TAMPA, Florida, April 14, 2021 / PRNewswire
Romark Laboratory today announced initial results from a Phase 3 clinical trial of its investigational new drug candidate NT-300 ( nitazoxanide extended-release tablets , 300 mg) versus placebo as a treatment for or moderate COVID-19. Based on the findings, Romark is working with the US Food and Drug Administration (FDA) and plans to apply for an Emergency Use Authorization (EUA).
In the primary endpoint analysis, the median time to sustained response (a measure of recovery time) was similar for subjects treated with NT-300 compared to placebo (approximately 13 days).
In the predefined subgroup of patients with mild disease, the median time to sustained response was reduced by 3.1 days with NT-300 (10.3 days, n = 116) versus placebo (13.4 days, n = 129).
In the analysis of the key secondary endpoint, treatment with NT-300 was associated with an 85% reduction (0.5% of patients treated with NT-300 vs. 3.6% of patients treated with placebo) in progression to severe disease (respiratory failure at rest with SpO2 ≤93% on room air or PaO2/FiO2 <300).
Only one person treated with NT-300 progressed to severe COVID-19 disease.
In the predefined subgroup at high risk for severe disease according to CDC criteria, 7/126 (5.6%) of placebo-treated subjects experienced severe disease compared with 1/112 (0.9%) of subjects treated with NT-300.
"Given the enormous cost of the COVID-19 pandemic and the continued risk to public health, we are pleased that the results of these clinical trials show a convincing reduction in progression to severe COVID-19 with early treatment with NT-300 "said Jean-François Rossignol. , M.D., Ph.D., Chief Medical and Scientific Officer at Romark.
"Along with vaccines and treatments for serious diseases, oral treatments that can be administered outside the hospital setting are urgently needed to effectively reduce disease progression. Our results compare favorably with treatments that are has granted Emergency Use Authorization for use in a hospital setting in patients at high risk of developing severe COVID-19."
The multicenter, randomized, double-blind trial (NCT04486313) studied 1,092 people aged 12 years and older with respiratory symptoms consistent with COVID-19. Participants were enrolled at outpatient centers in the United States within 72 hours of symptom onset and were treated with two tablets of NT-300 or placebo twice daily for five days. Efficacy analyzes focused on the 379 participants who had laboratory-confirmed SARS-CoV-2 infection at baseline.
NT-300 was well tolerated. The only adverse event that occurred in more than 2% of subjects was diarrhea (3.4% in the NT-300 group versus 2.2% in the placebo group). There were no significant differences in adverse events between the two treatment groups.
The full findings of the study were submitted for publication in a peer-reviewed journal.
Results from an additional clinical trial for the prevention of COVID-19 and other viral respiratory diseases in high-risk populations, including healthcare workers, are expected by mid-year.
About nitazoxanide
Nitazoxanide, the active ingredient in NT-300, was originally developed to treat intestinal protozoal infections caused by Cryptosporidium parvum and Giardia lamblia . Laboratory studies demonstrating broad-spectrum antiviral activity led to the development of nitazoxanide as a broad-spectrum host-directed antiviral drug.
In cell cultures, the active ingredient in NT-300, nitazoxanide, inhibits the maturation of the SARS-CoV-2 spike protein, which in turn blocks the formation of SARS-CoV-2 syncytia. Nitazoxanide has also been shown to inhibit the 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 a virus-directed mechanism.
Laboratory studies to evaluate the potential for resistance of Influenza A virus to tizoxanide, the active circulating metabolite of nitazoxanide, have failed to select resistant viruses, suggesting a low potential for viral resistance.
Other studies have shown that tizoxanide suppresses the secretion of proinflammatory cytokines that are upregulated by viral respiratory infections, including IL-6.5. The antiviral and anticytokine activities of nitazoxanide are attributed to the modulation of mitochondrial function and consequent effects on cellular signaling pathways.
About NT-300
NT-300 (nitazoxanide extended-release tablets) is an investigational broad-spectrum antiviral drug in Phase 3 clinical development to treat and prevent acute respiratory diseases caused by a wide range of seasonal, emerging, or respiratory viruses. drug resistant, including influenza viruses, rhinoviruses, other enteroviruses, coronaviruses, parainfluenza viruses, respiratory syncytial virus (RSV), human metapneumovirus or bocavirus.
NT-300 tablets, administered orally, are designed to deliver antiviral concentrations of drug to the respiratory tract over a twice-daily dosage. The 600 mg dose was selected based on a dose-ranging clinical trial conducted in outpatients with influenza.
To date, clinical trials of NT-300 for the treatment of viral respiratory diseases have included more than 7,000 patients. The NT-300 clinical development program has been designed to provide strong evidence of efficacy to support the use of NT-300 and ensure maximum benefit for the large number of patients suffering from these diseases.
About Romark
Romark is a vertically integrated research pharmaceutical company focused on the discovery, development and delivery of innovative new medicines, primarily in the field of infectious diseases. Romark has operations in the United States, Puerto Rico and Europe, and conducts research and development and markets its products globally.
Romark is a leader in the development of new medicines to treat a wide range of seasonal, emerging and drug-resistant viral respiratory diseases. It is also developing a new product aimed at inducing functional cure of chronic hepatitis B. The products discovered, developed and marketed by Romark have been used to positively impact the lives of more than 400 million people around the world.
