ENTERAGAM® (SERUM-DERIVED BOVINE IMMUNOGLOBULIN/PROTEIN ISOLATE, SBI) RESULTS PRESENTED ON REDUCTION OF IMMUNE ACTIVATION IN PATIENTS WITH HIV-ASSOCIATED ENTEROPATHY

Study Results Presented at the Conference on Retroviruses and Opportunistic Infections (CROI) Demonstrate Benefits of Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI), the Main Ingredient in EnteraGam®, in HIV Patients with HIV-Associated Immune Dysfunction.

Entera Health, Inc. today announced additional results from a multi-center study evaluating the impact of SBI in patients with HIV-associated enteropathy and on long-term suppressive antiretroviral therapy (ART). Previous analysis showed that SBI led to increases in peripheral CD4+ T-cells after 4 and 24 weeks (p≤0.02) among patients in the lowest quartile for baseline (BL) CD4+ T-cells (≤418 cells/µL) (1). Results reported on the follow up analysis showed that the same subgroup of patients with low levels of circulating CD4+ T-cells showed significant reductions (p≤0.001) in circulating IL-6 levels, a marker of immune activation. Significant correlations were also reported between several other serum and mucosal biomarkers of bacterial antigen absorption, immune dysfunction, or enterocyte integrity.

“Collectively, the results from this study suggest that SBI therapy may be a novel strategy to manage gut barrier function, enterocyte integrity, and mucosal immunity and help support systemic immune reconstitution among patients who have not achieved normal CD4+ T-cell counts despite prolonged suppressive HAART”, said Dr. David Asmuth, Professor of Medicine at the University of California at Davis who presented the findings at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI 2016) in Boston, MA.

The study enrolled HIV-infected patients who were on long-term highly active ART with documented HIV-associated enteropathy. Study subjects received SBI at a dose of 2.5 vs 5.0 grams or placebo twice daily during a 4-week, placebo-controlled phase which was followed by a placebo-free extension phase where subjects took SBI at 2.5 vs 5.0 grams for an additional 20 weeks. A duodenal biopsy substudy (n=8) was also performed to confirm findings of an earlier pilot study which demonstrated a significant increase in lamina propria CD4+ T-cell density (2). Study parameters included GI symptoms, biomarkers of peripheral and mucosal immunity, gut microbiome and evaluation of intestinal function.

About HIV-Associated Enteropathy

Early HIV infection leads to acute CD4+ T-cell depletion, particularly in the gut, which is associated with bacterial translocation and systemic immune activation. CD4+ T-cell recovery within the gut associated lymphoid tissue (GALT) is impaired even after treatment with highly active antiretroviral therapy (HAART). HIV enteropathy is a syndrome of gastrointestinal (GI) complaints that persist without clear reason despite exhaustive evaluation and is likely due to imbalances of intestinal bacteria or gut permeability (3, 4). Diarrhea and related GI complaints remain in nearly 30% of patients in the post-HAART era (5). Results from a previous study showed positive effects of SBI therapy on repopulation of lymphocyte populations in gut-associated lymphoid tissue (GALT), improved duodenal function, and possible intestinal repair after SBI therapy (2).

About EnteraGam®

EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) is a prescription medical food product intended to provide for distinctive nutritional requirements that are unique for the clinical dietary management of specific intestinal disorders [e.g., in irritable bowel syndrome with diarrhea (IBS-D), inflammatory bowel disease (IBD), and HIV-associated enteropathy]. EnteraGam®, as a medical food, must be used under physician supervision.

Important Safety Information

EnteraGam® contains beef protein; therefore, patients who have an allergy to beef or any component of EnteraGam® should not take this product. The most commonly reported adverse events in clinical studies (incidence of 2%-5%) include mild nausea, constipation, stomach cramps, headache, and increased urination. EnteraGam® has not been studied in pregnant or nursing women, so the choice to administer EnteraGam® for patients who are pregnant or nursing is at the clinical discretion of the prescribing physician. EnteraGam® does not contain any milk products such as lactose, casein, or whey. It is gluten-free, dye-free, and soy-free. EnteraGam® contains 5 g of SBI and other ingredients such as dextrose (5 g) and trace amounts of sunflower lecithin. For full prescribing information, visit the product website at http://enteragam.com/.

About Entera Health, Inc.

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

For questions, please contact:
Aage Lauridsen, Chief Executive Officer
515-963-7599
Aage.Lauridsen@enterahealth.com

REFERENCES:

1. Asmuth D.M., M. Samsouk, et al. Serum-Derived Bovine Immunoglobulin Protein Isolate Increases Peripheral and Mucosal CD4+ T-cell counts in Patients with HIV Enteropathy. AS 2015; July 19-22, 2015 Vancouver, BC

2. Asmuth DM, Ma Z-M, Albanese A, et al. Oral serum-derived bovine immunoglobulin improves duodenal immune reconstitution and absorption function in patients with HIV enteropathy. AIDS 2013; 27:2207-2217.

3. MacArthur RD and Dupont HL. Etiology and pharmacologic management of noninfectious diarrhea in HIV-infected individuals in the HAART era. Clin Infect Dis. 2012; 55:860-867.

4. Dillon SM, Lee EJ, Kotter CV, et al. An altered intestinal mucosal microbiome in HIV-1 infection is associated with mucosal and systemic immune activation and endotoxemia. Mucosal Immunology 2014; 7: 983-994.

5. Siddiqui U, Bini EJ, Chandarana K, et al. Prevalence and impact of diarrhea on health-related quality of life in HIV-infected patients in the era of highly active antiretroviral therapy. J Clin Gastroenterol. 2007; 41:484-490.

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