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 FDA has stopped Cortexyme from studying its lead drug any further in Alzheimer's disease and other conditions, dealing a blow to the pipeline and sending shares cratering 30% Wednesday morning. The biotech will now have to focus on its second bet at treating the neurodegenerative disease.
South San Francisco, California-based Cortexyme announced the dosing selection in a presentation of data (PDF) from the split phase trial at the 14th Clinical Trials on Alzheimer’s Disease (CTAD) conference Thursday. The results are mostly what we’ve already heard from the company: Atuzaginstat failed to meet the main goal of the GAIN trial by demonstrating a slowing of cognitive decline.
A novel approach to treating Alzheimer’s disease failed to preserve memory and function in a clinical trial, according to results disclosed Tuesday, but a promising signal in a subgroup of patients has the drug’s inventors optimistic about its future.
Cortexyme, Inc. (Nasdaq: CRTX), a company advancing a pivotal trial in Alzheimer’s disease with top-line data expected by mid-November 2021 and a growing pipeline of therapeutics for degenerative diseases, today announced that the first cohort of healthy participants have been dosed in the Phase 1 clinical trial of its new drug candidate, COR588. COR588 is a second-generation small-molecule lysine-gingipain inhibitor differentiated from the company’s lead drug candidate atuzaginstat (COR388) by its improved pharmacokinetic properties and anticipated once daily oral administration. Delivering on its commitment to bring innovation to high unmet clinical needs, Cortexyme expects COR588 to be targeted for use in the treatment of periodontal disease and other P. gingivalis-related indications.