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Recent Developments
Monday, ELGO released news that it is in process of acquiring or licensing specific probiotic strains and developing these to meet the exacting standards necessary for FDA approval as prescription biologics for specific gastrointestinal (GI) indications.
Many GI disorders are poorly addressed by current therapies, including pouchitis, irritable bowel syndrome (IBS), Crohn's disease, ulcerative colitis and Clostridium difficile infections.
Today, most probiotic bacteria are sold over-the-counter as dietary supplements or in food products such as yogurt, with ambiguous benefits. Instead, ELGO plans to commercialize its probiotic strains as biologics, each meeting FDA standards for clinical efficacy and approval for a specific indication.
"ELGO believes that this will establish a unique and strong competitive position in the market." -Bob Hoerr, Co-Founder and President.
Enterologics will bring specific probiotic strains to market as FDA-approved biologic drugs, using:
• A rigorous testing program to prove clinical efficacy for inadequately treated GI disease • A new preservation technology that to maintain viable bacterial cells and long shelf-life
Fresh interest in probiotics was prompted by reports in the popular press linking yogurt consumption with longevity. There were also grave concerns in the medical literature about a striking rise in antibiotic resistant bacteria as well as the destructive effects of antibiotics on the healthy gut flora. More recently, the presence of damaging bacteria residing in the gut (H. pylori) has been shown to be a primary cause of peptic ulcers, a disease that had previously been thought to be caused by too much acid or stress.
Some scientists believe that infection with a yet-to-be microorganism may be an underlying factor leading to inflammatory bowel disease. These trends stimulated more research on strains of bacteria isolated from healthy gut flora as well as from the family of strains used to ferment foods and dairy products, resulting in the identification of a number of Lactobacillus, bifidobacteria, E. coli and yeast strains that had beneficial effects on human and animal health.
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