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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)
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In a group of IBS-M and IBS-D patients, IBgard® reduced eight hallmark symptoms
of IBS in as early as 24 hours and further reduced these symptoms at 4 weeks
Patented Site Specific Targeting (SST®) technology delivers peppermint oil in
microspheres to the small intestine
A scientific abstract on the 24-hour results highlighting rapid relief of IBS
symptoms with IBgard® was selected for an oral presentation at the DDW Plenary
Session
A scientific abstract highlighting the ability of IBgard® to address the syndrome of
symptoms of IBS was awarded a “Poster of Distinction”
WASHINGTON, D.C. – (May 18, 2015) – IBgard® was found to be an effective and welltolerated 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.
1 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.1
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 1718, 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. Cash2, 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
1Drossman
2
et al. J. Clin.Gastroenterol. 2009:43(6) 541-550.
Consultant for IM HealthScience.
2 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-D3. 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.
3 http://www.romecriteria.org/criteria/
3 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)
o Sunday, May 17, 9:30am. Location: Hall C, Washington Convention Center.
o Dr. Michael Epstein and Dr. Syed Shah will be available at the poster from noon to
2:00pm.
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(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
o Sunday, May 17, 9:30am. Location: Hall C, Washington Convention Center.
o Dr. Michael Epstein and Dr. Syed Shah will be available at the poster from noon
to 2:00pm.
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(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
o Sunday, May 17, 10:45am, Research Forum. Location: Room 151A, Washington
Convention Center.
o Dr. Michael Epstein will deliver an oral presentation at the Plenary Session.
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(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, multicentered IBSREST™ trial. Dr. Brooks D. Cash
o Monday, May 18, 9:30am. Location: Hall C, Washington Convention Center.
o 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.
4 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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