Ironwood and Forest to Present Linaclotide Phase 3 Chronic Constipation Data
April 26 2010 - 6:48PM
Business Wire
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest
Laboratories, Inc. (NYSE: FRX) today announced they will be
presenting Phase 3 chronic constipation clinical trial results for
linaclotide, an investigational guanylate cyclase type-C (GC-C)
agonist for the treatment of irritable bowel syndrome with
constipation (IBS-C) and chronic constipation (CC), during the 2010
Digestive Disease Week (DDW) annual meeting being held in New
Orleans from May 1 through May 5, 2010. Ironwood and Forest
released the top-line results from the CC trials late last year and
expect to have data from the Phase 3 IBS-C trials in the second
half of 2010.
The linaclotide CC data will be reported in two oral
presentations and one poster presentation. The scheduled times and
titles of the presentations are:
- Efficacy and Safety of Once
Daily Linaclotide Administered Orally for 12-Weeks in Patients with
Chronic Constipation: Results from Two Randomized, Double-blind,
Placebo-controlled Phase 3 Trials, an oral presentation by Anthony
Lembo, M.D. on Monday, May 3 at 8:50 a.m. (CDT)
- Results from the Randomized
Withdrawal Period of a Phase 3 Clinical Trial of Linaclotide in
Chronic Constipation, a poster of distinction presented by Jeffrey
Johnston, M.D., F.A.C.P., F.A.C.G. on Tuesday, May 4 at 12:00 p.m.
– 2:00 p.m. (CDT)
- Effect of Linaclotide on Quality
of Life in Adults with Chronic Constipation: Results from Two
Randomized, Double-Blind, Placebo-Controlled Phase 3 Trials, a
late-breaking, distinguished oral presentation by Robyn Carson,
M.P.H. on Tuesday, May 4 at 4:45 p.m. (CDT)
In addition, Ironwood and Forest will present qualitative
research on symptoms of chronic constipation most important to
patients in a poster session on May 3 at DDW:
- Assessing Treatment Response in
Chronic Constipation Clinical Trials: Concepts Elicited Through
Qualitative Interviews With Patients, a poster presentation
presented by Sheri Fehnel, Ph.D. on Monday, May 3 from 12:00 p.m. –
2:00 p.m. (CDT)
About Linaclotide
Linaclotide, an investigational drug, is an agonist of guanylate
cyclase type-C (GC-C), a receptor found on epithelial cells lining
the intestine. Activation of GC-C leads to increases in
intracellular and extracellular cyclic guanosine monophosphate
(cGMP). In animal models, extracellular cGMP inhibited afferent
nerve firing and positively affected markers of abdominal pain,
while intracellular cGMP led to activation of anion channels which
stimulated anion and fluid section into the intestine, leading to
accelerated intestinal transit. Linaclotide is an orally delivered
peptide that acts locally in the gut with no detectable systemic
exposure at therapeutic doses and is intended for once-daily
administration. Linaclotide is in Phase 3 clinical development for
the treatment of IBS-C and CC. In a Phase 2b study in patients with
IBS-C, linaclotide statistically significantly reduced abdominal
pain, abdominal discomfort, severity of straining, and bloating,
and increased complete spontaneous bowel movement frequency,
throughout the 12-week treatment period versus placebo. In two
Phase 3 trials in patients with CC, statistical significance versus
placebo was achieved for the primary endpoint—increasing complete
spontaneous bowel movements—and all secondary endpoints, which
included measures of straining severity, stool hardness, bloating,
and abdominal discomfort. In Phase 2 IBS-C and Phase 3 CC trials,
diarrhea was the most common adverse event, occurring at an
incidence between 12 percent and 20 percent for linaclotide-treated
patients (at the 133 to 266 mcg dose range) and between 1 percent
and 7 percent for patients receiving placebo. Diarrhea was the most
common cause for discontinuation, although most events of diarrhea
were reported as mild to moderate. Data from the Phase 3 IBS-C
trials are expected in the second half of 2010. An issued
composition of matter patent for linaclotide provides protection to
2025. In September 2007, Ironwood and Forest entered into a 50/50
collaboration to co-develop and co-promote linaclotide in the
United States. Ironwood has out-licensed linaclotide to Almirall
for European development and commercialization, and to Astellas
Pharma for development and commercialization in Japan and other
Asian countries.
About Chronic Constipation (CC)
As many as 34 million Americans suffer from symptoms associated
with CC and 8.5 million patients have sought treatment. 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, as well as discomfort and bloating.
This condition significantly affects patients' quality of life by
impairing their ability to work and participate in typical daily
activities. Half of patients are not satisfied with currently
available treatments.
About Irritable Bowel Syndrome with Constipation (IBS-C)
IBS-C is a chronic functional gastrointestinal disorder
characterized by abdominal pain, discomfort, and bloating
associated with altered bowel habits, and as many as 11 million
people in the U.S. suffer from it. There are currently few
available therapies to treat this disorder and there is a high rate
of dissatisfaction with available therapies. Patients suffering
from IBS-C can be affected physically, psychologically, socially,
and economically.
About Digestive Disease Week (DDW)
DDW 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, the American Gastroenterological Association (AGA)
Institute, the American Society for Gastrointestinal Endoscopy and
the Society for Surgery of the Alimentary Tract, DDW takes place
May 1–5, 2010, at the Ernest N. Morial Convention Center, New
Orleans. The meeting showcases approximately 5,000 abstracts and
hundreds of lectures on the latest advances in GI research,
medicine and technology. For more information, visit
www.ddw.org.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is an entrepreneurial
pharmaceutical company dedicated to the art and science of great
drugmaking. Linaclotide, Ironwood's GC-C agonist, is being
evaluated in a confirmatory Phase 3 program for the treatment of
irritable bowel syndrome with constipation (IBS-C) and chronic
constipation. Ironwood also has a growing pipeline of additional
drug candidates in earlier stages of development. Ironwood is
located in Cambridge, Mass. To learn more about Ironwood
Pharmaceuticals, visit www.ironwoodpharma.com.
About Forest Laboratories, Inc.
Forest Laboratories (NYSE: FRX) is a U.S.-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 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 Report on Form
10-Q, and any subsequent SEC filings.
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