– Trial did not achieve statistically significant improvements in abdominal pain relative to placebo –
– Companies plan to discontinue development of MD-7246 –
BOSTON, MA, USA I May 27, 2020 IIronwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today announced top-line data from a Phase II trial evaluating MD-7246 in adult patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D). The Phase II trial did not meet its primary or key secondary endpoints. Based on these findings, Ironwood and AbbVie plan to discontinue the development of MD-7246.
Results from a previously announced MD-7246 Phase II trial in adult patients with IBS with constipation (IBS-C) showed that MD-7246 numerically improved abdominal pain relative to placebo with no effect on bowel function. These data informed the companies’ decision to evaluate MD-7246 in the IBS-D population. Ironwood and AbbVie are now further examining the MD-7246 Phase II data in IBS-D to understand the discordance with the improvement in pain observed in the previous IBS-C results.
“We are disappointed by the results from this study; developing new and important treatment options for patients with GI diseases is a critical, but challenging undertaking. We are very grateful to the patients, investigators and researchers who participated, as well as to the Ironwood team and to our partner for executing a robust Phase II trial,” said Mark Mallon, chief executive officer of Ironwood. “Ironwood remains unwavering in its mission of advancing the treatment of GI diseases and redefining the standard of care for millions of GI patients. Ironwood is focused on continuing to drive strong LINZESS growth and completing the Phase III clinical program for IW-3718 in refractory gastroesophageal reflux disease, both of which we believe have the opportunity to help millions of GI patients in need.”
MD-7246 was generally well-tolerated in the Phase II trial in IBS-D; most adverse events were mild to moderate in severity. The most common adverse event for MD-7246 in this Phase II trial was upper respiratory tract infection/nasopharyngitis, which was observed at a similar frequency as placebo. In the Phase II trial in IBS-D, patients taking MD-7246 experienced no clinically meaningful effect on bowel function. Full results from this Phase II trial are expected to be submitted for presentation at a future medical meeting.
MD-7246 Phase II IBS-D Trial Design
The randomized, double-blind, placebo-controlled, parallel-group, dose-range-finding Phase II study was designed to evaluate the safety, tolerability, treatment effect on abdominal pain, and dose response of MD-7246 administered orally to adult patients with abdominal pain associated with IBS-D. 388 IBS-D patients were randomized equally across three dose levels of MD-7246 (300, 600 or 1,200 mcg), or matching placebo, administered once daily. The primary efficacy endpoints were change from baseline in abdominal pain at its worst each week and an overall abdominal pain response, defined as at least a 30% reduction from baseline in abdominal pain for at least 6 out of 12 weeks.
For additional information about this clinical trial, please visit www.clinicaltrials.gov.
Previous MD-7246 Phase II Results in IBS-C
In December 2016, Ironwood reported top-line results from a Phase II clinical trial evaluating MD-7246 in adult patients with irritable bowel syndrome with constipation (IBS-C). Results from the double-blind, placebo-controlled, dose-ranging Phase IIb trial showed that MD-7246 numerically improved abdominal pain and other abdominal symptoms, such as bloating and discomfort, relative to placebo, with no effect on bowel movement function. Percent change from baseline at week 12 in abdominal pain ranged from -33.8% to -36.6% for the MD-7246 doses compared to -26.2% for placebo. The most common adverse event in MD-7246 patients was anemia. The rate of diarrhea reported in the trial ranged from 0% to 3% for MD-7246-treated patients compared to 1.5% for placebo.
About MD-7246
MD-7246 is a delayed release formulation of linaclotide that was being evaluated by Ironwood and its partner AbbVie as an oral, non-opioid, pain-relieving agent for adult patients in the U.S. suffering from abdominal pain associated irritable bowel syndrome with diarrhea (IBS-D). MD-7246 was designed to provide targeted delivery of linaclotide to the colon, where the majority of the abdominal pain associated with IBS is believed to originate, and to limit fluid secretion in the small intestine resulting in minimal impact on bowel function.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a GI-focused healthcare company dedicated to creating medicines that make a difference for patients living with GI diseases. We discovered, developed and are commercializing linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). We are also advancing IW-3718, a gastric retentive formulation of a bile acid sequestrant being developed for the potential treatment of refractory gastroesophageal reflux disease. IW-3718 is first-in-category product candidate currently in Phase III clinical trials.
Ironwood was founded in 1998 and is headquartered in Boston, Mass. For more information, please visit our website at www.ironwoodpharma.com or www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.
LINZESS® is a registered trademark of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved.
