Vaxxinity, Inc. announced that the first patient with Parkinson's disease (PD) has been dosed with UB-312 in Part B of a double-blinded, placebo-controlled Phase 1 clinical trial, following completion of Part A of the Phase 1 trial in healthy volunteers. UB-312 is a synthetic peptide vaccine targeting toxic forms of aggregated a-synuclein (aSyn), a protein that plays a central role in synaptic functions and regulation of neurotransmitter release at the synapse. Mutations of aSyn increase the risk of developing PD and other synucleinopathies, including dementia with Lewy bodies (DLB) as well as multiple system atrophy (MSA).

UB-312 was granted an orphan designation for MSA by the European Medical Agency (EMA). The study is enrolling up to 20 patients with PD, Hoehn and Yahr stage = III, at the Center for Human Drug Research in the Netherlands. Patients will be enrolled in one of two dosing cohorts with the primary objectives of safety and immunogenicity.

The study will also assess exploratory biomarker endpoints for target engagement including Protein Misfolding Cyclic Amplification, supported by a grant from the Michael J. Fox Foundation, and in collaboration with Mayo Clinic and University of Texas.