EnteraGam™ (Serum-derived bovine immunoglobulin/protein isolate, SBI) Available Soon
CARY, NC (Business Wire May 22, 2013) – Entera Health, Inc. announces today three presentations were given at Digestive Disease Week DDW® 2013, which was held in Orlando, FL, Saturday, May 18 – Tuesday, May 21.
Dr. Eric Weaver presented initial clinical data on the use of the prescription medical food, EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate; SBI), for diarrhea-predominant irritable bowel syndrome (IBS-D) to the Rome Foundation. Dr. Weaver discussed some of its possible multifaceted mechanisms of action as shown in previous nonclinical and clinical studies.
Dr. Bruce Burnett provided an educational presentation to the Rome Foundation regarding the FDA-regulated category of medical foods. As defined in section 5(b) of the Orphan Drug Act, “a medical food is formulated to be consumed or administered orally or enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.”
Dr. Gerald L. Klein presented a poster at DDW showing efficacy of the prescription medical food, EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate; SBI), for diarrhea-predominant irritable bowel syndrome (IBS-D). In his presentation, Dr. Klein discussed data which showed that the group that was given EnteraGam™ 10 g/day had statistically significant improvement in the number of days with any symptom including loose stools, abdominal pain, bloating, flatulence, and urgency from 2 week baseline through the end of treatment. The placebo group did not show this improvement. Dr. Klein concluded that EnteraGam™ may provide distinct nutrition for a multifaceted therapeutic approach aimed at restoring mucosal membrane integrity and inhibiting decreasing intestinal inflammation in patients with IBS-D.
The Rome Foundation is an independent not for profit 501(c) 3 organization that provides support for activities designed to create scientific data and educational information to assist in the diagnosis and treatment of functional gastrointestinal disorders (FGIDs). Its mission is to improve the lives of people with functional GI disorders. For more information on The Rome Foundation, please visit http://www.romecriteria.org
EnteraGam™ (SBI) is a prescription medical food product indicated for the clinical dietary management of enteropathy (intestinal disorders) under medical supervision (for more information, please email email@example.com). EnteraGam™ will be commercially available in the United States in July 2013.
About Entera Health, Inc.
Entera Health, Inc. is a biotherapeutic company focused on improving worldwide health through development of clinically safe biotherapeutics to address unmet needs. Entera conducts continuing research utilizing value added proteins and protein co-products to find additional compounds that positively impact human health. Products are being developed for oncology, gastroenterology, and immune disorders. Visit our site: