United Neuroscience has announced a positive top-line results from the Phase IIa clinical study of UB-311 vaccine in patients with Alzheimer's disease.
The clinical-stage biotech company found that the novel synthetic peptide vaccine targeting beta amyloid met the primary aims of safety and immunogenicity with a 96% response rate.
UB-311 is a novel UBITh active vaccine targeting the N-terminus of Aβ peptides, the most advanced Alzheimer's vaccine in all clinical development.
Currently, there is no active vaccination against beta amyloid, meaning these test results are fairly pivotal, as there were also no serious side effects reported.
The study was a double blinded, placebo-controlled study evaluated the safety and immunogenicity of prolonged dosing with two different dosing regimens of the Alzheimer’s vaccine
"The positive results show that we can safely raise and maintain anti-Aβ antibody titers in a predictable and sustained manner," said Peter Powchik, executive vice president of Research and Development at UNS.
"High response rates, reproducibility of response and generation of antibodies directed to relevant toxic protein species are key elements of an effective therapeutic vaccine for neurodegenerative conditions. The UNS platform is proving that it can deliver on these requirements.”
Additional results, including future analysis of secondary endpoints and other data, are expected to be presented at upcoming medical meetings, such as the 14th International Conference on Alzheimer's and Parkinson's Diseases, and published in peer reviewed medical journals.
The subjects from the completed study are expected to roll over into a long-term extension study, and will be offered continued treatment with UB-311.