NDC-0524 / Nitrase Therap - LARVOL DELTA

PRECLINICAL EFFICACY AND DEVELOPMENT OF AN ANTI-NITRATED ALPHA SYNUCLEIN ANTIBODY FOR THE TREATMENT OF PARKINSON'S DISEASE (ADPD 2025) - "Based on this strong in vivo efficacy, preclinical development of NDC-0524 is underway to enable First-in-Human (FIH) studies in 2025...Conclusions These consistent efficacy findings across multiple mouse models strongly support nSyn's role as a pathogenic subspecies driving aggregation and spread in models of PD, highlighting the potential of targeting nSyn as a therapeutic strategy in the clinic. To this end, we have advanced a development candidate, NDC-0524, into IND-enabling studies."

Preclinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Nitrase Therapeutics Presents Preclinical Data from Multiple Studies Demonstrating Its Antibody Prevents Pathological Spread of Parkinson's Disease in an Oral Presentation at the Alzheimer's Disease and Parkinson's Disease (AD/PD) Conference (GlobeNewswire) - "The presentation reported data from four different spread models of Parkinson's Disease (PD) which showed that the murine parental of NDC-0524 consistently achieved superior efficacy, demonstrating a statistically significant reduction or elimination of synuclein spread across regions of the brain. Additionally, it showed superior reduction in the transmittal of pathogenic synuclein compared to murine parental for prasinezumab, an antibody that primarily binds to the normal/non-nitrated form of alpha-synuclein (α-syn)....NDC-0524 is expected to enter into a first-in-human Phase 1/2a randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study in healthy volunteers and PD patients in 2025."

New P1/2 trial • Preclinical • Parkinson's Disease

NDC-0524 for Parkinson’s may enter clinical testing in late 2025 (Parkinson's Foundation) - "NDC-0524, an experimental antibody that Nitrase Therapeutics is developing as a treatment for people with Parkinson’s disease, is expected to enter clinical testing in the fourth quarter of 2025, or before the end of the year..."

New trial • Parkinson's Disease

Nitrase Therapeutics Presents Preclinical Data Demonstrating Antibody Prevents Spread of Pathology of Parkinson’s Disease at SfN’s Neuroscience 2024 Scientific Congress (GlobeNewswire) - "Nitrase Therapeutics, Inc...today announced a poster titled 'NTX101, an Antibody Against Nitrated Alpha-Synuclein, Prevents Spread of Pathology in Multiple Pre-Clinical Parkinson Models' (abstract # 6647) was presented at the Society for Neuroscience’s (SfN) Neuroscience 2024 congress taking place in Chicago from October 5-9, 2024. The antibody, which is designed to block the pathological spread of nitrated alpha synuclein (-synuclein), has demonstrated efficacy in multiple in vivo Parkinson’s disease (PD) spread models, further supporting the role of nitrated -synuclein as a pathogenic subspecies driving aggregate spread of PD in the brain...'Based on our impressive body of data showing efficacy in multiple highly-translational Parkinson’s models, we are advancing our humanized antibody NDC-0524 through IND-enabling studies to initiate a clinical study in 2025.'"

Preclinical • CNS Disorders • Parkinson's Disease

Nitrase Therapeutics Presented Data on the Importance of Synuclein Nitrase on the Synaptic Activity of Differentiated Dopaminergic Neurons at the Society for Neuroscience (SFN) Conference (GlobeNewswire) - "Nitrase Therapeutics, Inc...announced the company presented the poster titled 'Synuclein Nitrase, a Novel Enzyme that Catalyzes Nitration of Synuclein, Modulates Dopaminergic Neuron Activity'...at the Society for Neuroscience 2022 (SFN) conference held from November 12-16, 2022 in San Diego, CA. The company has identified a novel enzyme, Synuclein Nitrase, that catalyzes nitration of alpha-synuclein, which has been implicated in dopamine neuron pathologies in Parkinson’s disease (PD). In preclinical studies, Nitrase examined the effect of knocking out Synuclein Nitrase on the survival, growth and electrical activity of differentiated dopaminergic neurons (iDAs) derived from human iPSC lines from both non-PD and familial PD (fPD) patients. Data showed that fPD iDAs had higher weighted mean firing rate and higher network burst frequency, but reduced synchrony as compared to non-PD iDAs. Knocking out Synuclein Nitrase increased synchrony in PD and non-PD..."

Preclinical • CNS Disorders • Parkinson's Disease