Ironwood & Forest to Present Linaclotide Results from Phase 2B & Phase 3 Trials in Patients with Irritable Bowel Syndrome wit...
October 27 2011 - 8:00AM
Business Wire
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest
Laboratories, Inc. (NYSE: FRX) today announced they will be
presenting additional linaclotide results from four pivotal Phase 3
trials and one Phase 2b study in patients with either irritable
bowel syndrome with constipation (IBS-C) or chronic constipation
(CC) at the American College of Gastroenterology (ACG) 2011 Annual
Scientific Meeting being held in Washington, DC from October 29,
2011 to November 2, 2011. Linaclotide is an investigational
guanylate cyclase type-C (GC-C) agonist for the treatment of IBS-C
and CC. Positive results from each of these trials have been
reported previously.
The linaclotide results will be presented in three poster
presentations as follows:
- Poster P765 describes a pooled analysis
from the two pivotal Phase 3 IBS-C trials. This poster is authored
by Dr. William D. Chey and will be presented on Monday, October 31
from 10:30 a.m. – 4:30 p.m. (Eastern Time).
- Poster P764 describes a pooled analysis
of patients with at least moderate bloating from the two pivotal
Phase 3 CC trials. This poster is authored by Dr. Anthony Lembo and
will be presented on Monday, October 31 from 10:30 a.m. – 4:30 p.m.
(Eastern Time).
- Poster P1170 provides an assessment of
endpoints used in evaluating treatments for IBS-C and is based on
the Phase 2b IBS-C clinical study of linaclotide. This poster is
authored by Dr. Jeff Johnston and will be presented on Tuesday,
November 1 from 10:30 a.m. – 4:30 p.m. (Eastern Time).
About Linaclotide
Linaclotide, an investigational drug, is an agonist of the
guanylate cyclase type-C (GC-C) receptor located on the luminal
surface of the intestine. In preclinical models, linaclotide
reduced visceral hypersensitivity, increased fluid secretion, and
accelerated intestinal transit. The effects on secretion and
transit are mediated through cyclic guanosine monophosphate (cGMP),
which is also believed to modulate the activity of local nerves to
reduce pain. Linaclotide is an orally delivered peptide that acts
locally in the gut with no measurable systemic exposure at
therapeutic doses and is intended for once-daily administration. An
issued composition of matter patent for linaclotide provides
protection to 2025 in the United States. Ironwood and Forest plan
to co-promote linaclotide in the U.S. Ironwood has out-licensed
linaclotide to Almirall for European development and
commercialization, and to Astellas Pharma Inc. for development and
commercialization in Japan, Indonesia, Korea, the Philippines,
Taiwan, and Thailand.
About Irritable Bowel Syndrome with Constipation
(IBS-C)
IBS-C is a chronic functional gastrointestinal disorder
characterized by abdominal pain, abdominal discomfort, and bloating
associated with altered bowel habits, and as many as 11 million
people in the U.S. suffer from it. IBS-C can have a negative impact
on daily living. There are currently few available therapies to
treat this disorder.
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 abdominal discomfort and
bloating. There is a high rate of dissatisfaction with currently
available treatments for CC.
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 an
investigational drug for the treatment of irritable bowel syndrome
with constipation (IBS-C) and chronic constipation (CC). The
efficacy portion of linaclotide’s development program has been
completed and supports the recently submitted NDA submission for
both indications, as well as the MAA submission in Europe for the
IBS-C indication. Ironwood also has a growing pipeline of
additional drug candidates in earlier stages of development.
Ironwood is located in Cambridge, Mass. To learn more, visit
www.ironwoodpharma.com.
About Forest Laboratories, Inc.
Forest Laboratories’ (NYSE: FRX) longstanding global
partnerships and track record developing and marketing
pharmaceutical products in the United States have yielded its
well-established central nervous system and cardiovascular
franchises and innovations in anti-infective and respiratory
medicine. The Company’s pipeline, the most robust in its history,
includes product candidates in all stages of development across a
wide range of therapeutic areas. The Company is headquartered in
New York, NY. To learn more, 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 each of
Forest's and Ironwood's Annual Reports on Form 10-K, Quarterly
Reports on Form 10-Q, and other SEC filings. Neither Forest nor
Ironwood undertakes any obligation (and neither intends to update)
these forward-looking statements to reflect events or circumstances
occurring after this press release. These forward-looking
statements speak only as of the date of this press release. All
forward-looking statements are qualified in their entirety by this
cautionary statement.
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