EVALUATION OF SERUM-DERIVED BOVINE IMMUNOGLOBULIN/PROTEIN ISOLATE IN AN INTESTINAL CO-CULTURE MODEL

Entera Health, Inc. announced today a new scientific publication appearing in the journal PLOS One titled "Bovine Immunoglobulin/Protein Isolate Binds Pro-Inflammatory Bacterial Compounds and Prevents Immune Activation in an Intestinal Co-Culture Model". Authors include: Christopher J. Detzel (Ankeny, IA), Alan Horgan (Ankeny, IA), Abigail L. Henderson (Ankeny, IA), Bryon W. Petschow (Cary, NC), Christopher D. Warner (Ankeny, IA), Kenneth J. Maas (Ankeny, IA), and Eric M. Weaver (Ankeny, IA).

The studies described in this report used a cell culture model of the intestinal epithelium to investigate the mechanisms by which oral immunoglobulin preparations may impart benefits to patients with intestinal disorders. The secretory IgA immunoglobulin is known to protect the intestine, but little is known about the potential effects of IgG and IgM. Using a modified ELISA method, this study showed that several immunoglobulin isotypes (IgG, IgA, and IgM) bind bacterial cell wall antigens that are commonly found in the intestinal lumen (LPS, Lipid A). More importantly, this binding of bacterial antigens also inhibited the production of inflammatory cytokines from THP-1 monocytes, a type of immune cell; such an effect is known as ‘immune exclusion’. A second mechanism was demonstrated in other experiments using the co-culture model when immunoglobulins in SBI bound to another model antigen (known as Pam3CSK4) which created a larger complex that was no longer able to pass through a damaged epithelial barrier. This mechanism is referred to as ‘steric exclusion’. These studies demonstrate a role for IgG and IgM in SBI in acting through immune and steric exclusion mechanisms in the intestinal lumen, which expands our understanding of how SBI can effectively manage intestinal homeostasis.

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VIEW A BRIEF VIDEO ANIMATION OF THE POTENTIAL MECHANISM OF ACTION OF SBI

About Irritable Bowel Syndrome (IBS)

Irritable bowel syndrome (IBS) is a complex and commonly diagnosed gastrointestinal disorder, characterized by recurrent abdominal pain or discomfort associated with altered bowel habits, that negatively affects patients’ daily activities and quality of life. Population-based studies indicate that the worldwide prevalence of IBS is approximately 9% to 22%. Symptoms may include abnormal stool form or frequency, defecation straining, bloating, urgency, feelings of incomplete bowel movement, and passing mucus. It is further categorized based upon stool consistency leading to a diagnosis of IBS with either constipation (IBS-C), diarrhea (IBS-D), mixed with alternating constipation and diarrhea (IBS-M) or undefined (IBS-U) which may have symptoms of bloating and distention. Unfortunately, most therapies that are currently used to manage patients with IBS are aimed at lessening symptoms rather than the underlying cause of the disorder, which has led to an increased interest in multi-modal therapeutic approaches aimed at restoring intestinal health and nutritional status for these patients.

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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