eClinical Technology and Industy News

Cortexyme Announces Preclinical Data Highlighting Potential Therapeutic Benefits of Atuzaginstat for the Treatment of High-Risk Oral Potentially Malignant Disorders

First-in-class lysine gingipain inhibitor, atuzaginstat, has the potential to reduce the malignant progression of oral potentially malignant disorders (OPMD)

In vitro study results demonstrate that PD-L1 is induced by P. gingivalis and can be blocked by atuzaginstat

Atuzaginstat ready to begin a Phase 2 trial for expansion into high-risk OPMD indication; IND submission expected in the first half of 2022

Excerpt from the Press Release:

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Cortexyme, Inc. (Nasdaq: CRTX), a clinical-stage biopharmaceutical company pioneering upstream therapeutic approaches to improve the lives of patients diagnosed with degenerative diseases, today provided an update on both proprietary preclinical research and peer-reviewed publications supporting the potential of atuzaginstat (COR388) to treat patients with high-risk oral potentially malignant disorders (OPMDs), including oral/head and neck squamous cell cancer (O/HNSCC), high-risk oral pre-malignant dysplasia (PmD), proliferative verrucous leukoplakia (PVL), and carcinoma-in-situ (CIS).

“The infectious bacterium P. gingivalis and its secreted virulence factor proteases, gingipains, may promote the progression of high-risk oral potentially malignant disorders to oral/head and neck cancer and are associated with reduced overall survival rates in O/HNSCC,” said Chris Lowe, Cortexyme’s interim chief executive officer. “Based upon the mechanism of action and non-clinical evidence demonstrating the benefits of atuzaginstat in reducing P. gingivalis-driven tumor growth and pathway activation, as well as PD-L1 expression, Cortexyme sees an opportunity to apply our expertise in gingipain inhibition where P. gingivalis infection plays a central role in disease progression. We look forward to strategically advancing the development of atuzaginstat for the potential treatment of high-risk OPMDs through both internal and external development opportunities.”

Cortexyme is finalizing a Phase 2 trial design for its lysine gingipain inhibitor, atuzaginstat (COR388), as a potential new indication to prevent the development of O/HNSCC. The company has completed a pre-IND (Investigational New Drug application) meeting with U.S. Food and Drug Administration (FDA) and plans to submit an IND to the Division of Oncology 2 in the first half of 2022.

A Role for P. gingivalis in OMPDs

The evidence supporting the development of a gingipain inhibitor for the potential treatment of OMPDs includes the following peer-reviewed publications and proprietary preclinical research:

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