Vaxxinity has announced that its Phase 1 clinical trial of the investigational vaccine UB-312 for Parkinson's disease (PD) has met primary objectives. The vaccine was immunogenic in patients with early PD and generally safe and well-tolerated, demonstrating potential as a candidate for the prevention or modification of PD. UB-312 is an investigational synthetic peptide vaccine that targets toxic forms of aggregated alpha-synuclein to address PD and other synucleinopathies. Alpha-synuclein plays a central role in synaptic functions and regulation of neurotransmitter release.
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 (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