- Data Presented Today at ACG Annual Scientific Meeting -
ORLANDO, Fla., Oct. 7 /PRNewswire-FirstCall/ -- Ironwood
Pharmaceuticals, Inc. (formerly Microbia, Inc.) and Forest Laboratories,
Inc. (NYSE: FRX) today announced the presentation of results from a Phase
2b study assessing linaclotide's safety and efficacy in 420 patients with
irritable bowel syndrome with constipation (IBS-C). Analysis of the data
indicates that once- daily oral dosing of linaclotide, across a range of
doses, significantly reduced abdominal pain and significantly improved
constipation symptoms in patients with IBS-C throughout the 12-week study
period. Further, the safety and tolerability profile support advancing this
novel compound into Phase 3 clinical trials. The study results were
presented today in a plenary session at the American College of
Gastroenterology (ACG) 2008 Annual Scientific Meeting in Orlando, Fla.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
"Patients with IBS-C are in need of effective and well tolerated
therapies. The results of this study showing improvement in abdominal pain
and constipation are encouraging," said Douglas Drossman, M.D., Professor
of Medicine and Psychiatry at UNC School of Medicine, Division of
Gastroenterology and Hepatology and Co-Director of the UNC Center for
Functional GI & Motility Disorders, University of North Carolina at Chapel
Hill, N.C.
Study Results
420 patients were randomized into the study and 337 completed the
12-week treatment period. At all linaclotide dose levels, the change from
baseline vs. placebo for complete spontaneous bowel movement (CSBM)
frequency-the study's primary endpoint-was clinically and statistically
significant (2.5 to 3.6 vs. 1.0; p = 0.0036 to <0.0001). In addition,
abdominal pain was clinically and statistically significantly reduced in
all linaclotide treatment groups compared to placebo (-0.7 to -0.9 change
from baseline on a 5-point ordinal severity scale vs. -0.5; p = 0.0239 to
<0.0001) and, in the 26 percent of patients with severe/very severe
baseline abdominal pain, improvement was even more pronounced (-0.8 to -1.3
v -0.2; p = 0.0236 to <0.0001). Results for spontaneous bowel movement
(SBM) frequency, stool consistency, straining, abdominal discomfort,
bloating, IBS symptom severity, and global assessments were statistically
significant for the 300 ug and 600 ug dose groups and for at least one of
the two lower doses for each endpoint. Treatment effects of linaclotide
were rapid in onset (within the first week of treatment) and were
maintained throughout the entire 12-week treatment period; there was no
indication of rebound clinical effects following cessation of treatment.
Linaclotide was well tolerated at all doses with no treatment-related
serious adverse events. The most common adverse event was diarrhea;
however, there were no associated dehydration or electrolyte abnormalities.
Diarrhea resulted in the discontinuation of 1 percent to 7 percent of
linaclotide-treated patients and none of the placebo-treated patients.
This study was part of a larger Phase 2 program investigating the
effect of linaclotide treatment on patients with IBS-C or chronic
constipation (CC). Ironwood and Forest previously announced the results
from the Phase 2b CC study and have initiated two pivotal Phase 3 CC trials
and expect to initiate two pivotal Phase 3 IBS-C trials by January 2009.
IBS-C Phase 2b Study Design
This North American-based, randomized, multi-center, double-blind,
placebo-controlled, dose-range-finding, parallel-group Phase 2b study was
designed to assess the safety, efficacy, and dose response of linaclotide
in patients with IBS-C. The primary efficacy endpoint was change from
baseline in CSBM frequency. The study evaluated the effects of 75, 150, 300
or 600 ug linaclotide or placebo administered orally once daily to adults
meeting modified Rome II criteria for IBS-C. Participants underwent
two-week-baseline, 12-week-treatment, and two-week-post-treatment
evaluations with daily assessments of bowel habits and symptom severity,
and weekly global assessments using an interactive voice response system.
During the baseline period patients had to demonstrate <3 CSBM/week and
mean daily abdominal pain of at least mild severity. Treatment effects in
the intent-to-treat population were estimated using an analysis of
covariance and the Cochran-Mantel Haenszel test.
About Linaclotide
Linaclotide is a first-in-class compound currently being evaluated for
the treatment of IBS-C, CC, and other gastrointestinal disorders.
