CAMBRIDGE, MA, USA I November 4, 2014 I Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today the initiation of a Phase III clinical trial in the U.S. evaluating a 72 mcg capsule of linaclotide to be taken once per day for the treatment of adults suffering from chronic idiopathic constipation (CIC). Linaclotide is currently approved by the U.S. Food and Drug Administration as a 145 mcg capsule to be taken once per day for the treatment of adults with CIC and as a 290 mcg capsule to be taken once per day for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
“The 72 mcg dose of linaclotide may provide physicians with more options that may enable them to better serve their adult chronic idiopathic constipation patients,” said Dr. Michael Hall, senior vice president, clinical development of Ironwood. “The development of this additional dosage strength for linaclotide is part of our broader strategy to explore the ability of our pipeline of guanylate cyclase-C agonists to help millions of patients suffering from gastrointestinal dysfunction.”
Data from the Phase III trial of 72 mcg linaclotide are expected in 2016. The clinical trial is being conducted jointly by Ironwood and Actavis plc, Ironwood’s co-development and co-promotion partner for linaclotide in the United States.
The randomized, double-blind, placebo-controlled, multi-site Phase III clinical trial is expected to enroll approximately 1,200 adult patients with CIC. Patients with CIC have fewer than three spontaneous bowel movements per week, and they also may experience recurrent straining, lumpy or hard stools, and/or a sensation that their bowels are not fully empty. Patients will be randomized to receive 145 mcg of linaclotide once per day, 72 mcg of linaclotide once per day, or placebo once per day for 12 weeks. The primary objective of the trial is to determine the efficacy and safety of linaclotide 72 mcg in adult patients with CIC. The primary efficacy assessment is the percentage of patients who experience at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM from baseline in the same week, and achieve both of these measures for nine out of 12 weeks (12-week CSBM Overall Responder).
About Chronic Idiopathic Constipation
Chronic idiopathic constipation (CIC) is a functional gastrointestinal disorder in which individuals have infrequent bowel movements (less than three times per week) and also may experience recurrent straining, lumpy or hard stools, and/or a sensation that their bowels are not fully empty. While estimates vary, as many as 35 million adult Americans may suffer from CIC. Results derived from responses to a web-based survey commissioned by Forest Pharmaceuticals, now a member of the Actavis Group plc, and Ironwood suggest that only 12 percent of adult CIC sufferers are medically diagnosed. There are few available prescription treatment options for this condition.
About Linaclotide
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that is thought to work in two ways based on nonclinical studies. Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established. Linaclotide is marketed by Ironwood and Actavis in the United States as LINZESS® and is indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Linaclotide is marketed by Almirall, S.A. for the treatment of adults with moderate to severe IBS-C in Europe under the brand name CONSTELLA®. Ironwood also has partnered with Astellas Pharma Inc. for development and commercialization of linaclotide in Japan and with AstraZeneca for development and commercialization in China.
LINZESS and CONSTELLA are trademarks owned by Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is focused on creating medicines that make a difference for patients, building value to earn the continued support of our fellow shareholders, and empowering our team to passionately pursue excellence. We discovered, developed and are commercializing linaclotide, which is approved in the United States and a number of other countries. Our pipeline priorities include exploring further opportunities for linaclotide, as well as leveraging our therapeutic expertise in gastrointestinal disorders and our pharmacologic expertise in guanylate cyclases to address patient needs across the upper and lower gastrointestinal tract. Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. Connect with us at www.ironwoodpharma.com or on Twitter at www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.
SOURCE: Ironwood Pharmaceuticals
Post Views: 107
CAMBRIDGE, MA, USA I November 4, 2014 I Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today the initiation of a Phase III clinical trial in the U.S. evaluating a 72 mcg capsule of linaclotide to be taken once per day for the treatment of adults suffering from chronic idiopathic constipation (CIC). Linaclotide is currently approved by the U.S. Food and Drug Administration as a 145 mcg capsule to be taken once per day for the treatment of adults with CIC and as a 290 mcg capsule to be taken once per day for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
“The 72 mcg dose of linaclotide may provide physicians with more options that may enable them to better serve their adult chronic idiopathic constipation patients,” said Dr. Michael Hall, senior vice president, clinical development of Ironwood. “The development of this additional dosage strength for linaclotide is part of our broader strategy to explore the ability of our pipeline of guanylate cyclase-C agonists to help millions of patients suffering from gastrointestinal dysfunction.”
Data from the Phase III trial of 72 mcg linaclotide are expected in 2016. The clinical trial is being conducted jointly by Ironwood and Actavis plc, Ironwood’s co-development and co-promotion partner for linaclotide in the United States.
The randomized, double-blind, placebo-controlled, multi-site Phase III clinical trial is expected to enroll approximately 1,200 adult patients with CIC. Patients with CIC have fewer than three spontaneous bowel movements per week, and they also may experience recurrent straining, lumpy or hard stools, and/or a sensation that their bowels are not fully empty. Patients will be randomized to receive 145 mcg of linaclotide once per day, 72 mcg of linaclotide once per day, or placebo once per day for 12 weeks. The primary objective of the trial is to determine the efficacy and safety of linaclotide 72 mcg in adult patients with CIC. The primary efficacy assessment is the percentage of patients who experience at least three complete spontaneous bowel movements (CSBMs) per week and an increase of at least one CSBM from baseline in the same week, and achieve both of these measures for nine out of 12 weeks (12-week CSBM Overall Responder).
About Chronic Idiopathic Constipation
Chronic idiopathic constipation (CIC) is a functional gastrointestinal disorder in which individuals have infrequent bowel movements (less than three times per week) and also may experience recurrent straining, lumpy or hard stools, and/or a sensation that their bowels are not fully empty. While estimates vary, as many as 35 million adult Americans may suffer from CIC. Results derived from responses to a web-based survey commissioned by Forest Pharmaceuticals, now a member of the Actavis Group plc, and Ironwood suggest that only 12 percent of adult CIC sufferers are medically diagnosed. There are few available prescription treatment options for this condition.
About Linaclotide
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that is thought to work in two ways based on nonclinical studies. Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established. Linaclotide is marketed by Ironwood and Actavis in the United States as LINZESS® and is indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Linaclotide is marketed by Almirall, S.A. for the treatment of adults with moderate to severe IBS-C in Europe under the brand name CONSTELLA®. Ironwood also has partnered with Astellas Pharma Inc. for development and commercialization of linaclotide in Japan and with AstraZeneca for development and commercialization in China.
LINZESS and CONSTELLA are trademarks owned by Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is focused on creating medicines that make a difference for patients, building value to earn the continued support of our fellow shareholders, and empowering our team to passionately pursue excellence. We discovered, developed and are commercializing linaclotide, which is approved in the United States and a number of other countries. Our pipeline priorities include exploring further opportunities for linaclotide, as well as leveraging our therapeutic expertise in gastrointestinal disorders and our pharmacologic expertise in guanylate cyclases to address patient needs across the upper and lower gastrointestinal tract. Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. Connect with us at www.ironwoodpharma.com or on Twitter at www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.
SOURCE: Ironwood Pharmaceuticals
Post Views: 107
