Clear Creek Bio has dosed the first patient in phase 1 clinical study of brequinar in hospitalised patients with Covid-19.
The company has secured clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application of brequinar to treat Covid-19.
Brequinar is an orally available, potent, and selective small-molecule DHODH inhibitor, which can inhibit host cell de novo pyrimidine biosynthesis that is crucial for DNA and RNA synthesis.
According to the company, in vitro one and in vitro two studies have demonstrated that brequinar has potent antiviral activity against a range of viruses such as SARS-CoV-2.
Clear Creek will recruit up to 24 patients hospitalised with Covid-19 in the randomised, open-label, multi-centre study to evaluate the preliminary efficacy, safety, and tolerability of brequinar.
The company will assign participants in a 1:2 ratio in the study to receive standard of care or standard of care plus five once-daily oral doses of 100mg brequinar.
Clear Creek has designed brequinar to deliver broad-spectrum and mutation-resistant antiviral activity either as a standalone therapy or combined to complement and enhance direct-acting antiviral drugs.
Additional in vitro data has demonstrated that brequinar enabled to increase the increased effects of other antiviral therapies, including nucleoside analogs that are presently being assessed to treat Covid-19.
Clear Creek Bio president and CEO Dr Vikram Sheel Kumar said: “In preclinical studies, brequinar has demonstrated compelling antiviral activity against a broad spectrum of RNA viruses, most importantly SARS-CoV-2.
“With the urgent need today, we are focused on rapidly developing brequinar as a potential treatment for Covid-19.”
Recently, AstraZeneca has initiated a phase 1 trial of a monoclonal antibody combination called AZD7442, which is being developed for the prevention and treatment of Covid-19.