Results Of Clinical Data Presented At Digestive Disease Week (DDW), A Premier Gastroenterology Meeting, Support New IBgard® As A New Approach In Managing Irritable Bowel Syndrome (IBS)

WASHINGTON, May 18, 2015 /PRNewswire/ -- IBgard^® was found to be an effective and well-tolerated new approach in the management of Irritable Bowel Syndrome (IBS), according to recent clinical data presented during Digestive Disease Week (DDW), a premier gastroenterology meeting of the American Gastroenterological Association. IBgard^® is a medical food for the dietary management of IBS.  Data from a clinical study of IBgard^® versus placebo in a group of patients with the two most prevalent types of IBS, mixed diarrhea and constipation (IBS-M) and diarrhea predominant (IBS-D), showed that patients who received IBgard^® experienced a statistically significant reduction in total IBS symptoms at 24 hours and at 4 weeks. IBS is a frustrating, underdiagnosed, and undertreated condition characterized by abdominal pain and abnormal bowel habits that affects an estimated 15-20% of the U.S. population.

Importantly, in the randomized, placebo controlled, U.S.- based IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial) study, IBgard^® provided rapid and significant reduction in eight hallmark symptoms of IBS: abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation and gas or mucus. 

The results highlight an advance in the management of IBS because there is currently no cure for IBS and management options are limited.  IBgard^® addresses a largely, unmet medical need for products to manage the symptoms of the disease, especially for IBS patients with mixed diarrhea and constipation (IBS-M) and diarrhea predominant (IBS-D). It is estimated that the majority of the IBS patient population is comprised of the IBS-M and IBS-D sub types.[i]

IBgard^® is specially formulated for the dietary management of IBS and is the first product using a patented, breakthrough technology called Site Specific Targeting (SST^®)  to deliver individually triple-coated, sustained release microspheres of Ultramen^®, an ultra-purified peppermint oil, quickly and reliably to the small intestine where its actions helps manage IBS.

Study authors presented four posters with data from the IBSREST™ study at DDW on May 17-18, 2015. One of these posters was selected by the DDW reviewers for oral presentation at the plenary session and another poster was awarded a "Poster of Distinction."

IBSREST™ Results
"IBgard^® is a breakthrough in targeted delivery technology that provides an important new option in the management of IBS," said Brooks D. Cash[ii], M.D., the lead study author and Professor of Internal Medicine in the Gastroenterology Division at the University of South Alabama. "In IBSREST™, IBgard^® demonstrated an unprecedented reduction in total IBS symptoms at 24 hours and this trend held at 4 weeks. These promising results also included a statistically significant reduction in abdominal pain or discomfort at 24 hours and this trend held at 4 weeks."

Analysis of IBSREST™ data showed that treatment with IBgard^® resulted in:

 Reduction in Total IBS Symptom Score (TISS) at 24 hours and 4 weeks:

• 18.8% reduction of symptoms from baseline at 24 hours. Statistically significant compared to placebo (P=0.0092).
• 39.6 % of symptoms from baseline at 4 weeks. Statistically significant compared to placebo (P=0.0246).

Reduction in Number of Unbearable or Severe Symptoms (high average of frequency and intensity) at 24 hours and 4 weeks:

• 30% reduction in unbearable or severe symptoms from baseline at 24 hours (P=0.0910).
• 66% reduction in unbearable or severe symptoms from baseline at 4 weeks. Statistically significant compared to placebo (P=0.0212).

Reduction in Patient-Reported Unbearable or Severe Abdominal pain Intensity:  

• 45.7% patients reported reduction in unbearable or severe abdominal pain or discomfort from baseline at 24 hours compared to placebo (P=0.3658).
• 79.4% of patients reported reduction in unbearable or severe abdominal pain from baseline at 4 weeks. Statistically significant compared to placebo (P=0.0009).

Reduction Across the Syndrome of Symptoms
One of the scientific posters entitled, "The Syndrome of Symptoms," presented at DDW was awarded a "Poster of Distinction" by the DDW committee reviewers. It showed that IBgard^® was able to effectively address the key symptoms that are most bothersome for patients, such as abdominal pain, urgency, bloating, and pain at evacuation. All four of these symptoms showed statistically significant reductions compared to placebo.

In the study, IBgard^® was well-tolerated with side effects comparable to placebo. In a post-study assessment, 93% of the patients in the IBgard^® treatment arm said they were satisfied with the relief of their IBS symptoms.

Study Design
IBSREST™ was a 4-week, randomized, placebo-controlled, double-blind clinical trial conducted at multiple centers in the U.S. (initiated May 2013; unblinded July 2014).  There were 72 female and male study participants (75% female; 25% male), aged 18-60 (mean age 40.7), with symptoms of IBS-M and IBS-D.  The participants were White (77.8%), Black (19.4%); Asian (1.4%); and 1.4% unreported.  To qualify for entry into the study, patients had to meet the Rome III criteria for IBS-M or IBS-D[iii]. They had to have a TISS >2 on a 0-4 scale and had to be suffering from persistent levels of abdominal pain >4 on a scale of 0 to 10.

Among study participants, 37 patients received placebo (IBS-M, 19; IBS-D, 18) and 35 received IBgard^® (IBS-D, 19; IBS-M, 16). Dosing was 2 capsules with 90 mg peppermint each, 3 times a day.  Before enrollment patients were required to undergo lab testing and washout of all prohibited medicines.  Rescue medications were not allowed. Patients were instructed to keep a 2-week baseline diary. 

