Romark Laboratories Completes Enrollment Of Global Phase 3 Clinical Trial Of Nt-300 For Treatment Of Influenza
1941 Patients Enrolled in the United States, Canada, Belgium, Australia and New Zealand
Largest Single Clinical Trial Ever Conducted for a New Drug for Acute Uncomplicated Influenza
Data to be Communicated Later in 2015
TAMPA, Fla. – June 3, 2015 – Romark Laboratories announced today that it has completed enrollment in the Influence Study, its Phase 3 clinical trial of NT-300 (nitazoxanide) for treatment of acute uncomplicated influenza. The study enrolled 1,941 patients during five influenza seasons in five countries: the United States, Canada, Belgium, Australia and New Zealand.
The Influence Study is the largest single clinical trial ever conducted for a new drug in development for acute uncomplicated influenza. It is also the first registration-style clinical trial to study a combination of drugs for treatment of acute uncomplicated flu.
"We are excited to have reached this milestone," said Jean-François Rossignol, M.D., Ph.D., Chairman and Chief Medical and Scientific Officer of Romark. "There is a pressing need for a new drug with a new mechanism of action for treating flu. We are pleased to be advancing our program and look forward to analyzing the data and submitting a New Drug Application for NT-300."
Completion of enrollment of the Influence Study was communicated at the 4th ISIRV Antiviral Group Conference held in Austin, Texas.
Patients enrolled in the study were randomly assigned to receive treatment with either NT-300, placebo (sugar pill), oseltamivir (Tamiflu®) or NT-300 plus oseltamivir. The primary objectives of the study are to demonstrate that (i) NT-300 reduces the duration of symptoms compared to treatment with placebo and (ii) NT-300 co-administered with oseltamivir reduces the duration of symptoms compared to NT-300 alone and to oseltamivir alone.
After completing this clinical trial, Romark plans to submit a New Drug Application seeking FDA approval to market NT-300 administered alone or in combination with oseltamivir as a treatment of acute uncomplicated influenza.
Currently, there are only two classes of drugs approved in the United States for treating influenza, and only the neuraminidase inhibitors, oral Tamiflu® (oseltamivir), inhaled Relenza® (zanamivir) and intravenous Rapivab® (peramivir), are recommended for use. There has not been a new class of drug approved in the United States for treating influenza since Tamiflu® and Relenza® were approved in 1999. New drugs with different mechanisms of action could be important in overcoming drug resistance and providing better treatment for patients with influenza.
The Phase 3 clinical trial of NT-300, other licensure enabling nonclinical and clinical studies, and the preparation of a New Drug Application for NT-300 are being funded by the U.S. Department of Health and Human Services (HHS)/Office of the Assistant Secretary of Preparedness and Response (ASPR)/Biomedical Advanced Research and Development Authority (BARDA) under contract HHSO100201300004C.
Influenza (flu) is a contagious respiratory illness caused by influenza viruses. According to the United States Centers for Disease Control and Prevention (CDC), seasonal flu affects, on average, 5% to 20% of the United States population per year leading to approximately 200,000 hospitalizations and 3,000 to 49,000 deaths. Pandemic influenza refers to a global outbreak of flu caused by a new emerging influenza virus that has the ability to infect and be passed among humans and to which there is little or no immunity. The threat of pandemic influenza is a major concern because of its potential effect on human life as well as the economy, national security and the basic functioning of society.
NT-300, a controlled release tablet for oral administration containing 300 mg of nitazoxanide (NTZ) as active ingredient, is being developed by Romark Laboratories for treatment of influenza. NTZ inhibits replication of a broad range of influenza viruses in cell culture assays, including oseltamivir- and amantadine-resistant strains, as well as other respiratory viruses that may cause flu-like symptoms in humans including the paramyxoviridae and the coronaviridae. In cell culture assays, NTZ and oseltamivir act synergistically in inhibiting replication of influenza viruses. In a Phase 2b/3 clinical trial conducted in the United States during the 2010-2011 influenza season, NT-300 administered 600 mg orally twice daily for 5 days reduced the duration of symptoms of acute uncomplicated influenza compared to a placebo and reduced viral titers in nasal swabs collected during treatment.
About Romark Laboratories
Romark Laboratories, L.C. is a vertically integrated biopharmaceutical company committed to the discovery and development of innovative small molecule drugs for treating infectious diseases and cancers. The Company markets Alinia® (nitazoxanide) tablets, 500 mg in the United States through a specialty sales force focused on gastroenterologists and primary care physicians.
Romark is developing a class of small molecule drugs called thiazolides. The Company’s product, NT-300 (nitazoxanide), is presently undergoing Phase 3 clinical development on a global basis for treatment of acute uncomplicated influenza. The NT-300 development program is being conducted under contract HHSO100201300004C with the U.S. Department of Health and Human Services. Other new drugs from the Company’s platform technology are proposed for treatment of viral diseases and cancers.