- IW-3718 Phase IIb Data Selected for the Distinguished
Abstract Plenary Session -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 23, 2018--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology
company, today announced that the company in collaboration with
researchers will present clinical data for IW-3718 during Digestive
Disease Week (DDW) in Washington D.C., June 2 through June 5, 2018.
One of the abstracts will be presented at the Distinguished Abstract
Plenary Session. During this session, Michael Vaezi, Ph.D., M.D., of
Vanderbilt University will share Phase IIb data on the effect of IW-3718
on heartburn and regurgitation – the two most frequent and bothersome
symptoms of gastroesophageal reflux disease (GERD)1 – in
patients with persistent GERD despite treatment with proton pump
inhibitors (PPIs).In addition, data will be presented in
poster sessions highlighting the role of bile acid in persistent GERD;
characteristics of patients who use PPIs and have satisfactory or
unsatisfactory control of their GERD symptoms; and the ex vivo effect of
the bile acid sequestrant colesevelam on the contractile activity of
lower esophageal sphincter muscle, dysfunction of which is believed to
be the most common cause of GERD.2
IW-3718 is being evaluated for the treatment of persistent GERD, with
Phase III trials expected to initiate in the third quarter of 2018.
Persistent GERD is a condition affecting an estimated 10 million
Americans who continue to suffer from heartburn and regurgitation
despite receiving treatment with PPIs, the current standard of care.
Bile acids, which are produced in the intestine and play an important
role in the digestive process, have been implicated in contributing to
GERD symptoms.3,4 The improvement of GERD symptoms observed
in the Phase IIb trial indicates that reflux of intestinal bile acid
from the stomach into the esophagus plays a key role in the ongoing
symptoms of persistent GERD. IW-3718 is a novel formulation of
colesevelam, a bile acid sequestrant designed to release in the stomach
over an extended period of time where it is positioned to intercept bile
before it reaches the esophagus.
The data will be presented as follows:
Distinguished Abstract Plenary Session
Effect of IW-3718 on Heartburn and Regurgitation Symptoms in Patients
with Persistent GERD
- IW-3718, a novel gastric-retentive bile acid sequestrant, improved
heartburn and regurgitation symptoms in patients with persistent GERD
despite PPI treatment: A double-blind, placebo-controlled study
(distinguished abstract plenary presentation #875), by Michael Vaezi,
Ph.D., M.D., Vanderbilt University Medical Center, Nashville, TN, will
be presented at the Esophageal, Gastric & Duodenal Disorders (EGD)
session on Tuesday, June 5, 10:06 a.m. to 10:20 a.m., in Room 201 of
the Washington Convention Center.
Poster Presentations
Role of Bile Acid in GERD
- Presence of bile acids detected in human saliva using a novel
sensitive bioanalytical method: A comparative study in patients with
persistent or controlled GERD symptoms and healthy subjects (poster
session Su1089), by Nisha Perez, Ironwood Pharmaceuticals, Inc.,
Cambridge, MA, will be presented at the GERD: Diagnostic Testing
session on Sunday, June 3, Noon to 2:00 p.m., in Hall C of the
Washington Convention Center.
- Bile acid sequestrant shows effects on the contractile activity of
ex-vivo lower esophageal sphincter muscle (poster session Mo1515),
by Sarah Jacobson, Ironwood Pharmaceuticals, Inc., Cambridge, MA, will
be presented at the Esophageal Motility and Dysmotility session on
Monday, June 4, Noon to 2:00 p.m., in Hall C of the Washington
Convention Center.
Characteristics of GERD Patients with Satisfactory or Unsatisfactory
Symptom Control
- Gastroesophageal reflux disease (GERD) patients taking proton pump
inhibitors: Characteristics of those with satisfactory or
unsatisfactory control of their condition (poster session Sa1097),
by Colin Howden, M.D., The University of Tennessee Health Science
Center, Memphis, TN, will be presented at the GERD: Medical, Surgical
and Endoscopic Therapies session on Saturday, June 2, Noon to 2:00
p.m., in Hall C of the Washington Convention Center.
About IW-3718
IW-3718 is a novel, gastric retentive formulation of colesevelam, a bile
acid sequestrant, developed by Ironwood using the proprietary Acuform®
drug delivery formulation technology licensed from Depomed, Inc.
