Clear Creek Bio has dosed the first patient in the Phase II CRISIS2 study of brequinar to treat patients with Covid-19 in the outpatient setting.
Orally available, potent brequinar can selectively inhibit small molecule dihydroorotate dehydrogenase (DHODH).
The randomised, open-label, multi-centre study will enrol up to 100 non-hospitalised patients who tested positive for Covid-19 and have at least one symptom. It will evaluate the antiviral activity, safety, and tolerability of brequinar.
Study subjects will be given a once-daily dose of brequinar or placebo for five days apart from the current standard of care.
Clear Creek Bio CEO Vikram Sheel Kumar said: “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 II clinical trial for the treatment of Covid-19.
“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.”
The DHODH inhibitor has shown to potentially stop viral replication of RNA viruses including SARS-CoV-2 in vitro.
Clear Creek Bio chief medical advisor John Pottage said: “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.
“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.”
In September, the US Food and Drug Administration (FDA) granted investigational new drug (IND) status to brequinar for treating patients with Covid-19 and initiated the dosing of participants in the Phase I study.