More than 90% of Surveyed IBS-C Patients Who Had an ER Visit or Hospitalization in the Past Year Identified Abdominal Pain as a Symptom That Led to the Visit, According to Data Announced by Ironwood Pharmaceuticals at ACG 2021

- Ironwood to Also Present Data Highlighting Impact of Linaclotide on Abdominal and Bowel-Related Symptoms in Adult Patients with IBS-C -

- Separate Surveys Will Highlight Disease Prevalence and Burden Among Patients with GI Conditions -

BOSTON--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, will present new findings at the American College of Gastroenterology (ACG) 2021 Annual Scientific Meeting and Postgraduate Course from a survey highlighting prevalence and impact of abdominal symptoms in adult patients with irritable bowel syndrome with constipation (IBS-C).

The poster, titled Prevalence and Impact of Abdominal Symptoms in Patients With IBS-C (P1433) will be presented today, Oct. 25 from 10:30 a.m. to 4:15 p.m. PT. The poster summarizes data from a cross-sectional, on-line, general health survey of 16,325 adults conducted from August 2020 to March 2021. Of the survey participants, 449 patients self-identified and met Rome IV criteria for IBS-C.

Fifty six out of 449 IBS-C patients (12.5%) reported an emergency room visit or hospitalization within the last 12 months, mostly driven by their abdominal symptoms: abdominal pain (91.1%), abdominal discomfort (60.79%) and bloating (42.9%). Additionally, 75.4% of these IBS-C patients cited abdominal pain as a symptom that led to medication use, followed by abdominal discomfort (70.4%).

“IBS-C is a complicated condition that involves more than constipation, and while patients don’t always verbalize their abdominal symptoms, this survey bolsters previous research that suggest these symptoms – including abdominal bloating, pain, and discomfort - have a considerable impact on their daily lives,” said Brian E. Lacy, M.D., Ph.D., Professor of Medicine, Mayo Clinic Jacksonville. “The fact that abdominal pain, discomfort and bloating are driving IBS-C patients into the ER or causing them to be hospitalized makes it imperative for physicians like myself to expressly ask patients about their abdominal symptoms so these symptoms can be given the attention they deserve.”

Other key findings of the survey include:

- Of all surveyed IBS-C patients who had seen a health care provider for their symptoms in the past 12 months, 33.9% (n=254) reported inadequate relief and/or worsening abdominal symptoms as a reason for their visit.
- Overall, more than half of surveyed IBS-C patients currently taking a prescription (Rx) or over-the-counter (OTC) treatment reported being dissatisfied with the control of their abdominal symptoms.
- Surveyed IBS-C patients were equally dissatisfied with the control of their abdominal symptoms (49.0%) and bowel-related symptoms (48.8%).
- Surveyed patients currently taking a Rx medication (n=103) were more satisfied with the control of their abdominal symptoms (40.8% vs. 20.7%) and bowel-related symptoms (41.7% vs. 23.9%) than surveyed patients currently taking an OTC (n=213).

Ironwood also announced an oral presentation and four other posters at the meeting. Two of the posters highlight the impact of linaclotide on abdominal and bowel-related symptoms in adult patients with IBS-C. The other two posters - one of which received the ACG’s Presidential Poster Award - and the oral presentation summarize GI disease prevalence and burden.

“GI diseases like IBS-C and CIC are surprisingly complex, with overlapping symptoms that can cause challenges with the physician-patient dialogue,” said Mike Shetzline, M.D., Ph.D., chief medical officer, senior vice president and head of research and drug development at Ironwood. “We are optimistic that our research presented at ACG will arm physicians with additional tools to navigate conversations with their adult IBS-C and CIC patients about their symptoms and treatment.”

Impact of Linaclotide on Abdominal and Bowel-Related Symptoms of IBS-C

A poster titled Time to Relief of Key Abdominal and Bowel Symptoms of Irritable Bowel Syndrome with Constipation: A Post-Hoc Analysis of Randomized Controlled Trials of Linaclotide (P1431) will be presented by Darren M. Brenner, M.D., Northwestern University Feinberg School of Medicine, Chicago, IL, today, Oct. 25 from 10:30 a.m. to 4:15 p.m. PT. Data from the study suggested that >50% of patients with IBS-C treated with linaclotide will experience ≥30% decrease in the severity of abdominal pain and discomfort within three weeks and bloating within four weeks after initiating treatment. Median time to improved complete spontaneous bowel movements (CSBM) frequency preceded abdominal responses, although achievement of a “normal” CSBM frequency (≥3 CSBMs/week) lagged slightly behind abdominal pain and discomfort responses.