SOURCE: Ironwood Pharmaceuticals
Post Views: 32
– Trial did not achieve statistically significant improvements in abdominal pain relative to placebo –
– Companies plan to discontinue development of MD-7246 –
BOSTON, MA, USA I May 27, 2020 IIronwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today announced top-line data from a Phase II trial evaluating MD-7246 in adult patients with abdominal pain associated with irritable bowel syndrome with diarrhea (IBS-D). The Phase II trial did not meet its primary or key secondary endpoints. Based on these findings, Ironwood and AbbVie plan to discontinue the development of MD-7246.
Results from a previously announced MD-7246 Phase II trial in adult patients with IBS with constipation (IBS-C) showed that MD-7246 numerically improved abdominal pain relative to placebo with no effect on bowel function. These data informed the companies’ decision to evaluate MD-7246 in the IBS-D population. Ironwood and AbbVie are now further examining the MD-7246 Phase II data in IBS-D to understand the discordance with the improvement in pain observed in the previous IBS-C results.
“We are disappointed by the results from this study; developing new and important treatment options for patients with GI diseases is a critical, but challenging undertaking. We are very grateful to the patients, investigators and researchers who participated, as well as to the Ironwood team and to our partner for executing a robust Phase II trial,” said Mark Mallon, chief executive officer of Ironwood. “Ironwood remains unwavering in its mission of advancing the treatment of GI diseases and redefining the standard of care for millions of GI patients. Ironwood is focused on continuing to drive strong LINZESS growth and completing the Phase III clinical program for IW-3718 in refractory gastroesophageal reflux disease, both of which we believe have the opportunity to help millions of GI patients in need.”
MD-7246 was generally well-tolerated in the Phase II trial in IBS-D; most adverse events were mild to moderate in severity. The most common adverse event for MD-7246 in this Phase II trial was upper respiratory tract infection/nasopharyngitis, which was observed at a similar frequency as placebo. In the Phase II trial in IBS-D, patients taking MD-7246 experienced no clinically meaningful effect on bowel function. Full results from this Phase II trial are expected to be submitted for presentation at a future medical meeting.
MD-7246 Phase II IBS-D Trial Design
The randomized, double-blind, placebo-controlled, parallel-group, dose-range-finding Phase II study was designed to evaluate the safety, tolerability, treatment effect on abdominal pain, and dose response of MD-7246 administered orally to adult patients with abdominal pain associated with IBS-D. 388 IBS-D patients were randomized equally across three dose levels of MD-7246 (300, 600 or 1,200 mcg), or matching placebo, administered once daily. The primary efficacy endpoints were change from baseline in abdominal pain at its worst each week and an overall abdominal pain response, defined as at least a 30% reduction from baseline in abdominal pain for at least 6 out of 12 weeks.
For additional information about this clinical trial, please visit www.clinicaltrials.gov.
Previous MD-7246 Phase II Results in IBS-C
In December 2016, Ironwood reported top-line results from a Phase II clinical trial evaluating MD-7246 in adult patients with irritable bowel syndrome with constipation (IBS-C). Results from the double-blind, placebo-controlled, dose-ranging Phase IIb trial showed that MD-7246 numerically improved abdominal pain and other abdominal symptoms, such as bloating and discomfort, relative to placebo, with no effect on bowel movement function. Percent change from baseline at week 12 in abdominal pain ranged from -33.8% to -36.6% for the MD-7246 doses compared to -26.2% for placebo. The most common adverse event in MD-7246 patients was anemia. The rate of diarrhea reported in the trial ranged from 0% to 3% for MD-7246-treated patients compared to 1.5% for placebo.
About MD-7246
MD-7246 is a delayed release formulation of linaclotide that was being evaluated by Ironwood and its partner AbbVie as an oral, non-opioid, pain-relieving agent for adult patients in the U.S. suffering from abdominal pain associated irritable bowel syndrome with diarrhea (IBS-D). MD-7246 was designed to provide targeted delivery of linaclotide to the colon, where the majority of the abdominal pain associated with IBS is believed to originate, and to limit fluid secretion in the small intestine resulting in minimal impact on bowel function.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a GI-focused healthcare company dedicated to creating medicines that make a difference for patients living with GI diseases. We discovered, developed and are commercializing linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). We are also advancing IW-3718, a gastric retentive formulation of a bile acid sequestrant being developed for the potential treatment of refractory gastroesophageal reflux disease. IW-3718 is first-in-category product candidate currently in Phase III clinical trials.
Ironwood was founded in 1998 and is headquartered in Boston, Mass. For more information, please visit our website at www.ironwoodpharma.com or www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.
LINZESS® is a registered trademark of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved.
SOURCE: Ironwood Pharmaceuticals
Post Views: 32
