- NDC-0524 is a First-in-class Monoclonal Antibody with High Selectivity for Nitrated Alpha-synuclein (nSyn) and is Expected to Begin a Randomized Phase 1/2a Trial in the Fourth Quarter of 2025
- Elevated nSyn is Found in Patients with Parkinson’s Disease, and Secreted nSyn Levels Suggest Pathogenic Link to the Spread of the Disease
BRISBANE, Calif., April 01, 2025 (GLOBE NEWSWIRE) -- Nitrase Therapeutics, Inc., a biopharmaceutical company deploying its NITROME platform to build a pipeline of therapies targeting nitrases (and their substrates), a new class of enzymes discovered in-house that are implicated in a broad variety of diseases, today presented an oral presentation titled, “Preclinical Efficacy and Development of an Anti-Nitrated Alpha Synuclein Antibody for the Treatment of Parkinson’s Disease” (abstract #2030; ID #2734) at the Alzheimer’s Disease and Parkinson’s Disease (AD/PD) conference taking place in Vienna, Austria from April 1-5, 2025. 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).
“These data demonstrate that our antibody neutralizes secreted, nitrated synuclein, helping to prevent the spread of Parkinson’s pathology from diseased neurons to healthy ones,” said Irene Griswold-Prenner, Ph.D., chief executive officer of Nitrase Therapeutics. “These promising findings were highly consistent across multiple, separately conducted in vivo studies and for different regions of the brain. The presence of aggregated nitrated alpha-synuclein in the neurons of PD patients has been well-illustrated by many in the neurodegeneration field, and it has also been previously shown to induce dopaminergic neuronal death and motor deficits in mice. At Nitrase, we are developing two PD treatments to address this disease pathology – NDC-0524 to reduce cell-to-cell disease transmission and a synuclein nitrase inhibitor to stop the generation of nitrated synuclein.”
The in vivo efficacy studies were conducted using PD models that recapitulate the pathophysiological spread seen in brains with the disease. To confirm the effectiveness of the anti-nSyn antibody in preventing the pathological spread in the brain, aggregates of synuclein or phosphorylated α-syn within proximal and distal brain regions were measured by an independent algorithm. In four varied types of spread models, the anti-nSyn antibody significantly reduced the α-syn aggregates by as much as 88% (p<0.0001) and outperformed the murine parental for prasinezumab (31% reduction, not significant) at an equivalent dose. These consistent efficacy findings across multiple in vivo models evaluating different regions of the brain strongly support the pathological role of nSyn and the potential of NDC-0524 as a treatment for PD.
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. The study is designed to evaluate the safety, tolerability, pharmacokinetic profile, biomarker-enabled target engagement/proof-of-mechanism and immunogenicity of NDC-0524.
About NITROME Platform and Nitrases
Nitrase Therapeutics’ proprietary NITROME Platform leverages the company’s unique knowledge of protein nitration to unlock the full therapeutic potential of nitrases by identifying novel nitrases, their nitro-substrates and their role in particular diseases. Long believed to be a pure chemical reaction (like reactive-species oxidation) and therefore a poor drug target, nitration has been an elusive area for drug development. Nitrase Therapeutics’ scientists were the first to identify the enzyme dependent nature of nitration (vs. chemical) and elucidate its potential as a drug target. The company discovered that the nitration of proteins is actually a protein-catalyzed and exquisitely selective process regulated by nitrase enzymes and that the nitro-substrates can be highly validated therapeutic targets. These insights enable the company’s unique understanding of the role of protein nitration in age-dependent diseases.
About Nitrase Therapeutics, Inc.
Nitrase Therapeutics is a pioneering biopharmaceutical company deploying its unique NITROME platform to unlock the therapeutic potential of nitrases, a new class of enzymes that it discovered, to develop a pipeline of therapies against a broad range of diseases. The medicines that Nitrase Therapeutics is developing will target these enzymes or their substrates and potentially help slow or halt the progression of numerous diseases in which nitrases and nitro-substrates play a role, including Parkinson’s, cancer, immunological and fibrotic diseases. Nitrase Therapeutics (under the former name Nitrome Biosciences) has been widely recognized and has won multiple awards including the prestigious Target Advancement grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF). Nitrase Therapeutics is located in Brisbane, CA, and its investors include Sofinnova Partners, Dementia Discovery Fund, Bristol Myers Squibb, AbbVie Ventures, Mission Bay Capital and Alexandria Venture Investments. For more information, please visit the company’s website at www.nitrasetx.com.
Investor and Media Contacts
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