Romark eyes FDA okay for COVID antiviral despite mixed trial results
A phase 3 trial of Romark's antiviral drug NT-300 has missed the main objective in a phase 3 trial in mild to moderate COVID-19 patients, but could still have a shot at emergency use authorisation (EUA), according to the US company.
The Florida-based firm has just released top-line results from the 1,092-patient study, showing that patients treated NT-300 – an orally-active, long-acting formulation of the established drug nitazoxanide – didn’t differ significantly from a placebo group in the time it took to recover from COVID-19.
The median time to sustained response was 13 days in both groups, although a subgroup analysis of people with mild symptoms found a three-day reduction with Romark's drug.
The company is highlighting a secondary finding in the trial, which showed that NT-300 reduced progression to severe disease in all evaluable patients by 85% compared to placebo. Severe disease was seen in 0.5% of the NT-300 group (one patient), compared to 3.5% of those taking placebo.
That is at the top end of the range of reductions achieved with monoclonal antibodies targeting SARS-CoV-2 that have been granted EUAs by the FDA, it says. So far, Eli Lilly's bamlanivimab and etesevimab and Regeneron's casirivimab and imdevimab are the only antibody drugs cleared by the US regulator for this use.
At the moment, the only antiviral drug approved for use in COVID-19 is Gilead Sciences' Veklury (remdesivir), which has to be administered by intravenous infusion and is only used for hospitalised patients aged 12 or over.
A spokesperson for Romark said that there is a need for an oral medicine that can be taken at home, after COVID-19 symptoms start to appear, to protect people from progressing to severe disease.
If cleared, NT-300 could be used in a similar way to Roche's Tamiflu (oseltamivir), a drug used to reduce the time to recovery for people with flu, she suggested. Based on the findings, Romark says it is working with the FDA to try to get an EUA for NT-300.
“Along with vaccines and treatments for severe illness, oral treatments that can be administered outside of a hospital setting to effectively reduce disease progression are urgently needed," said Romark's chief medical officer Jean-François Rossignol.
"Our results compare favourably with therapeutics that have been granted [EUAs] for use in a hospital setting in patients at high risk of developing serious COVID-19,” he added.
Romark started testing the drug for COVID-19 after lab studies showed it was able to inhibit the replication of a broad range of respiratory viruses, including SARS-CoV-2.
NT-300 is also in phase 3 development for treating and preventing acute respiratory illnesses caused by a broad range of respiratory viruses, including influenza, parainfluenza and respiratory syncytial virus (RSV).
Romark already markets an immediate-release formulation of the drug as Alinia for the parasitic diseases Cryptosporidium parvum and Giardia lamblia.
