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 <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.ironwoodpharma.com%2F&amp;esheet=51592251&amp;newsitemid=20170720005395&amp;lan=en-US&amp;anchor=Ironwood+Pharmaceuticals%2C+Inc.&amp;index=1&amp;md5=ca91831f30f34cf94e9ff1a61a5f4e29" rel="nofollow" rel="nofollow">Ironwood 
 Pharmaceuticals, Inc.</a> IRWD, a commercial biotechnology 
 company, announced positive top-line data from a Phase IIb clinical 
 trial evaluating IW-3718 in adult patients with uncontrolled 
 gastroesophageal reflux disease (GERD). The trial met its primary 
 endpoint, indicating that twice-daily, oral dosing of IW-3718 1500 mg 
 plus a proton pump inhibitor (PPI) significantly reduced heartburn 
 severity in patients with uncontrolled GERD compared to patients treated 
 with a PPI alone. Further, more than half of patients treated with 
 IW-3718 1500 mg plus a PPI achieved a clinically meaningful reduction in 
 heartburn severity. IW-3718 1500 mg was well tolerated in the trial. 
 Ironwood plans to have end of Phase II meetings with the U.S. Food and 
 Drug Administration (FDA), after which the company expects to advance 
 IW-3718 1500 mg into Phase III development in the second half of 2018.
 
 
 Uncontrolled GERD is a chronic condition affecting an estimated 10 
 million Americans who continue to suffer from symptoms such as heartburn 
 and regurgitation despite receiving treatment with PPIs – the current 
 standard of care – to suppress acid produced in the stomach. Ironwood's 
 clinical research has demonstrated that reflux of bile from the 
 intestine into the stomach and esophagus plays a key role in the ongoing 
 symptoms of uncontrolled GERD. IW-3718 is a novel formulation of a bile 
 acid sequestrant designed to release in the stomach over an extended 
 period of time, bind to bile that refluxes into the stomach, and 
 potentially provide symptomatic relief in uncontrolled GERD.
 
 
 "Millions of patients with GERD globally are significantly impacted by 
 frequent and bothersome heartburn and regurgitation symptoms despite 
 diligently taking their PPIs. They are seeking relief, asking for new 
 treatment options and we really have nothing to offer them," said 
 Michael Vaezi, M.D., Ph.D., professor of medicine, division of 
 gastroenterology and hepatology, director of the Center for Swallowing 
 and Esophageal Disorders at Vanderbilt University Medical Center and an 
 investigator for the study. "The data from this trial are encouraging, 
 as they provide strong evidence that bile plays a key role in 
 uncontrolled GERD and that IW-3718 may bring a much-needed new approach 
 to treating these patients."
 
 
 Data from the Phase IIb trial showed a dose response across the primary 
 and key secondary endpoints, with the most pronounced response observed 
 at the highest dose of IW-3718 studied (1500 mg). Top-line data were as 
 follows:
 
 <ul xmlns="http://www.w3.org/1999/xhtml">
 <li xmlns="http://www.w3.org/1999/xhtml" class="bwlistitemmargb">
 Percent Change from Baseline to Week 8 in Weekly Heartburn Severity 
 (primary endpoint): patients treated with IW-3718 1500 mg plus a 
 PPI showed a mean decrease of 58.0% from baseline in heartburn 
 severity compared to 46.0% in patients treated with a PPI alone (p = 
 0.04).
 </li>
 <li xmlns="http://www.w3.org/1999/xhtml" class="bwlistitemmargb">
 Clinically Meaningful Degree of Improvement in Weekly Heartburn 
 Severity: a 45% reduction in weekly heartburn severity was 
 determined to be clinically meaningful for patients in this study 
 based on patient-reported outcome measures.
 </li>
 <li xmlns="http://www.w3.org/1999/xhtml" class="bwlistitemmargb">
 Heartburn Responder: a heartburn responder was defined as a 
 patient who experienced at least a 45% reduction from baseline in 
 heartburn severity for at least four out of eight weeks, including at 
 least one of the last two weeks. 52.9% of patients treated with 
 IW-3718 1500 mg plus a PPI were heartburn responders, compared to 
 37.1% of patients treated with a PPI alone.
 </li>
 <li xmlns="http://www.w3.org/1999/xhtml" class="bwlistitemmargb">
 Percent Change from Baseline to Week 8 in Weekly Regurgitation 
 Frequency: patients treated with IW-3718 1500 mg plus a PPI showed 
 a mean decrease of 55.4% from baseline in regurgitation frequency 
 compared to 37.9% in patients treated with a PPI alone (among patients 
 with baseline regurgitation; p = 0.01).
 </li>
 </ul>
 
