Clear Creek Bio Doses First Patient in Phase 2 Outpatient Study of Brequinar to Treat COVID-19

Clear Creek Bio, Inc. announced today that the company has dosed the first patient in the CRISIS2 study, a Phase 2 clinical study evaluating brequinar for the treatment of COVID-19. 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.¹ Participants will receive the current standard of care and will be treated once daily for five days with either brequinar or a matching placebo.

"There's an exceptional need for oral antiviral treatments that are suitable for outpatient treatment, and we are pleased to advance brequinar into a Phase 2 clinical trial for the treatment of COVID-19," said Vikram Sheel Kumar, M.D., Chief Executive Officer of Clear Creek Bio. "We believe brequinar's unique drug profile, with oral bioavailability and high potency, supports its development as an oral, once-daily treatment for COVID-19."

"In addition to its demonstrated in vitro antiviral activity against SARS-CoV-2, brequinar has been previously studied in more than 1,000 patients for other medical conditions," said John C. Pottage, Jr., M.D., Chief Medical Advisor of Clear Creek Bio. "The purpose of this clinical trial is to establish whether brequinar has the antiviral safety and tolerability profile in patients infected with SARS-CoV-2 that can support the further clinical development of brequinar for the treatment of COVID-19."

For more info on the clinical trial, please visit https://clinicaltrials.gov/ct2/show/NCT04575038.

About Clear Creek Bio

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. For more information, please visit www.clearcreekbio.com.

References

1. Rui Xiong, et al. Novel and potent inhibitors targeting DHODH are broad-spectrum antivirals against RNA viruses including newly-emerged coronavirus SARS-CoV-2. August 2020. https://doi.org/10.1007/s13238-020-00768-w

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