NDC-0524 is a first-in-class, humanized IgG1 monoclonal antibody designed to selectively neutralize nitrated alpha-synuclein, the pathogenic form of alpha-synuclein shown to play a prominent role in Parkinson’s disease (PD) progression. Nitrated alpha-synuclein is elevated more than twofold in the cerebrospinal fluid and brains of people with Parkinson’s disease, making it both a specific therapeutic target and a measurable biomarker of disease.

NDC-0524 has generated compelling preclinical evidence supporting its potential as a disease-modifying therapy. Across multiple Parkinson’s disease models, the antibody markedly reduced pathological alpha-synuclein aggregation and prevented the spread of disease-associated pathology between brain regions, outperforming an antibody that targets alpha-synuclein more broadly. NDC-0524 also demonstrated greater than 5,000-fold selectivity for nitrated alpha-synuclein, achieved measurable penetration into the central nervous system following intravenous administration, and showed a favorable preclinical safety profile.

NDC-0524 is clinical-stage ready, with IND-enabling activities completed and a first-in-human Phase 1/2a study planned. This single- and multiple-ascending dose study is expected to enroll healthy volunteers and Parkinson’s disease patients who test positive using the Synuclein Seed Amplification Assay (SAA), a highly sensitive PD biomarker that is correlated with levels of nitrated alpha-synuclein. The study is designed to evaluate safety, tolerability, pharmacokinetics, immunogenicity, and biomarker-enabled target engagement and POM (by measuring its effect on synuclein aggregation in SAA) of NDC-0524.

By selectively targeting the pathogenic nitrated form of alpha-synuclein, NDC-0524 has the potential to become a transformative disease-modifying therapy for the more than 10 million people living with Parkinson’s disease, addressing one of the largest unmet needs in neurodegenerative medicine.