Policy & Regulation
First Patient in Phase 2 Outpatient Study of Brequinar to Treat COVID-19
20 November 2020 - - US-based biotechnology company Clear Creek Bio, Inc has dosed the first patient in the CRISIS2 study, a Phase 2 clinical study evaluating brequinar for the treatment of COVID-19, the company said.

The randomized, open label, multi-center study will enroll up to 100 non-hospitalized patients who have a positive SARS-CoV-2 test and are symptomatic to assess the antiviral activity, safety, and tolerability of brequinar.

Brequinar is an orally available, potent, and selective small molecule DHODH inhibitor that has been shown in vitro to inhibit viral replication of SARS-CoV-2 as well as a broad spectrum of RNA viruses.

Participants will receive the current standard of care and will be treated once daily for five days with either brequinar or a matching placebo.

Clear Creek Bio is a private biotech company focused on developing novel therapies to address infectious disease and cancer.

The company's lead drug candidate, brequinar, is a dihydroorotate dehydrogenase (DHODH) inhibitor with high potency and short half-life.

In addition to its potential as a broad spectrum antiviral, the company is evaluating brequinar as a potential treatment for acute myeloid leukemia.