Vaxxinity announces Phase 1 Part B trial of UB-312 met primary objectives

Vaxxinity announced positive results from Part B of its Phase 1 clinical trial of UB-312, an investigational vaccine for Parkinson’s disease, demonstrating UB-312 was well-tolerated and induced anti-alpha-synuclein (aSyn) antibody responses in participants with early PD, meeting the primary objectives of the trial. The Phase 1 placebo-controlled, double-blind clinical trial of UB-312 consisted of two parts: Part A tested escalating doses of UB-312 versus placebo in 50 healthy volunteers aged 40 to 85 years, and Part B tested two doses of UB-312 versus placebo in 20 age-matched subjects with early PD, both conducted at the Centre for Human Drug Research. Results from Part A, published in Movement Disorders in 2022, suggested that UB-312 is highly immunogenic, with all individuals in the target dose group showing detectable anti-aSyn antibodies in both serum and cerebrospinal fluid. Part B consisted of a 20-week treatment period followed by 24 weeks of observation. This study was conducted to evaluate the safety, tolerability and immunogenicity of UB-312 in patients with PD. Part B end-of-study results are as follows: The primary objectives were met. 92% of patients who completed dosing with UB-312 developed anti-aSyn antibodies. UB-312 was generally safe and well-tolerated with overall adverse event profile similar across UB-312 and placebo groups. Two patients experienced serious adverse events. Only one event was deemed possibly related to the trial, and all SAEs were resolved. Antibodies were also detectable in the CSF.