Romark announces results from NT-300 Phase 2B-3 trial on influenza

Romark Laboratories announced that results of a large Phase 2B-3 US clinical trial of its new flu drug, NT-300 (nitazoxanide), will be presented as an oral late-breaking communication at the 49th Annual Meeting of the Infectious Diseases Society of America (IDSA) being held in Boston, October 20-23, 2011.  

The clinical trial enrolled 624 patients at 74 outpatient primary care centers throughout the United States during the 2010-2011 flu season. The trial achieved its primary endpoint showing that influenza-infected patients treated with NT-300 administered 600 mg twice daily for five days experienced statistically significant reduction in time from beginning treatment to alleviation of flu symptoms compared to influenza-infected patients receiving the placebo.

Approximately half of the influenza-infected patients enrolled in the US clinical trial were infected with influenza A subtype H1N1 ("swine flu") with approximately 30% being infected with influenza B and 20% with influenza A subtype H3N2.

"These data are encouraging," said Jean-Francois Rossignol, M.D., Ph.D., Chairman and Chief Science Officer of Romark.  "We currently have only two drugs to treat influenza, both neuraminidase inhibitors, and resistance is a major concern. There is an urgent need for a new drug with a different mechanism of action for treating influenza."

Data from two other Phase 2 clinical trials, including one clinical trial in children down to 12 months of age, and laboratory studies of the drug's activity against influenza viruses will also be presented at the IDSA meeting.  In total, four different communications will be presented.  The meeting is attended by infectious disease physicians, scientists and public health personnel from the United States and around the world.  

Romark plans to initiate another Phase 3 clinical trial of NT-300 during the coming flu season and to seek FDA approval to market NT-300 for treatment of acute uncomplicated influenza.  The company also plans to develop NT-300 for prevention of influenza and for treatment of influenza in special populations (e.g., pediatric patients under 12 years of age, geriatric patients and patients with severe illness or underlying medical conditions).

NT-300, an investigational new drug in the United States, is an oral controlled release tablet that contains 300 mg of nitazoxanide (NTZ) as active ingredient. NTZ is the first of a new class of small molecule immunomodulatory drugs called thiazolides. Romark is using this new class of drugs as a technology platform for developing new drugs for treating a broad range of viral diseases and cancers.  NT-300 is undergoing clinical development for treatment of influenza.

There are presently only two classes of drugs approved by the FDA for treating flu: the neuraminidase inhibitors, oral Tamiflu® (oseltamivir) and inhaled Relenza® (zanamivir), and the older M2 inhibitors, amantadine and rimantadine. The M2 inhibitors are no longer effective against circulating influenza strains. Resistance to the neuraminidase inhibitors has been observed, and during the 2008-2009 flu season, approximately 99% of circulating influenza A H1N1 strains were resistant to oseltamivir (Tamiflu®), the only oral drug for treating influenza. There has not been a new class of drugs approved for treating influenza since Tamiflu® and Relenza® were approved by FDA in 1999.  

Data from laboratory studies of NTZ to be presented at the IDSA meeting have shown that NTZ is active against a broad range of influenza viruses including oseltamivir- and amantadine-resistant strains.  Laboratory studies designed to create or select for influenza strains resistant to NTZ could not identify viruses resistance to NTZ in cell cultures.  Other studies showed that NTZ was also active in cell culture against other respiratory viruses that may cause flu-like symptoms including coronavirus and parainfluenza virus.  Finally, laboratory studies to be communicated at the IDSA meeting have shown strong synergistic activity of combinations of NTZ and oseltamivir (the active ingredient in Tamiflu®) against influenza viruses in cell cultures.

The four communications to be presented at the IDSA meeting are:

1.  Randomized, Double-Blind, Pilot Study of Nitazoxanide (NTZ) Versus Placebo (PCB) for the Treatment of Symptoms Associated with Viral Respiratory Infection (VRI) in Adults and Adolescents.  Nicolas Lopez-Chegne, Luis-Martin Julcamoro, Maria Carrion, Jean-Francois Rossignol, Matthew Bardin. Presentation Number 142, Session 37, Oral Abstract Session: Clinical Virology and Treatment. Friday, October 21, 2011, 9:45 AM.

2.  Nitazoxanide, a Novel Potential Anti-Influenza Drug, Acting in Synergism with Neuraminidase Inhibitors. Giuseppe Belardo, Simone La Frazia, Orlando Cenciarelli, Stefania Carta, Jean-Francois Rossignol, M. Gabriella Santoro. Presentation Number 1181, Session 149, Poster Abstract Session: New Approaches to Anti-viral Therapy. Saturday, October 22, 2011, 1:45 PM.

3.  Randomized, Double-Blind, Pilot Study of Nitazoxanide (NTZ) Versus Placebo (PCB) for the Treatment of Symptoms Associated with Viral Respiratory Infection (VRI) in Children.  Nicolas Lopez-Chegne, Luis-Martin Julcamoro, Maria Carrion, Jean-Francois Rossignol, Matthew Bardin. Presentation Number 1341, Session 174, Oral Abstract Session: Respiratory Infections in Children. Saturday, October 22, 2011, 2:00 PM.

4.  A Randomized, Double-Blind, Placebo (PCB) Controlled Study of Nitazoxanide (NTZ) in Adults and Adolescents with Acute Uncomplicated Influenza.  Jean-Francois Rossignol, Sreedhar Samudrala, Melanie Hoppers, Jason Haffizulla, Harvey Resnick, Aaron Hartman, Stefan Comhaire, Maria Carríon, Matthew Bardin. Presentation Number LB-35, Session 182a: Late Breaker Oral Abstracts - Clinical Virology and Treatment. Saturday, October 22, 2011, 6:30 PM.