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

Nitazoxanide, the active ingredient of NT-300, was originally developed for treating intestinal protozoan 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. Laboratory studies to evaluate the potential for resistance of influenza A virus to tizoxanide have been unable to select for resistant viruses, suggesting a low potential for viral resistance. Other studies have shown tizoxanide suppresses secretion of pro-inflammatory cytokines that are upregulated by viral respiratory infections including IL-6.5?The antiviral and anti-cytokine activities of nitazoxanide are attributed to modulation of mitochondrial function and consequential effects on cell signaling pathways. About NT-300
NT-300 (nitazoxanide extended-release tablets) is an investigational broad-spectrum antiviral drug undergoing Phase 3 clinical development for treating and preventing acute respiratory illnesses caused by a broad range of seasonal, emerging or drug-resistant respiratory viruses, including influenza viruses, rhinoviruses, enteroviruses, coronaviruses, parainfluenza viruses, respiratory syncytial viruses (RSV), human metapneumovirus or bocavirus. The NT-300 tablets, administered orally, are designed to deliver antiviral concentrations of drug to the respiratory tract throughout twice-daily dosing. The 600 mg dose was selected based upon a dose-range-finding clinical trial conducted in outpatients with influenza.6?To date, clinical trials of NT-300 for treatment of viral respiratory illnesses have included more than 5,000 patients. The NT-300 clinical development program has been designed to provide robust evidence of effectiveness to support use of NT-300 and to ensure maximum benefit to the very large number of patients that experience these illnesses. About Romark
Romark is a vertically-integrated, research-based 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 it conducts research and development and commercializes its products globally. Romark is a leader in developing new drugs for treating a broad range of seasonal, emerging and drug-resistant viral respiratory illnesses. It is also developing a new product aimed at inducing functional cure of chronic hepatitis B. Products discovered, developed and commercialized by Romark have been used to positively impact the lives of more than 400 million people worldwide. References
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- Hong SK, Kim HG, Chong CS, Choi IS, Lee JB, Park SY. Nitazoxanide suppresses IL-6 production in LPS-stimulated mouse macrophages and TG-injected mice.?Int Immunopharmacol?2012; 13:23-7.
- Haffizula J, Hartman A, Hoppers M, et al. A randomized, double-blind, placebo controlled clinical trial of nitazoxanide in adults and adolescents with acute uncomplicated in?uenza.?Lancet Infect Dis?2014; 14:609-618.
Jon Siegal
Weber Shandwick
jsiegal@webershandwick.com
(781) 962-6599 SOURCE Romark
