Romark Initiates New Phase 3 Clinical Trial Of NT-300 For The Treatment Of COVID-19

TAMPA, Fla., Aug. 11, 2020 /PRNewswire/ -- Romark, a research-based pharmaceutical company focused on the discovery, development and delivery of innovative new medicines, primarily in the field of infectious diseases, announced today the initiation of a Phase 3 clinical trial of its investigational new drug candidate NT-300 (nitazoxanide extended-release tablets) as a treatment for mild or moderate COVID-19.

"As the COVID-19 pandemic continues to take a toll on our collective health, economy and well-being, we are pleased to broaden our NT-300 COVID-19 clinical program through the initiation of a third trial evaluating NT-300 as a treatment in addition to our two ongoing prophylactic trials," said Jean-François Rossignol, M.D., Ph.D., Chief Medical and Scientific Officer of Romark. "Along with vaccines and treatments for severe illness, oral treatments that can be given outside of a hospital setting to prevent infection or used as soon as symptoms appear to reduce the duration of illness and prevent hospitalizations are desperately needed. Given the broad spectrum antiviral properties of NT-300, this research is an important step in our understanding of its potential impact on COVID-19 in its early stages."

The multicenter, randomized, double-blind trial will study up to 800 people twelve years and older with fever and respiratory symptoms consistent with COVID-19. These participants will be given either NT-300 or placebo twice daily for five days. Efficacy analyses will examine those participants who have laboratory-confirmed SARS-CoV-2 infection. The primary endpoint is a reduction in the time to sustained response (a measure of recovery time) compared with placebo, and the secondary endpoint is a reduction in the rate of progression to severe COVID-19 illness compared with placebo. For more information on the trial, please visit ClinicalTrials.gov.

Earlier this year, Romark initiated two Phase 3 clinical trials for the prevention of COVID-19 and other viral respiratory illnesses in high-risk populations, including elderly residents of long-term care facilities and healthcare workers. Romark anticipates sharing results from these studies later this year.

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

Clinical investigators or sites interested in participating in one of Romark's COVID-19 clinical trials should email [email protected] or call 877-925-4642.

About Nitazoxanide
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, other 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.

Media Contact
Jon Siegal
Weber Shandwick
[email protected]
(781) 962-6599

References

1. Wang M, Cao R, Zhang L, et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro. Cell Res 2020; 0:1-3.
2. Rossignol JF. Nitazoxanide: A first-in-class broad-spectrum antiviral agent. Antivir Res 2014; 110:94-103.
3. Cao J, Forrest JC, Zhang X. A screen of NIH Clinical Collection small molecule library identifies potential anti-coronavirus drugs. Antivir Res 2015; 114:1-10.
4. Rossignol JF. Nitazoxanide, a new drug candidate for the treatment of Middle East respiratory syndrome coronavirus. J Infect Public Health 2016; 9:227-230.
5. 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.
6. 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 influenza. Lancet Infect Dis 2014; 14:609-618.

RM-UA-004-01V1 R08.20

SOURCE Romark