Linaclotide was designed to exert its effect on the intestine with minimal
systemic exposure. Linaclotide is an agonist of guanylate cyclase type-C, a
receptor found on the lining of the intestine. Linaclotide demonstrated
proof of concept in a comprehensive Phase 2b program, comprised of two
clinical studies in over 700 patients with either IBS-C or CC. In patients
with IBS-C, linaclotide reduced abdominal pain and relieved
constipation-the hallmarks of the condition- throughout the 12-week
treatment period. In patients with CC, linaclotide reduced constipation
throughout the 4-week study period. Linaclotide was well tolerated at all
doses in both Phase 2b studies, with the most common adverse event being
diarrhea. A United States patent covering linaclotide composition of matter
expires in 2025. In September 2007, Ironwood and Forest Laboratories
entered into a 50/50 collaboration to co-develop and co-promote linaclotide
in the United States. Ironwood retains exclusive rights to linaclotide
outside of North America.
About Irritable Bowel Syndrome (IBS)
One out of six adults in developed countries suffers from IBS, a
chronic condition marked by abdominal pain and disturbed bowel function.
IBS accounts for 12% of adult visits to primary care physicians and is the
most common disorder diagnosed by gastroenterologists. Healthcare costs
associated with IBS exceed $25 billion annually. IBS patients fall largely
into three subgroups-constipation-predominant (IBS-C), diarrhea-predominant
(IBS-D), and mixed IBS (IBS-M)-and 30 percent to 40 percent of these
patients suffer from IBS-C. There are currently few available therapies to
treat the nine million U.S. patients diagnosed with IBS-C.
About Chronic Constipation (CC)
As many as 26 million Americans suffer from CC. Patients with CC often
experience hard and lumpy stools, straining during defecation, a sensation
of incomplete evacuation, and fewer than three bowel movements per week.
The discomfort of CC significantly affects patients' quality of life by
impairing their ability to work and participate in typical daily
activities.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (formerly Microbia) (http://www.ironwoodpharma.com)
is an entrepreneurial pharmaceutical company dedicated to the science and
art of great drugmaking. The Company is advancing several clinical
candidates-linaclotide for the treatment of irritable bowel syndrome with
constipation, chronic constipation, and other functional gastrointestinal
disorders; and novel, next-generation cholesterol absorption inhibitors for
the treatment of hypercholesterolemia. Ironwood also has a growing pipeline
of additional drug candidates in earlier stages of development. Microbia
Precision Engineering, Inc., a majority-owned subsidiary of Ironwood, is an
industrial biotechnology company developing and commercializing novel
bioprocesses for the production of specialty chemicals. Ironwood has raised
$281 million in private equity financing and is located in Cambridge,
Massachusetts.
About Forest Laboratories Inc. and Its Products
Forest Laboratories (NYSE: FRX) is a US-based pharmaceutical company
with a long track record of building partnerships and developing and
marketing products that make a positive difference in people's lives. In
addition to its well-established franchises in therapeutic areas of the
central nervous and cardiovascular systems, Forest's current pipeline
includes product candidates in all stages of development and across a wide
range of therapeutic areas. The company is headquartered in New York, NY.
To learn more about Forest Laboratories, visit http://www.FRX.com.
Except for the historical information contained herein, this release
contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a number
of risks and uncertainties, including the difficulty of predicting FDA
approvals, the acceptance and demand for new pharmaceutical products, the
impact of competitive products and pricing, the timely development and
launch of new products, and the risk factors listed from time to time in
Forest Laboratories' Annual Report on Form 10-K, Quarterly Reports on Form
10-Q, and any subsequent SEC filings.
SOURCE Forest Laboratories, Inc.; Ironwood Pharmaceuticals
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Related links:
http://www.frx.com
http://www.ironwoodpharma.com
Photo Notes:
NewsCom: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, photodesk@prnewswire.com
CONTACT:
Frank Murdolo, Vice President - Investor
Relations of Forest Labs, +1-212-224-6714, frank.murdolo@frx.com;
Susan Brady, Corporate Communications of Ironwood,
+1-617-621-8304, sbrady@ironwoodpharma.com
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