- Comprehensive Phase 3 Clinical Program Initiated -
CAMBRIDGE, Mass. and NEW YORK, Sept. 23 /PRNewswire-FirstCall/ --
Ironwood Pharmaceuticals (formerly Microbia) and Forest Laboratories, Inc.
(NYSE: FRX) today announced they will present results of a Phase 2b study
investigating linaclotide's safety and efficacy in 419 patients with
irritable bowel syndrome with constipation (IBS-C) in a plenary session at
the American College of Gastroenterology (ACG) 2008 Annual Scientific
Meeting in Orlando, Fla. on October 7, 2008. Analysis of these data
indicated that the study met its primary endpoint. Linaclotide is a
first-in-class investigational compound being evaluated for its potential
to treat IBS-C, chronic constipation (CC), and other gastrointestinal
disorders.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
Ironwood and Forest also announced that they have initiated a
comprehensive Phase 3 clinical program to evaluate linaclotide's safety and
efficacy in patients with either IBS-C or CC. The program will include two
pivotal trials in IBS-C patients and two pivotal trials in CC patients,
enrolling over 2,500 patients at approximately 250 clinical centers. The
companies recently began patient dosing in the first CC trial and expect to
initiate the second CC trial by the end of September, 2008. The companies
expect to initiate both IBS-C trials by January, 2009.
IBS-C Phase 2b Study
This U.S. and Canada based, twelve-week, randomized, double-blind,
placebo-controlled Phase 2b study was designed to assess the safety,
efficacy, and dose-response of linaclotide in patients with IBS-C. Patients
were randomized to receive placebo or linaclotide once-daily in the morning
at doses of 75 mcg, 150 mcg, 300 mcg or 600 mcg. The companies released an
interim analysis of the study results in March. The completed results to be
presented at the ACG conference affirm this earlier analysis. In this
study, the change from baseline vs. placebo for complete spontaneous bowel
movement (CSBM) frequency-the study's primary endpoint-was significant at
all linaclotide dose levels. Notably, abdominal pain was clinically and
statistically significantly reduced in all linaclotide treatment groups
compared to placebo. Linaclotide-treated patients also experienced
improvements in all other top-line efficacy endpoints-spontaneous bowel
movement (SBM) frequency, stool consistency, bloating, abdominal
discomfort, adequate relief, and IBS-C symptom severity-and these
improvements were statistically significant for at least three of the four
linaclotide dose groups for each endpoint. Linaclotide was well tolerated
at all doses. The most common adverse event was diarrhea; however, there
were no associated dehydration or electrolyte abnormalities, and
discontinuations due to diarrhea were infrequent.
About Linaclotide
Linaclotide is a first-in-class compound currently being evaluated for
the treatment of IBS-C, CC, and other gastrointestinal disorders. In Phase
2b studies in patients with IBS-C, linaclotide reduced abdominal pain and
relieved constipation-the hallmarks of the condition-throughout the 12-week
treatment period. Patients with CC who received linaclotide in Phase 2b
studies experienced a significant improvement in bowel function as well.
Linaclotide was well tolerated at all doses, with the most common adverse
event being diarrhea. Positive results from a linaclotide Phase 2b study in
310 patients with CC were detailed in May 2008 at the Digestive Disease
Week conference in San Diego. 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. In preclinical testing, linaclotide was shown to decrease
visceral pain, increase fluid secretion into the intestine, and accelerate
intestinal transit. 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% to 40% 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
$231 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 Ironwood Pharmaceuticals; Forest Laboratories, Inc.
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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:
Susan Brady, Corporate Communications,
Ironwood Pharmaceuticals, +1-617-621-8304,
sbrady@ironwoodpharma.com, or Frank Murdolo, Vice President -
Investor Relations, Forest Laboratories Inc., +1-212-224-6714,
frank.murdolo@frx.com
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