A phase 1b clinical trial of UB-312 in subjects with synucleinopathies

Brief description of study

The purpose of this research is to evaluate the safety and tolerability of an investigational vaccine (UB-312), in patients with Multiple System Atrophy (MSA) and Parkinson’s disease (PD). UB-312 is investigational meaning it is not FDA-approved.

UB-312 is a new vaccine that is being developed for the treatment of MSA and PD. Patients with MSA and PD present with clumps of a protein, alpha-synuclein, in the brain. It is believed that these protein clumps have a toxic effect on the nerve cells in the brain and thereby lead to increased MSA and PD symptoms.

The purpose of the UB-312 vaccine is to generate a response by the immune system against these proteins. This immune response can be evaluated by measuring antibodies. Antibodies are proteins of the immune system that identify and neutralize specific particles. We expect that antibodies against alpha-synuclein will be measurable in the blood and cerebrospinal fluid (fluid that surrounds the brain and spinal cord). By activating the body’s immune system, the body itself might be able to decrease protein clump formation. This could potentially slow down the disease progression.

The purpose of this study is to investigate how safe and tolerable the vaccine is and how the generation of antibodies against alpha-synuclein goes when it is administered to MSA and PD patients.

Clinical Study Identifier: s22-00631
ClinicalTrials.gov Identifier: NCT05634876
Principal Investigator: Horacio Kaufmann.

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