IW-3718 is designed to deliver the bile acid sequestrant to the stomach
over an extended period of time where it is positioned to intercept bile
before it reaches the esophagus. Data from non-clinical and clinical
studies collectively support the extended release and gastric-retentive
profile of IW-3718. Ironwood has existing patents and pending patent
applications for IW-3718 that are expected to provide patent coverage
into the mid-2030s.
About Persistent Gastroesophageal Reflux Disease (GERD)
An estimated 10 million adult Americans and more than 60 million adult
patients globally suffer from persistent gastroesophageal reflux disease
(GERD), meaning they continue to experience symptoms such as heartburn
and regurgitation despite receiving treatment with a proton pump
inhibitor (PPI). While PPIs suppress production of stomach acid,
Ironwood’s clinical research demonstrates that reflux of bile from the
intestine into the stomach and esophagus plays a key role in the ongoing
symptoms of persistent GERD. FDA-approved treatment options for these
patients are limited.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is a commercial biotechnology
company focused on creating medicines that make a difference for
patients, building value for our fellow shareholders, and empowering our
passionate team. We are commercializing two innovative primary care
products: linaclotide, the U.S. branded prescription market leader for
adults with irritable bowel syndrome with constipation (IBS-C) or
chronic idiopathic constipation (CIC), and lesinurad, which is approved
to be taken with a xanthine oxidase inhibitor (XOI), or as a fixed-dose
combination with allopurinol, for the treatment of hyperuricemia
associated with gout. We are also advancing a pipeline of innovative
product candidates in areas of significant unmet need, including
persistent gastroesophageal reflux disease, diabetic nephropathy, heart
failure with preserved ejection fraction, achalasia and sickle cell
disease. Ironwood was founded in 1998 and is headquartered in Cambridge,
Mass. For more information, please visit www.ironwoodpharma.com or www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely posted
in both these locations.
Forward-Looking Statements
This press release contains forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements, including statements about prevalence of persistent GERD;
the anticipated timing of initiation of the persistent GERD Phase III
trial; and the expected period of patent coverage for IW-3718.
Applicable risks and uncertainties include those related to preclinical
and clinical development, manufacturing and formulation development; the
risk that findings from our completed nonclinical and clinical studies
may not be replicated in later studies; efficacy, safety and
tolerability of IW-3718; decisions by regulatory and judicial
authorities; the risk that we are unable to successfully commercialize
IW-3718, if approved; the risk that we may never get sufficient patent
protection for IW-3718 or that we are not able to successfully protect
such patents; the outcomes in legal proceedings to protect or enforce
the patents relating to our products and product candidates;
developments in the intellectual property landscape; challenges from and
rights of competitors or potential competitors; the risk that our
planned investments do not have the anticipated effect on our company
revenues, products or product candidates; the risk that we are unable to
manage our operating expenses or cash use for operations, or are unable
to commercialize our products, within the guided ranges or otherwise as
expected; and the risks listed under the heading "Risk Factors" and
elsewhere in Ironwood's Quarterly Report on Form 10-Q for the quarter
ended March 31, 2018, and in our subsequent SEC filings. These
forward-looking statements (except as otherwise noted) speak only as of
the date of this press release, and Ironwood undertakes no obligation to
update these forward-looking statements.
1 Vakil, N., Stelwagon M., Shea E.P., & Miller S. (2015).
Symptom Burden and Consulting Behavior in Patients with Overlapping
Functional Disorders in the US Population. United European
Gastroenterology Journal, 4(3), 412-422.
2 Mitre, M. C.,
& Katzka, D. A. (2004). Pathophysiology of GERD: Lower Esophageal
Sphincter defects. Practical Gastroenterology, 28(5), 44-58.
3
Bachir G. S., Leigh-Collis J., Wilson P., & Pollak E. W. (1981).
Diagnosis of incipient reflux esophagitis: a new test. Southern Medical
Journal, 74(9), 1072-4.
4 Vaezi M. F., & Richter J. E.
(1998). Contribution of acid and duodenogastro-oesophageal reflux to
oesophageal mucosal injury and symptoms in partial gastrectomy patients.
Gut, 41, 297-302.
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Source: Ironwood Pharmaceuticals, Inc.
Media and Investors:
Ironwood Pharmaceuticals, Inc.
Meredith
Kaya, 617-374-5082
Vice President, Investor Relations and Corporate
Communications
mkaya@ironwoodpharma.com