Another poster titled Linaclotide Improves Symptoms of Irritable Bowel Syndrome with Constipation, Irrespective of Severity and Age: A Post-Hoc Analysis of Pooled Trials (P2473) will be presented by Lin Chang, M.D., FACG, University of California, Los Angeles, on Tuesday, Oct. 26 from 10:30 a.m. to 4:00 p.m. PT. The poster reported (in a cohort of mostly females with IBS-C) baseline age-related differences in IBS-C abdominal symptom severity (discomfort and bloating; less so for pain). The study authors identified an intriguing peak symptom severity in the 50–59 age group which they note should be explored further, particularly given research linking symptom severity with hormonal changes. Importantly, linaclotide was effective across most age groups analyzed for decreasing abdominal symptoms, regardless of baseline symptom severity.

GI Disease Prevalence and Burden

A poster titled Examining the Impact of the COVID-19 Pandemic on the Prevalence of Rome IV Functional Gastrointestinal Disorders (P0385, Presidential Poster Award) was presented by Christopher V. Almario, M.D., MSHPM, FACG, Cedars-Sinai Medical Center, Los Angeles, CA on Sunday, Oct. 24. The poster reported that the prevalence of IBS, functional dyspepsia, and functional diarrhea increased significantly when compared to pre-COVID-19 estimates. The results were based on an initial online survey from May 3 – June 24, 2020 during the peak of the initial COVID-19 wave in the U.S. followed by monthly surveys starting in March 2021 (latter stages of the pandemic).

A poster titled Disease Burden and Care-Seeking Behavior for CIC Patients in the United States in the Era of COVID-19 (P1434), will be presented by Douglas CA Taylor, MBA, Ironwood Pharmaceuticals today, Oct. 25 from 10:30 a.m. to 4:15 p.m. PT. The study concluded that there remains a considerable disease burden and unmet need for patients with CIC who suffer from multiple bothersome symptoms. Surveyed patients with CIC reported significantly lower healthcare-related quality of life (HRQoL) versus controls. Reported health problem impact on work productivity during the past seven days was significantly higher among patients with CIC versus controls. Many patients reported worsening of CIC symptoms and canceling health care appointments due to the COVID-19 pandemic. The findings were based on a cross-sectional, on-line, general health survey of 16,325 people conducted from August 2020 to March 2021. Of the survey participants, 1,282 self-identified and met ROME IV for CIC.

On Tuesday, Oct. 26 during a simultaneous plenary session being held from 2:15– 3:45 p.m., Janice E. Oh, MD, MSc, Cedars-Sinai Medical Center will present findings from Abdominal Bloating in the U.S.: Results of a National Survey of 88,969 Americans Examining Prevalence, Burden of Illness, and Healthcare Seeking (oral presentation, S491). The survey found that nearly 1 in 7 adults in the U.S. experience bloating in the past week. Yet almost 60% of respondents with bloating never sought care, and 29% of those who never sought care either managed symptoms themselves or felt uncomfortable discussing with providers.

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. In the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS for the treatment of adults with IBS-C or CIC. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood's partner Astellas markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or chronic constipation. In China, (including Hong Kong and Macau) Ironwood’s partner Astra Zeneca markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C. Ironwood is also partnered with AbbVie for development and commercialization of linaclotide in all other territories worldwide. LINZESS® and CONSTELLA® are registered trademarks of 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 a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Under the guidance of our seasoned industry leaders, we continue to build upon our history of GI innovation and challenge what has been done before to shape what the future holds. We keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.

Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts.

We routinely post information that may be important to investors on our website at www.ironwoodpharma.com. In addition, follow us on Twitter and on LinkedIn.

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 the prevalence and burden among patients with GI conditions, and the research presented at ACG that could arm physicians with additional tools to navigate conversations with their adult IBS-C and CIC patients about their symptoms and treatment. These forward-looking statements 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 a statement. Applicable risks and uncertainties include those related to the effectiveness of development and commercialization efforts by us and our partners; preclinical and clinical development, manufacturing and formulation development of linaclotide; the risk that 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; the risk that findings from our completed nonclinical and clinical studies may not be replicated in later studies; the risk that we or our partners are unable to obtain, maintain or manufacture sufficient LINZESS or our product candidates, or otherwise experience difficulties with respect to supply or manufacturing; the 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 we may never get additional patent protection for linaclotide and other product candidates; 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; outcomes in legal proceedings to protect or enforce the patents relating to our products and product candidates, including abbreviated new drug application litigation; 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; the impact of the COVID-19 pandemic; and the risks listed under the heading "Risk Factors" and elsewhere in Ironwood's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, and in our subsequent SEC filings.

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Media:

Beth Calitri, 978-417-2031

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Investors:

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Source: Ironwood Pharmaceuticals, Inc.