Anti-amyloid drug shows significant immune response in adults with mild Alzheimer’s

Key takeaways:

• The study featured 43 adults with mild Alzheimer’s randomized who received UB-311 or placebo for 78 weeks.
• The antibody response rate was 93% for treatment groups with minimal adverse effects.

Treatment with an investigational anti-amyloid therapeutic for adults with mild Alzheimer’s disease was safe, efficacious and demonstrated a significant immune response up to 78 weeks, per a study published in EBioMedicine.

“An intervention that could slow the progression of early disease would delay the onset of disability association with Alzheimer’s,” Hui Jing Yu, PhD, senior director of clinical development at Vaxxinity Inc., a biotechnology firm, and colleagues wrote.

Yu and fellow researchers sought to examine safety, efficacy and immunogenicity of novel intramuscular anti-amyloid therapeutic UB-311 in adults with Alzheimer’s disease.

Their phase 2a study was a 78-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial conducted within four hospitals in Taiwan. A total of 43 adults with mild AD were randomized 1:1:1 to receive either seven quarterly (weeks 24, 36, 48, 60) intramuscular injections of UB-311, five doses of UB-311 with two doses of placebo in a three-dose priming series with boosting at weeks 36 and 60, or seven doses of placebo at baseline and at weeks 4, 12, 24, 36, 48 and 60.

The study itself was comprised of three parts: screening which took up to 6 weeks, a 60-week double-blind, randomized treatment period and the 18-week blinded follow up.

Cognitive effects of dosage were examined via five standard tests, while safety was assessed in all participants who received at least one dose of UB-311.

A total of 41 of 43 participants remained throughout the full 78 weeks of treatment.

UB-311 was found to be safe, well-tolerated and generated a robust immune response, with a 97% antibody response rate, maintained at 93% by the end of the study across both therapeutic treatment groups. The most recorded treatment-emergent adverse events were injection-site pain (14 TEAEs in seven participants), amyloid-related imaging abnormality with microhemorrhages and hemosiderin deposits (12 TEAEs in six participants) and diarrhea (five TEAEs in five participants).

“The successful completion of this study represents an important milestone ... and supports the continued development of UB-311 for treatment of Alzheimer’s disease,” Yu and colleagues wrote.