Case Report on the Use of Oral Immunoglobulins in Patients with Colitis

Entera Health, Inc. Announces the Publication of a Case Report on the Use of Orally Administered Serum-Derived Bovine Immunoglobulin/Protein Isolate (SBI) in Patients with Colitis

Entera Health, Inc. announced today the publication of a clinical case report in the Journal of Gastrointestinal & Digestive Systems that describes the use of EnteraGam® (serum-derived bovine immunoglobulin/protein isolate, SBI) as a nutritional therapy to help manage clinical symptoms in two patients with colitis. The first patient had been diagnosed with ischemic colitis a year earlier and presented with intractable, chronic, watery diarrhea and fecal incontinence. After 4 weeks of SBI therapy (5 g QD), the patient reported satisfactory management of her cramping, urgency and chronic loose and frequent stools. The second patient was diagnosed with pan ulcerative colitis in 2012 and continued to experience repeated flares of cramping, diarrhea and rectal bleeding, despite attempts over an 8-month period to manage symptoms with steroids, mesalamine, and antibiotics. After 8 weeks on SBI therapy (5 g BID), the patient reported satisfaction with management of his chronic loose and frequent stools and reported no other symptomatology. The patient was reported to be in complete clinical and endoscopic remission while on adalimumab, oral mesalamine and SBI 5g QD for the past year.

The retrospective chart review was conducted on two patients who had been diagnosed with colitis and were refractory to other conventional therapeutic agents for nearly a year prior to being placed on SBI therapy. Patient-reported outcomes and satisfaction surveys of the current management of their colitis were collected and follow up colonoscopies conducted approximately one year after initiating and continuing SBI therapy for comparison to earlier colonoscopies. Both patients showed resolved colitis during routine colonoscopies performed at least one year after they had included SBI in their regimens. Authors include: Amir Awad, MD (Westchase Gastroenterology, Tampa, FL) and Victoria Jasion, PhD (Cary, NC).

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About Inflammatory Bowel Disease (IBD)

Inflammatory Bowel Disease (IBD) is a chronic inflammatory condition resulting from an immune dysregulation of the intestinal tract, the cause of which remains to be determined[1]. In the US alone, it is estimated that IBD affects more than 1.6 million individuals [2]. The immune dysregulation that occurs in patients with IBD results in two distinct disease states: ulcerative colitis (UC) and Crohn’s disease (CD). Ulcerative colitis is a disease of unknown etiology that produces chronic inflammation of the colon, whereas CD is relapsing inflammatory condition affecting any part of the gastrointestinal tract. Patients with UC often present with symptoms of bloody loose stools, abdominal cramps, and fatigue [3], while patients with CD frequently present with symptoms of abdominal pain, fever, and clinical signs of bowel obstruction or bloody loose stools or mucus [4]. Evidence suggests that many factors contribute to IBD, which partly explains why current treatment methods target the clinical symptoms associated with the inflammatory and immune response in an effort to avoid the need for surgery and address complications associated with IBD [1]. Since there is no cure for IBD, current treatment goals recommended by the Crohn’s and Colitis Foundation of America are to induce remission, maintain remission by preventing flare-ups, and improve overall quality of life.

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

Citations
1. Levesque, B.G., et al. (2015) Converging goals of treatment of inflammatory bowel disease from clinical trials and practice. Gastroenterology 148: 37-51.
2. Baumgart, D.C., and W.J. Sandborn. (2012) Crohn's disease. Lancet 380: 1590-1605
3. Crohn’s and Colitis Foundation of America. (2014) The facts about inflammatory bowel disease 1-20.
4. Danese, S, and C. Fiocchi. (2011) Ulcerative colitis. N Engl J Med 365: 1713-1725.

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