NEW CLINICAL DATA ABOUT ENTERAGAM® (SERUM-DERIVED BOVINE IMMUNOGLOBULIN/PROTEIN ISOLATE, SBI) REPORTED AT THE ACG 2015 ANNUAL MEETING

New Clinical Data Utilizing EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) for Chronic Loose and Frequent stools in a Variety of Intestinal Conditions Presented at the ACG 2015 Annual Meeting

Entera Health, Inc. today announced results from nine poster presentations at the ACG 2015 Annual Meeting in Honolulu, HI, from Friday, October 16th to Wednesday, October 21st, 2015.

Diarrhea Management

Dr. Christine Frissora (Weill Cornell Medical College, Cornell University, New York, NY) reported on a retrospective chart review of seven patients with refractory microscopic colitis (MC) that were placed on SBI therapy to manage chronic loose and frequent stools. The addition of SBI to ongoing treatment regimens completely managed loose stools in all seven MC patients, and four of the patients with a history of fecal incontinence no longer experienced such episodes after SBI administration. All patients have been managed effectively for over one year without reports of side effects from SBI.

Dr. Michael LeVine (Atlanta Gastroenterology Associates, Atlanta, GA) and Dr. Larry Good (South Nassau Communities Hospital, Oceanside, NY, USA) presented chart reviews on four patients given SBI for antibiotic-associated diarrhea (AAD) following infection with C. difficile. While attempts with other anti-diarrheal medications were unsuccessful, all four patients showed management of loose and frequent stools within 3-14 days after starting SBI therapy. There were no reports of side effects associated with SBI therapy.

Dr. Larry Good (South Nassau Communities Hospital, Oceanside, NY, USA) reported on a patient with severe intractable diarrhea (13-14 watery stools per day) and fecal incontinence (FI) following surgery to create an ileorectal anastomosis. After 2 months of unsuccessful treatment with various anti-diarrheal agents, the patient was placed on SBI therapy. Within one month the patient experienced 3-4 formed stools/day, a decrease in episodes of FI and urgency, and elevations in serum albumin, suggesting improved protein uptake and/or retention.

Dr. Raouf Hilal (University of Central Florida College of Medicine Orlando, FL) conducted a chart review of six patients with chronic pancreatitis or pancreatic insufficiency that were given SBI to determine its effect on chronic loose and frequent stools and other commonly reported symptoms. Follow-up appointments 8-10 weeks later revealed that all patients experienced improved management of at least 2 symptoms (watery and loose stools, bloating, abdominal discomfort, nausea) with 4 of 4 patients reporting complete management of bloating and abdominal discomfort.

Dr. Mark Anderson (Boice-Willis Clinic, Rocky Mount, NC) reported on a patient of his and Dr. Mitchel Mah’moud’s (Duke University School of Medicine, Durham, NC) with a 4-week history of diarrhea (~10 stools/day) both during treatment with Disease Modifying Anti-Rheumatic Drugs (DMARD; e.g. methotrexate) and after DMARDs were discontinued. The patient was placed on SBI nutritional therapy after unsuccessful attempts with anti-diarrheal medications. Eight weeks later the patient reported complete management of stool frequency and consistency and good tolerance of the SBI therapy.

Jason Roy, ARNP, (Central Florida Gastroenterology, Orlando, FL) presented results from a retrospective chart review of eight patients given SBI to help manage chronic intractable diarrhea associated with mastocytic enterocolitis (i.e. abdominal pain and diarrhea correlated with high mast cell localization in the colon). All eight patients reported improvement in symptoms as early as 2-4 weeks, which included improvements in stool consistency and reductions in stool frequency, incontinence, and cramping for better management of their conditions. In addition, SBI was well-tolerated by patients with no reports of adverse events or discontinuation of therapy.

Celiac Disease

Dr. Larry Good (South Nassau Communities Hospital, Oceanside, NY) presented results from a retrospective chart review of a patient with celiac disease and poor adherence to a gluten-free diet to assess the response to SBI when added to her management therapy. The patient presented with abdominal pain, cramping, diarrhea, and rectal bleeding, was diagnosed with colitis and placed on mesalamine (1000 mg/day) and SBI (5 g/day). Within one month of starting therapy, her condition was fully managed as her symptoms had resolved. Her celiac disease and colitis continued to be well managed on SBI and mesalamine nine months later despite reports of poor compliance on a gluten-free diet.

Dr. Satish Iduru (GI Specialists of Houston, Houston, TX) reported on the use of SBI in another patient with celiac disease and a second one with non-celiac gluten sensitivity (NCGS). The first patient had a 5-year history of GERD, possible IBS-D, and recent diagnosis of celiac disease with a 12-year history of abdominal pain/bloating with diarrhea; a gluten-free diet provided only mild relief of these symptoms. The addition of SBI to her therapy led to management of her condition as indicated by reductions in abdominal discomfort, normal stool frequency/consistency and improvement in hemoglobin levels over 6 weeks. The second patient had a 3-month history of watery/semisolid stools (4/day), periumbilical pain, nausea and vomiting; further testing led to a diagnosis of NCGS. The patient was placed on SBI therapy and within 4 weeks had normal stool frequency/consistency (1/day) and no abdominal discomfort, allowing her to return to school and other normal activities.

Hepatic Encephalopathy (HE)

Dr. Fred Fowler (Carolina Digestive Health, Charlotte, NC) presented a case report on nine patients with cirrhosis and mild to moderate overt HE. Eight of the nine patients showed improvement in cognitive function, while five patients showed successful management of asterixis through 3 months following the addition of SBI to their current therapeutic regimen. Only one patient discontinued SBI due to nausea and no other adverse events were reported.     

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 the product website at http://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 women or nursing mothers. The choice to administer EnteraGam® in pregnant women 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

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