Positive Phase 1 Results for Parkinson’s Immunotherapy UB-312

In a recent development, Vaxxinity, Inc., a biopharmaceutical firm listed on NASDAQ under the ticker VAXX, has reported encouraging clinical trial outcomes for its UB-312 drug candidate, specifically designed for treating Parkinson’s disease (PD). The results were showcased by Jean-Cosme Dodart, the company's Senior Vice President of Research, at the AD/PD™ 2024 conference, which took place both online and in Lisbon, Portugal, from March 5 to March 9, 2024.

The drug candidate, UB-312, represents a novel approach in immunotherapy, targeting aggregated forms of the protein alpha-synuclein (aSyn), which is associated with PD and related conditions. The Phase 1 clinical trial, a collaborative effort funded by The Michael J. Fox Foundation and involving Vaxxinity, the Mayo Clinic, and UTHealth Houston, aimed to analyze cerebrospinal fluid (CSF) samples from patients and to study the drug's impact on aSyn levels.

The study found that UB-312 induced antibodies that selectively bound to aggregated aSyn, with minimal interaction with the normal form of the protein. In the high-dose group receiving UB-312, there was a significant 20% reduction in CSF aSyn levels post-treatment, contrasting with a 3% increase in the placebo group. Additionally, patients with detectable antibodies in their CSF showed improvements in daily living activities, as measured by the MDS-UPDRS II scale, suggesting a potential correlation between aSyn reduction and clinical improvement.

Lou Reese, the Co-Founder and Executive Chairman of Vaxxinity, expressed optimism about the potential of UB-312 to revolutionize Parkinson’s treatment and prevention, hinting at a disease-modifying therapy that could offer substantial benefits to patients in the near term.

The positive results were part of the trial's second phase, involving 20 PD patients, with the company anticipating the publication of these findings in a peer-reviewed journal. The first phase of the trial, involving healthy individuals and published in Movement Disorders in 2022, demonstrated the drug's safety and ability to generate an immune response.

Vaxxinity is dedicated to developing innovative synthetic peptide immunotherapies that could transform the treatment of chronic diseases, including Alzheimer’s, migraines, and hypercholesterolemia, as well as contributing to a COVID-19 vaccine initiative. The company's mission is to make healthcare more accessible globally by challenging the current paradigm of monoclonal antibody treatments, which are often costly and difficult to administer.

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