STUDY SHOWS ENTERAGAM® (SERUM-DERIVED BOVINE IMMUNOGLOBULIN/PROTEIN ISOLATE, SBI) CONTRIBUTES TO RESTORATION OF MUCOSAL IMMUNITY

Entera Health, Inc. today announced results from a multicenter study evaluating the impact of SBI, the main ingredient found in EnteraGam®, on markers of peripheral and mucosal immunity, GI symptoms, and stability of gut microbial communities in HIV-infected patients on long-term suppressive highly active antiretroviral therapy (HAART) with documented HIV enteropathy. Results from the trial were presented at the American Association of Immunologists annual conference in New Orleans, LA.

Enrolled patients were randomized in a blinded fashion to receive SBI at a dose of 2.5 vs 5.0 grams BID or placebo during a 4-week, placebo-controlled phase, followed by a placebo-free extension phase for 20 weeks. A subset of 8 patients underwent upper endoscopy for distal duodenum biopsies at baseline and week 24.

Evaluation of all patients in the study showed no change in circulating levels of CD4+ T cells from baseline to 24 weeks of SBI therapy. However, a subset of patients with the fewest CD4+ cells at baseline (≤ 418 cells/microliter; N=24) had increased CD4+ counts at week 4 vs. placebo (p=0.02); this effect was maintained through week 24. Evidence for significant increase in duodenal CD4+ cells [p=0.02] was also observed in the subset of patients received SBI therapy for 24 weeks and who underwent upper endoscopy. Positive changes were also observed in markers of intestinal health [decreased duodenal crypt cells expressing Ki67 (p=0.08); decreased Paneth cells (p=0.008)].Collectively, the results suggest that SBI therapy provides for distinctive nutritional requirements in support of mucosal immunity in patients with suboptimal CD4+ T-cell counts despite prolonged suppressive HAART.

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 (1). Diarrhea and related GI complaints remain in nearly 30% of patients in the post-HAART era (2). 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 (3).

About EnteraGam®

EnteraGam® 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® 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 http://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 http://www.enterahealth.com/.

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

REFERENCES:

1. 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.

2. 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.

3. 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

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