A pharmaceutical company announced the start of two clinical trials of an anti-viral medication to be used in the COVID-19 fight.
Romark Pharmaceuticals, headquartered in Tampa, Florida, said the testing would be focused first on high-risk populations, including elderly residents of long-term care facilities and healthcare workers.
The drug candidate, NT-300 (nitazoxanide extended-release tablets), is intended for the prevention of COVID-19 and other viral respiratory illnesses.
“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,” said in a statement from Jean-François Rossignol, M.D., Ph.D., Chief Medical and Scientific Officer of Romark.
One of the main ingredients of this experimental drug is Nitazoxanide. Marc Ayers, President and Chief Executive Officer of Romark Pharmaceuticals, told LTC NEWS that more than 400 million people – including the elderly and people with pre-existing conditions – have been treated with Nitazoxanide. The primary reported side effects have been abdominal pain, headache, chromaturia, and nausea.
Ayers said there had been no important safety concerns concerning the use of the product for the treatment of intestinal parasitic infections in the elderly population or persons with pre-existing health issues. NT-300 is formulated differently and contains a different dosage.
In clinical trials of NT-300, the most common adverse events have been diarrhea and chromaturia, and the side effects do not differ based upon age, according to Ayers.
“There have been no significant safety concerns with respect to use of the product in the elderly population or persons with pre-existing health issues,” he explained.
Two Trials with High-Risk Groups
The company is conducting two clinical trials. One is focused on those age 65+ who live in long-term care facilities, and the other will enroll 800 U.S. healthcare workers (aged 18 to 64 years old) who are at risk of exposure to the coronavirus. They are first putting their full attention on the high-risk populations.
Romark says they plan to begin enrolling patients in these two trials in May. The company says the completion will depend on when full enrollment is achieved, but it could be as soon as August.
“If the trials show NT-300 is effective, we will work with the FDA to apply for approval very soon after the completion of the trials,” according to Ayers.