Vaxxinity Completes Enrollment in Part B of Phase 1 Trial for Parkinson’s

 Vaxxinity, Inc. (Nasdaq: VAXX), a U.S. company pioneering the development of a new class of immunotherapeutic vaccines, today announced it has completed patient enrollment for Part B of its ongoing Phase 1 clinical trial of UB-312 in Parkinson’s disease (PD). Vaxxinity’s investigational UB-312 vaccine candidate targets pathological forms of alpha-synuclein (aSyn) to treat PD and other conditions such as dementia with Lewy bodies (DLB) and multiple system atrophy (MSA).

“With enrollment now complete in the second part of this two-part study, we are thrilled to take another step forward in our efforts to develop a first-of-its-kind treatment for PD and other synucleinopathies,” said Mei Mei Hu, Chief Executive Officer of Vaxxinity. “We are grateful to the Michael J. Fox Foundation for its support of this ongoing study, and look forward to the end-of-treatment analysis in the second half of this year.”

Vaxxinity also announced that results from Part A of the Phase 1 trial evaluating UB-312 in healthy volunteers were published in Movement Disorders. The article, “A Randomized First-in-Human Study With UB-312, a UBITh® α-Synuclein Peptide Vaccine,” outlines preliminary evidence suggesting UB-312 is well tolerated and induces dose-dependent antibody production, with high titer levels detectable in cerebrospinal fluid (CSF), a key characteristic for tackling diseases of the brain.¹

The Phase 1 clinical trial is a first-in-human, randomized, double-blinded, placebo-controlled study evaluating the potential of UB-312 in PD. The study has completed enrollment of 50 healthy volunteers in Part A, and 20 PD patients in Part B with Hoehn and Yahr stage ≤ III. The primary objectives are to determine safety, tolerability, and immunogenicity of UB-312. The study will also assess exploratory biomarker endpoints for target engagement using protein misfolding cyclic amplification. The clinical trial is being conducted at the Centre for Human Drug Research (CHDR) in the Netherlands, funded through a grant from The Michael J. Fox Foundation and in collaboration with the Mayo Clinic and the University of Texas. An end-of-treatment analysis is expected in the second half of 2022, with full analyses at end of study in 2023.

https://finance.yahoo.com/news/vaxxinity-completes-enrollment-part-b-120000456.html