Romark Initiates Trial of NT-300 for COVID-19

Romark announced the initiation of a Phase 3 clinical trial of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets) as a treatment for mild or moderate COVID-19.

"As the COVID-19 pandemic continues to take a toll on our collective health, economy and well-being, we are pleased to broaden our NT-300 COVID-19 clinical program through the initiation of a third trial evaluating NT-300 as a treatment in addition to our two ongoing prophylactic trials," said Jean-François Rossignol, M.D., Ph.D., Chief Medical and Scientific Officer of Romark. "Along with vaccines and treatments for severe illness, oral treatments that can be given outside of a hospital setting to prevent infection or used as soon as symptoms appear to reduce the duration of illness and prevent hospitalizations are desperately needed. Given the broad spectrum antiviral properties of NT-300, this research is an important step in our understanding of its potential impact on COVID-19 in its early stages."

The multicenter, randomized, double-blind trial will study up to 800 people twelve years and older with fever and respiratory symptoms consistent with COVID-19. These participants will be given either NT-300 or placebo twice daily for five days. Efficacy analyses will examine those participants who have laboratory-confirmed SARS-CoV-2 infection. The primary endpoint is a reduction in the time to sustained response (a measure of recovery time) compared with placebo, and the secondary endpoint is a reduction in the rate of progression to severe COVID-19 illness compared with placebo.

Earlier this year, Romark initiated two Phase 3 clinical trials for the prevention of COVID-19 and other viral respiratory illnesses in high-risk populations, including elderly residents of long-term care facilities and healthcare workers. Romark anticipates sharing results from these studies later this year.

In cell cultures, the active ingredient in NT-300, nitazoxanide, inhibits replication of a broad range of respiratory viruses, including the SARS-CoV-2 virus that causes COVID-19. Nitazoxanide has also been shown to inhibit replication of SARS, MERS and other coronaviruses as well as influenza viruses, rhinoviruses, parainfluenza viruses, RSV and other respiratory viruses in cell culture studies. The broad-spectrum antiviral activity of nitazoxanide is attributed to its interference with human cellular pathways that the virus exploits to replicate, rather than to a virus-targeted mechanism.