Vaxxinity Announces Publication of UB-311 Safety, Tolerability, Immunogenicity, and Clinical Efficacy Data from Phase 2a Trial in Alzheimer’s Disease - Seite 2

“This publication supports the innovative work that we and our collaborators are conducting to advance UB-311 for the potential treatment, and even prevention, of Alzheimer’s disease,” said Mei Mei Hu, CEO of Vaxxinity. “Imagine expanding the addressable patient population of beta-amyloid immunotherapies by multiple orders of magnitude, potentially over 1,000x, and delivering life-changing medicine at a fraction of the cost. That is our vision for UB-311 and the potential power of active immunotherapies.”

Jeffrey Cummings, M.D., Ph.D., Director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada, Las Vegas, and co-author of the paper, commented, “The UB-311 Phase 2a program accomplished its goals of establishing safety and tolerability, while generating high levels of anti-amyloid antibodies. The gradual, natural titration of antibody titers through this approach may have contributed to a lack of ARIA-E in this study. Vaccine approaches such as UB-311 represent important ways forward in advancing treatment and prevention of Alzheimer’s disease and offer the potential to transform the treatment landscape by providing participants with an accessible therapeutic option.”

Although the trial was not powered to make conclusions about efficacy, secondary efficacy outcomes on cognitive, functional, behavioral, and global assessments such as ADAS-Cog, MMSE, ADCS-ADL and CDR-SB were evaluated. Trends of slowing disease progression were observed across key cognitive and functional measures for UB-311-treated versus placebo-treated participants over 78 weeks of observation, including a 48% slowing of decline on CDR-SB in the UB-311 quarterly boosting group.

The publication titled, “Safety, tolerability, immunogenicity, and efficacy of UB-311 in participants with mild Alzheimer's disease: a randomised, double-blind, placebo-controlled, phase 2a study,” is available online here.

About Alzheimer’s Disease

Alzheimer’s disease (AD), the most common form of dementia, is a progressive neurodegenerative disorder that slowly destroys memory and cognitive skills and eventually the ability to carry out simple tasks. Its symptoms include cognitive dysfunction, memory abnormalities, progressive impairment in activities of daily living and a host of other behavioral and neuropsychiatric symptoms. The exact cause of AD is unknown, but genetic and environmental factors are established contributors. Accumulation of the beta-amyloid peptide is a key component of AD pathophysiology, with current evidence supporting the hypothesis that beta-amyloid deposits in the brain contribute to disease progression. The FDA has approved two immunotherapies that target beta-amyloid pathology in the brain. AD affects more than six million people in the United States and 44 million worldwide. The economic burden of AD is expected to surpass $2.8 trillion by 2030.