggested that the treatment led to a stabilization of patients’ cognitive abilities. The Phase 2a trial (NCT02551809), conducted at multiple sites in Taiwan, enrolled 43 patients, ages 60 to 90 years, with mild Alzheimer’s dementia. Most participants (81.4%) were APOE-E4 carriers, a genetic factor associated with a higher risk of developing early Alzheimer’s disease. Patients were randomized to receive intramuscular injections of UB-311 at different doses or a placebo (control). Among those who received the vaccine, one group received a total of seven doses of
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