Ironwood and Forest to Present Positive Data From Linaclotide Phase 2b IBS-C Study at ACG Annual Scientific Conference
September 23 2008 - 6:07PM
PR Newswire (US)
- 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. http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO
http://photoarchive.ap.org/ DATASOURCE: Ironwood Pharmaceuticals;
Forest Laboratories, Inc. CONTACT: Susan Brady, Corporate
Communications, Ironwood Pharmaceuticals, +1-617-621-8304, , or
Frank Murdolo, Vice President - Investor Relations, Forest
Laboratories Inc., +1-212-224-6714, Web site: http://www.frx.com/
http://www.ironwoodpharma.com/
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