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Ironwood and AbbVie Report Top-line Phase II Data for MD-7246 in Patients with Abdominal Pain Associated with Irritable Bowel Syndrome with Diarrhea (IBS-D)

– Trial did not achieve statistically significant improvements in abdominal pain relative to placebo –

– Companies plan to discontinue development of MD-7246 –

Ironwood 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.

Forward-Looking Statements

This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about plans to discontinue the development of MD-7246; plans to further examine the MD-7246 Phase II data in IBS-D, including any findings from such further examination; our strategy, business and operations, including with respect to driving LINZESS growth and the Phase III program for IW-3718; the development and commercial potential of LINZESS; the potential benefits of LINZESS and IW-3718 ; and IBS-D symptoms and the size of the potential GI patient population. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Ironwood undertakes no obligation to update these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to effectiveness of development and commercialization efforts by us and our partners; preclinical and clinical development, manufacturing and formulation development; the risk that our clinical programs and studies may not progress or develop as anticipated, including that studies are delayed or discontinued for any reason, such as safety, tolerability, enrollment, manufacturing, economic or other reasons, including due to the impacts of the COVID-19 pandemic; the risk that findings from our completed nonclinical and clinical studies may not be replicated in later studies; efficacy, safety and tolerability of linaclotide and our product candidates; the risk that the therapeutic opportunities for LINZESS or our product candidates are not as we expect; decisions by regulatory and judicial authorities; the risk that we may never get sufficient patent protection for linaclotide and other product candidates, that patents for linaclotide or other products may not provide adequate protection from competition, or that we are not able to successfully protect such patents; the outcomes in legal proceedings to protect or enforce the patents relating to linaclotide and our product candidates, including abbreviated new drug application litigation; the risk that financial and operating results may differ from our projections; developments in the intellectual property landscape; challenges from and rights of competitors or potential competitors; the risk that our planned investments do not have the anticipated effect on our company revenues; the risk that we are unable to manage our expenses or cash use, or are unable to commercialize our products as expected; and the risks listed under the heading "Risk Factors" and elsewhere in Ironwood's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 and in our subsequent SEC filings. In addition, the COVID-19 pandemic and the associated containment efforts have had a serious adverse impact on the economy, the severity and duration of which are uncertain. Government stabilization efforts will only partially mitigate the consequences. The extent and duration of the impact on our business and operations is highly uncertain. Factors that will influence the impact on our business, operations and financial results include the duration and extent of the pandemic, the extent of imposed or recommended containment and mitigation measures, and the general economic consequences of the pandemic. The pandemic could have a material adverse impact on our business, operations and financial results for an extended period of time.

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Contacts

Investors and Media:
Meredith Kaya, 617-374-5082
mkaya@ironwoodpharma.com

Media:
Beth Calitri, 978-417-2031
bcalitri@ironwoodpharma.com