Romark Laboratories, L.C. Romark Laboratories, L.C. Romark Laboratories, L.C. Romark Laboratories, L.C. Romark Laboratories, L.C.

News & Events

News

Romark Announces Publication Of Data From Phase 2B-3 Clinical Trial Of Nt-300 In The Treatment Of Influenza

Results of US Clinical Trial Published in The Lancet Infectious Diseases

Trial Successfully Achieves Primary Efficacy Endpoint, Reducing Duration of Symptoms of Acute Uncomplicated Influenza

TAMPA, Fla. – May 20, 2014 – Romark Laboratories announced today that results of a Phase 2b-3 clinical trial of NT-300 have been published in The Lancet Infectious Diseases.

The clinical trial enrolled 624 patients at 74 outpatient primary care centers throughout the United States during the 2010-2011 flu season. Top-line results were previously communicated as a late-breaking communication at the 49th Annual Meeting of the Infectious Diseases Society of America in October 2011. Treatment with NT-300 administered 600 mg twice daily for five days was associated with a significant reduction of duration of symptoms compared to patients receiving the placebo.

"The data published in The Lancet Infectious Diseases is encouraging," said Jean-François 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."

The complete reference for the publication is: Haffizulla J, Hartman A, Hoppers M, Resnick H, Samudrala S, Ginocchio C, Bardin M, Rossignol JF. A randomized, double-blind, placebo controlled clinical trial of nitazoxanide in adults and adolescents with acute uncomplicated influenza. The Lancet Infectious Diseases, 2014;14:609-618.

Romark is presently conducting a Phase 3 clinical trial to evaluate the efficacy and safety of NT-300 or NT-300 plus oseltamivir compared to a placebo or to oseltamivir alone in treating outpatients 13 to 65 years of age with acute uncomplicated influenza. Upon successful completion of the Phase 3 clinical trial, the company plans to submit a New Drug Application for NT-300 administered alone and in combination with oseltamivir for treatment of influenza.

The Phase 3 clinical trial along with Phase 1 clinical trials and other development work required to enable licensure of NT-300 and the NDA submission are being conducted under contract HHSO100201300004C with the U.S. Department of Health and Human Services.

About the Phase 2b-3 Clinical Trial

The clinical trial was conducted in 74 outpatient primary care centers throughout the United States during the 2010-2011 flu season. 624 patients, 12 to 65 years of age, with influenza symptoms were enrolled in the study within 48 hours of symptom onset and received treatment with 300 mg nitazoxanide (NTZ), 600 mg NTZ or placebo twice daily for 5 days. Patients who received an influenza vaccine after August 1, 2010 and patients at risk of complications of influenza based upon CDC or IDSA criteria were excluded from participation in the trial. The study was designed according to FDA Guidance and consistent with prior clinical trials of Tamiflu® and Relenza®. The primary efficacy endpoint of the study was time from first dose to alleviation of symptoms (all symptoms absent or mild and remain so for 24 hours).

Two hundred and fifty-seven (257) of the 624 patients enrolled in the study (41%) had laboratory confirmed influenza infection by RT-PCR or viral culture at baseline. 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. 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 (P=0.008). Median time to alleviation of symptoms was 95.5 hours for the 600 mg dose group compared to 109.1 hours for the 300 mg dose group and 116.7 hours for patients receiving the placebo. Time to resolution of symptoms for the low dose group were less than for the placebo, but the difference was not statistically significant (P=0.521). Patients in the 600 mg NTZ treatment group also experienced statistically significant reductions in quantitative viral shedding compared to patients receiving the placebo (P=0.0006). Adverse events were similar for the three treatment groups except for a higher rate of mild diarrhea in the 600 mg treatment group (8.1%) compared to the placebo treatment group (3.3%).

About NT-300

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.