Vaxxinity, Inc. announced positive results from Part B of its Phase 1 clinical trial of UB-312, an investigational vaccine for Parkinson's disease (PD), 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. Importantly, these antibodies crossed the blood brain barrier, and the data also suggest potential target engagement in the periphery, where pathological alpha-synuclein is known to be concentrated. Together these results support the further development of UB-312 in a Phase 2 clinical trial.

The accumulation and aggregation of misfolded aSyn in the brain is considered to be a key factor in the development and progression of PD. 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 against placebo in 20 age-matched subjects with early PD (Hoehn & Yahr stage = III), both conducted at the Centre for Human Drug Research (CHDR), an independent institute in the Netherlands. 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 (CSF).