The clinical trial is being conducted in approximately 25 sites across the US and is expected to enroll 440 adult patients with acute uncomplicated influenza. It is also expected to evaluate the effect of treatment on other parameters such as the severity of symptoms, complications of influenza and time to return to normal activities.
The company said that the clinical trial follows a published report in the October 23, 2009 issue of the Journal of Biological Chemistry titled, ‘Thiazolides, A New Class of Anti-influenza Molecules Targeting Viral Hemagglutinin at the Post-Translational Level.’
In the article, scientists reported that nitazoxanide (the active ingredient of Alinia) and other drugs from the class, thiazolides, inhibit the replication of influenza A viruses, including H1N1 and H5N9 (a low pathogenicity avian strain) and influenza B virus, in laboratory studies by a new mechanism.
The company said that it is also developing nitazoxanide for treating a broad range of patients with chronic hepatitis C. Phase 2 clinical trials of nitazoxanide, in combination with peginterferon or peginterferon plus ribavirin, have either been completed or are ongoing in treatment-naive and treatment-experienced patients infected with HCV genotypes 1 and 4 and in patients co-infected with HCV and HIV.
The company expects to begin phase 3 clinical trials of nitazoxanide, in combination with peginterferon with or without ribavirin, during 2010.
Jean-Francois Rossignol, chief science officer of Romark, said: “Following completion of the research published last October, we filed an Investigational New Drug application with FDA in November and have been working quickly to initiate this clinical trial so that it can be conducted in the US during the current flu season. We need to complete this clinical trial, but if our results are favorable, we will move aggressively to complete a full development program. Alinia is already marketed in the US for treating other infectious diseases.
“Our experience with the product coupled with heightened awareness of the threat of pandemic influenza and the need for a new class of drugs could provide an accelerated path to obtaining regulatory approvals and making the product available for the prevention and treatment of influenza.”