The randomized, double-blind trial will compare the efficacy and safety of Alinia to that of a placebo. Alinia will be administered orally as a single 500 mg tablet two times per day. The study will be conducted in multiple centers in the United States.
“We believe nitazoxanide (Alinia) presents a unique and innovative approach to treating Crohn’s disease,” said Jean-Francois Rossignol, chief science officer of Romark Laboratories. “In vitro studies have shown that the drug is active against a broad spectrum of anaerobic bacteria and that it inhibits the secretion of pro-inflammatory cytokines including TNF-alpha. Both of these mechanisms are believed to be important in managing Crohn’s disease.”
Crohn’s disease is a chronic disease marked by an abnormal immune response that results in inflammation of the gastrointestinal tract.
Researchers believe that the immune system mistakes microbes, such as bacteria that is normally found in the intestines, for foreign or invading substances, and launches an attack. In the process, the body sends white blood cells into the lining of the intestines, where they produce chronic inflammation. These cells then generate harmful products that ultimately lead to bowel injury.