Romark Initiates Phase 3 Clinical Trials Of NT-300 For COVID-19

Romark Laboratories, L.C. announced today it will initiate two clinical trials of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets) for prevention of COVID-19 and other viral respiratory illnesses in high-risk populations, including elderly residents of long-term care facilities and healthcare workers.

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.^1-4 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.^2-4 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.^2,4

“These new clinical trials we have initiated aim to investigate the safety and efficacy of NT-300 in preventing viral respiratory infections, with particular emphasis on COVID-19,” said Jean-François Rossignol, M.D., Ph.D., Chief Medical and Scientific Officer of Romark. “Prevention is an important strategy in controlling infectious diseases and could be especially important in the context of the ongoing COVID-19 pandemic. The ability of NT-300 to thwart infection of human cells by viruses supports an investigation for its use early in the course of infection to prevent disease. We look forward to learning more about its potential for managing COVID-19 and other serious viral illnesses.”

The first trial is designed to enroll 800 elderly residents of long-term care facilities following reports of the first case of COVID-19 at the sites. The second will enroll 800 healthcare workers who are at risk of exposure to the SARS-CoV-2 coronavirus. In both studies, participants will receive either NT-300 or placebo for six weeks, and the primary endpoint is the rate of COVID-19 illness for NT-300 versus placebo.

In addition to these prevention studies, Romark plans to conduct a third clinical trial of NT-300 for the early treatment of COVID-19 and other viral respiratory illnesses.

Romark has been studying the potential of NT-300 in emerging and drug-resistant viruses for nearly a decade, and its development program has been supported by the U.S. Department of Health and Human Services.^†

The only drugs approved for treating viral respiratory illnesses are direct-acting antiviral drugs such as oseltamivir (Tamiflu^®) for treating and preventing influenza, and these drugs can be associated with problems of resistance. There are no approved treatments for other viral respiratory illnesses caused by rhinoviruses, enteroviruses, coronaviruses, parainfluenza viruses, respiratory syncytial viruses (RSV), human metapneumovirus or bocavirus.

-PR Newswire