United Neuroscience (UNS) has reported positive top-line results from its Phase IIa clinical trial evaluating UB-311 in patients with Alzheimer’s disease.
The trial met its primary endpoint of safety and immunogenicity with a 96% response rate.
Secondary endpoints of the trial also achieved favourable results, but not statistically significant data among the study patients.
The trial’s secondary endpoints included amyloid PET burden, clinical dementia rating sum of boxes (CDR-SB), Alzheimer's disease cooperative study activities of daily living inventory (ADCS-ADL) and mini–mental state examination (MMSE).
United Neuroscience research and development executive vice-president Peter Powchik said: “The positive results show that we can safely raise and maintain anti-Aβ antibody titers in a predictable and sustained manner.
“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.”
UNS’ Phase IIa trial was conducted in a double-blinded, placebo-controlled setting. It examined the safety and immunogenicity of two different dosing regimens of UB-311.
Subjects from the trial will also take part in a long-term extension study and will continue to receive UB-311.
United Neuroscience CEO Mei Mei Hu said: “These early results suggest a clinical response and support the continued and rapid development of UB-311.
“The intent of this Phase IIa study was to acquire directional information on the safety, tolerability and therapeutic potential of UB-311 in patients with Alzheimer's disease.”