DIGESTIBILITY AND SURVIVAL OF IMMUNOGLOBULIN PREPARATIONS THROUGH THE GASTROINTESTINAL TRACT IN HUMANS FOR DISTRIBUTION

Entera Health, Inc. announced today the publication of a new review article published in the Nutrition Journal titled "Survival and digestibility of orally-administered immunoglobulin preparations containing IgG through the gastrointestinal tract in humans". The authors include Victoria S. Jaison, PhD (Cary, NC USA) and Bruce P. Burnett, PhD (Cary, NC USA).

The results of this review of the scientific literature show that the majority of human studies conducted in infants, children and adults provide evidence that immunoglobulins, found in orally-administered protein preparations obtained from human and bovina serum as well as bovine colostrum and milk, can survive gastric exposure and resist proteolytic digestion during transit through the stomach and intestinal tract. These immunoglobulins contain structural elements which may offer an explanation for the increased stability against digestion compared to other nutritional proteins.

The studies summarized in this review illustrate that immunoglobulins, particularly IgG, survive digestion and reach the appropriate areas of the intestinal tract to bind bacterial antigens and impart other actions that help maintain immune balance, manage gut barrier function, and improve nutrient utilization.

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About Oral Immunoglobulin Preparations

Protein preparations derived from bovine serum or colostrum and enriched for immunoglobulins have been used for decades in animal feed to improve growth, increase feed utilization, and reduce morbidity and mortality associated with various intestinal disorders that are frequently associated with early weaning. Oral administration of immunoglobulin preparations from bovine serum and colostrum have also been tested and proven to be safe and effective in human clinical trials for a variety of enteric microbial infections and other conditions including irritable bowel syndrome with diarrhea (IBS-D), inflammatory bowel disease (IBD), and HIV associated enteropathy.

About EnteraGam™

EnteraGam™ (serum-derived bovine immunoglobulin/protein isolate, SBI) is a prescription medical food product indicated for the clinical dietary management of enteropathy [e.g., in diarrhea-predominant irritable bowel syndrome (IBS-D) and HIV-associated enteropathy]. EnteraGam™ is required to be used under physician supervision as part of ongoing medical care for a specific condition or disease. EnteraGam™ is also indicated for the clinical dietary management of enteropathy in patients who, because of therapeutic or chronic medical needs, have limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients. For full prescribing information, please visit our product website at www.enteragam.com.

Important Safety Information

EnteraGam™ is a specially formulated protein source for the management of intestinal disorders. The product has been extremely well tolerated for up to a year in HIV patients and up to 8 months in infants. The major side effects in clinical trials (2-5%) have included mild nausea, constipation, stomach cramps, headache, and increased urination. EnteraGam™ is contraindicated for patients with a hypersensitivity (allergy) to beef, or any components in EnteraGam™. Therefore, patients who have an allergy to beef or any component of EnteraGam™ should not take this product. EnteraGam™ has not been studied in pregnant and nursing mothers. The choice to administer EnteraGam™ in pregnant or nursing mothers is at the clinical discretion of the physician. Medical foods like EnteraGam™ are required by FDA regulations to be dosed and monitored by physicians as part of ongoing care for patients with chronic conditions or diseases.

About Entera Health, Inc

Entera Health, Inc. is focused on improving worldwide health through the development of clinically safe biotherapeutics to address unmet needs. Our passion is to help people thrive through healthier living. Our motivation for conducting basic research, clinical studies, and appropriately educating patients and healthcare providers is driven to meet this goal. Visit us at www.enterahealth.com.

For questions, please contact:
Tom Heck, Chief Operating Officer
515-963-7560
Tom.heck@enterahealth.com

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