• Results demonstrate specific targeting of beta amyloid oligomers and fibrils
  • Elicited antibody levels did not decrease with advanced patient age
  • Amyloid PET imaging and genetic testing in the ongoing phase 2 study efficiently identified patients at the early stages of disease
  • Absence of brain edema (ARIA-E) or other adverse events support continued development

DUBLIN, Ireland I November 1, 2017 I United Neuroscience (UNS), a clinical stage biotechnology company dedicated to developing best-in-class therapies for Alzheimer’s disease (AD), neurodegenerative disorders and orphan indications in neurology, today announced analyses of data for UB-311, its novel synthetic peptide vaccine targeting beta amyloid (Aβ) in the treatment of AD. The data showed that UB-311 was able to generate antibodies to specific Aβ oligomers and fibrils with no decrease in antibody levels in patients of advanced age. In addition, amyloid PET imaging and genetic screening for APOE4 status in the ongoing Phase 2 study demonstrated an efficient method to identify subjects with mild AD for disease modification trials in early-to-mild AD.

“Our goal is to develop a new class of immunotherapeutics for the treatment of neurological disease,” commented Mei Mei Hu, chief executive officer of UNS. “These data from trials of UB-311, an active vaccine we believe to be the most advanced in clinical development for Alzheimer’s disease, support the ongoing development of UB-311 as a targeted therapeutic autoantibody, or ‘endobody,’ approach. We look forward to results from the Phase 2 trial in the second half of 2018.”

“These analyses build on previously announced Phase 1 safety data and provide evidence in support of potential activity for UB-311 across age groups as an immunotherapy that can specifically target toxic oligomers and fibrils of amyloid,” said Ajay Verma, M.D., Ph.D., chief medical officer of UNS. “In addition, the baseline PET imaging results from our ongoing Phase 2 trial show the level of amyloid burden that we would hope to see in a trial targeting patients in the early stages of disease. Both imaging data and cognition assessments provide comfort in the safety profile of UB-311.” 

The analyses, presented today in late breaking poster presentations at the 10th Clinical Trials on Alzheimer’s Disease (CTAD) meeting included results from the completed Phase 1 study as well as data from 43 patients in the ongoing Phase 2 study of UB-311 for AD. A review of cases by the study safety group identified no signs of an adverse CNS event, including no evidence of brain edema (amyloid-related imaging abnormalities, ARIA-E) as assessed by MRI, in blinded data in Phase 2. The UNS ongoing Phase 2 active immunotherapy trial of UB-311 in patients with early-to-mild AD is fully enrolled.

About UB-311 in Alzheimer’s Disease

Active vaccination of human individuals against Aβ has yet to be safely and effectively achieved. Other active vaccine efforts have either reported low antibody titers and responder rates or significant safety issues such as T-cell mediated encephalitis. UB-311 is a novel UBITh™ active vaccine targeting the N-terminus of Aβ, designed to induce high B-cell specific responses while avoiding T-cell inflammation. UB-311 was shown to generate site-specific antibodies across mice, guinea pigs, macaques and baboons and to reduce Aβ1–42 oligomers, protofibrils, and plaque load in a transgenic mouse model of AD.

About United Neuroscience

United Neuroscience (UNS) is a clinical-stage biotech company dedicated to the development of best-in-class immunotherapeutics for the brain. A global company headquartered in Dublin, Ireland, with operations in Taiwan and the United States, UNS was founded to address the social and economic burden of Alzheimer’s and other neurodegenerative diseases and seeks to rapidly advance candidates into and through clinical trials with the goal of delivering breakthrough treatments to patients. For more information please visit www.unitedneuroscience.com.

SOURCE: United Neuroscience