The primary analysis of IBSREST™ was for changes in the TISS, a previously studied global symptom measure, as well as the average of the frequency and intensity of the eight symptoms that customarily constitute the IBS syndrome of symptoms: abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation and gas or mucus.

About IBgard^® 
IBgard^® capsules contain L-menthol, the principal component in peppermint oil, which has been shown to have significant impact on the management of IBS symptoms. In multiple clinical studies, peppermint oil has been shown to provide relief from IBS symptoms. With its patented SST^® technology, pioneered by IM HealthScience^®, IBgard^® capsules release Ultramen^®, an ultra-purified peppermint oil, in the small intestine. Peppermint oil can help normalize the digestion of food and absorption of nutrients, which have been compromised by IBS. Peppermint oil has also been shown to normalize intestinal transit time.

IBgard^® microspheres are smaller than 2mm allowing their passage through the pyloric valve during all phases of digestion. Once in the duodenum, the pH-triggered outer coating dissolves and releases Ultramen^® quickly and reliably into the small intestine.   

"IBgard^® harnesses the powerful action of L-menthol, the principal component of peppermint oil. By deploying the novel SST^® technology, it delivers L-menthol quickly and reliably to the small intestine where it is needed most in IBS," said Michael Epstein, M.D., a study author and Chief  Medical Advisor, IM HealthScience^® LLC. "This technology enables the patient to take full advantage of the benefits of peppermint oil without the usual tolerability side effects," he added.

The usual adult dose of IBgard^® is 1-2 capsules as needed, up to three times a day, not to exceed 8 capsules per day. While IBgard^® does not require a prescription; it should be used under medical supervision.

IBgard^® will shortly be accessible (June 2015) to patients on the digestive shelf at most CVS/pharmacy and Walgreens stores nationwide. For more information, visit www.IBgard.com to learn more about IBgard^®.

About IM HealthScience^® 
IM HealthScience^® is a privately held company based in Boca Raton, Florida, that developed IBgard^®. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing medical foods for the dietary management of gastrointestinal issues where there is a high unmet need, including Irritable Bowel Syndrome (IBS), Functional Dyspepsia, Ulcerative Colitis, and Crohn's Disease.  The IM HealthScience^® advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting (SST^®).

Data Presented at DDW

• (Poster Session #Su1372) IBS is a syndrome of inter-related symptoms. The cause is multi-factorial and its epicenter is the small intestine. A U.S.-based, placebo-controlled trial showed that PO's targeted delivery provided significant improvement in the syndrome of symptoms. Dr. Michael S. Epstein (Poster of Distinction)
  • Sunday, May 17, 9:30am. Location: Hall C, Washington Convention Center.
  • Dr. Michael Epstein and Dr. Syed Shah will be available at the poster from noon to 2:00pm.

• (Poster Session #Su1373) IBgard^®, a novel small intestine targeted delivery system of peppermint oil, results in significant improvement in severe and unbearable IBS symptom intensity. Results from a U.S.-based, 4-week, randomized, placebo-controlled, multi-center IBSREST^™ trial. Dr. Brooks D. Cash
  • Sunday, May 17, 9:30am. Location: Hall C, Washington Convention Center.
  • Dr. Michael Epstein and Dr. Syed Shah will be available at the poster from noon to 2:00pm.

• (Research Forum #314) 24-hour results from a placebo-controlled trial, to evaluate a novel peppermint oil delivery system, targeting release in the small intestine. Results from the U.S.-based, 4-week, randomized, placebo-controlled, multi-centered IBSREST^™ trial. Dr. Michael S. Epstein
  • Sunday, May 17, 10:45am, Research Forum. Location: Room 151A, Washington Convention Center.
  • Dr. Michael Epstein will deliver an oral presentation at the Plenary Session.

• (Poster Session #Mo1290)  IBgard^®, a novel targeted delivery system of peppermint oil, results in significant improvement in the Total IBS Symptom Score and individual IBS symptoms. Results from the U.S.-based, 4-week, randomized, placebo-controlled, multi-centered IBSREST^™ trial. Dr. Brooks D. Cash
  • Monday, May 18, 9:30am. Location:  Hall C, Washington Convention Center.
  • Dr. Brooks Cash will be available at the poster from noon to 2:00pm.

For more information about featured studies, as well as a schedule of availability for featured researchers, please visit www.ddw.org/press.

About Digestive Disease Week^® (DDW) 
Digestive Disease Week^® is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, and the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 16–19, 2015, at the Walter E. Washington Convention Center, Washington, DC. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

Regulation of Medical Foods
IBgard^® is a medical food product and not a drug or dietary supplement.  A medical food is defined by section 5(b)(3) of the Orphan Drug Act (21 U.S.C, 360ee (b)(3) as a "food which is formulated to be consumed or administered internally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinct nutritional requirements, based on scientific principles, are established by medical evaluation." Medical foods do not require prior approval by the FDA and are in a unique category separate from drugs or dietary supplements. Medical foods must contain ingredients that are "Generally Recognized As Safe" (GRAS), or are approved food additives, as defined under sections 201(s) and 409 of the Federal Food, Drug and Cosmetic Act.

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SOURCE IM HealthScience

Related Links

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