United Neuroscience (UNS) has reported positive results from the Phase I clinical trial of UB-311 for the treatment of patients suffering from Alzheimer’s disease (AD).
UB-311 is a synthetic peptide vaccine designed to target N-terminus of beta-amyloid (Aβ), trigger high B-cell specific responses and inhibit T-cell inflammation.
The results showed a 100% response rate and high anti-Aβ antibody titers, while the vaccine was found to possess a favourable safety and tolerability profile with no major adverse events.
The Phase I trial evaluated the vaccine in 19 patients with mild-to-moderate AD.
The subjects were monitored until week 48, following the administration of three doses of vaccine, one each at enrolment, four weeks and 12 weeks.
UNS chief medical officer Ajay Verma said: “Our positive Phase I clinical trial results show that our active vaccination approach against endogenous pathogenic proteins has an acceptable safety and tolerability profile in patients, which was the primary endpoint of the study.
“The ability of our platform to break self-tolerance in patients and safely elicit therapeutic autoantibodies, or endobodies as we like to refer to them, suggests that we are on the right path and have overcome prior challenges.
“We believe our endobody vaccine approach could provide therapeutic and prophylactic treatment for Alzheimer’s disease, as well as many other neurodegenerative diseases.”
A subgroup of mild AD patients above 60 years old showed stabilisation or improvement in three cognitive scales from baseline to week 48.
UB-311 is being further evaluated in a Phase II active immunotherapy trial, with results expected by mid next year.