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:

Click the button below to read the entire Press Release:

Continue Reading The Press Release

Discover What Sets TrialStat Apart From Ordinary Data Management

Click the image or button below to explore our interactive infographic which illustrates the comprehensive and unique capabilities of the TrialStat eClinical Suite.

Request Your Demo Today!

From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?