 There were no treatment-related serious adverse events reported with 
 IW-3718 1500 mg. The most common adverse event reported overall was 
 constipation, which was reported in 7.4% of patients on IW-3718 1500 mg 
 plus a PPI (n=5) compared to 7.1% of patients on a PPI alone (n=5). All 
 constipation adverse events reported were mild or moderate in severity. 
 Discontinuation rates due to adverse events were less than 5% and 
 similar across treatment groups.
 
 
 "The results from this trial, demonstrating encouraging improvements in 
 heartburn severity and regurgitation, appear to validate our approach of 
 targeting bile acid reflux in patients with uncontrolled GERD in 
 addition to suppressing acid with PPIs," said Mark Currie, Ph.D., senior 
 vice president, chief scientific officer, and president of research and 
 development at Ironwood. "These data were consistent and robust across 
 key endpoints, and reinforce our belief that IW-3718 may lead to 
 meaningful symptom relief for patients with uncontrolled GERD."
 
 
 Ironwood intends to present additional data from the Phase IIb clinical 
 trial at an upcoming scientific meeting and/or via peer-reviewed 
 publications.
 
 
 IW-3718 is wholly-owned by Ironwood. Ironwood has existing patents and 
 pending patent applications for IW-3718 that are expected to provide 
 patent coverage into the mid-2030s.
 
 
 Conference Call Information
 
 
 Ironwood will host a conference call and webcast at 8:30 a.m. Eastern 
 Time on Thursday, July 20, 2017, to discuss the top-line results of the 
 IW-3718 Phase IIb clinical trial. Individuals interested in 
 participating in the call should dial (877) 643-7155 (U.S. and 
 Canada) or (914) 495-8552 (international) using conference ID number 
 58702323. To access the webcast, please visit the Investors section of 
 Ironwood's website at <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.ironwoodpharma.com&amp;esheet=51592251&amp;newsitemid=20170720005395&amp;lan=en-US&amp;anchor=www.ironwoodpharma.com&amp;index=2&amp;md5=391385904a6f037f23557e8b85083792" rel="nofollow" rel="nofollow">www.ironwoodpharma.com</a> 
 at least 15 minutes prior to the start of the call to ensure adequate 
 time for any software downloads that may be required. The call will be 
 available for replay via telephone starting at approximately 11:30 a.m. 
 Eastern Time, on July 20, 2017 running through 11:59 p.m. Eastern Time 
 on July 27, 2017. To listen to the replay, dial (855) 859-2056 (U.S. and 
 Canada) or (404) 537-3406 (international) using conference ID number 
 58702323. The archived webcast will be available on Ironwood's website 
 for 14 days beginning approximately one hour after the call has 
 completed.
 
 
 Phase IIb Trial Design
 
 
 The randomized, double-blind, placebo-controlled Phase IIb clinical 
 trial enrolled 282 adult patients with GERD (including 276 adult 
 patients with baseline regurgitation), confirmed by endoscopy, who were 
 taking a PPI and continuing to experience GERD symptoms, including 
 heartburn and regurgitation, at least four days per week during the 
 previous eight weeks. The trial included a two-week pretreatment period, 
 during which baseline symptoms were assessed via an electronic diary. 
 Patients were then randomly assigned to receive either placebo or one of 
 three doses of IW-3718 (500 mg, 1,000 mg or 1,500 mg) twice daily for 
 eight weeks, in addition to their daily PPI therapy. The primary 
 efficacy endpoint was percent change in weekly heartburn severity from 
 baseline to week 8. Additionally, a heartburn responder endpoint was 
 defined based on a clinically meaningful degree of improvement derived 
 for the uncontrolled GERD population from patient reported outcome 
 measures collected in the study. No adjustments were made for 
 multiplicity; p-values were reported as nominal.
 
 
 About IW-3718
 
 
 IW-3718 is a novel, gastric retentive formulation of a bile acid 
 sequestrant, developed by Ironwood using the proprietary Acuform® drug 
 delivery formulation technology licensed from Depomed, Inc. IW-3718 is 
 designed to deliver the bile acid sequestrant to the stomach over an 
 extended period of time where it is positioned to intercept bile before 
 it reaches the esophagus. Data from non-clinical and clinical studies 
 collectively support the extended release and gastric-retentive profile 
 of IW-3718. Ironwood has existing patents and pending patent 
 applications for IW-3718 that are expected to provide patent coverage 
 into the mid-2030s.
 
 
 About Uncontrolled Gastroesophageal Reflux Disease (GERD)
 
 
 An estimated 10 million adult Americans and more than 60 million adult 
 patients globally suffer from uncontrolled gastroesophageal reflux 
 disease (GERD), meaning they continue to experience symptoms such as 
 heartburn and regurgitation despite receiving treatment with a proton 
 pump inhibitor (PPI). While PPIs suppress production of stomach acid, 
 Ironwood's clinical research demonstrates that reflux of bile from the 
 intestine into the stomach and esophagus plays a key role in the ongoing 
 symptoms of uncontrolled GERD. FDA-approved treatment options for these 
 patients are limited.
 
 
 About Ironwood Pharmaceuticals
 
 
 Ironwood Pharmaceuticals IRWD is a commercial biotechnology 
 company focused on creating medicines that make a difference for 
 patients, building value for our fellow shareholders, and empowering our 
 passionate team. We are commercializing two innovative primary care 
 products: linaclotide, the U.S. branded prescription market leader for 
 adults with irritable bowel syndrome with constipation (IBS-C) or 
 chronic idiopathic constipation (CIC), and lesinurad, which is approved 
 to be taken with a xanthine oxidase inhibitor (XOI) for the treatment of 
 hyperuricemia associated with uncontrolled gout. We are also advancing a 
 pipeline of internally and externally generated innovative product 
 candidates in areas of significant unmet need, including uncontrolled 
 gastroesophageal reflux disease and vascular and fibrotic diseases. 
 Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. 
 For more information, please visit <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.ironwoodpharma.com&amp;esheet=51592251&amp;newsitemid=20170720005395&amp;lan=en-US&amp;anchor=www.ironwoodpharma.com&amp;index=3&amp;md5=7a7f2fceaeab5d15327dfd7c560c07f6" rel="nofollow" rel="nofollow">www.ironwoodpharma.com</a> 
 or <a xmlns="http://www.w3.org/1999/xhtml" href="http://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.twitter.com%2Fironwoodpharma&amp;esheet=51592251&amp;newsitemid=20170720005395&amp;lan=en-US&amp;anchor=www.twitter.com%2Fironwoodpharma&amp;index=4&amp;md5=9b514979c5e43700a4527693e26eeefa" rel="nofollow" rel="nofollow">www.twitter.com/ironwoodpharma</a>; 
 information that may be important to investors will be routinely posted 
 in both these locations.
 
 
 ACUFORM® is a registered trademark of Depomed, Inc.
 
 
 This press release contains forward-looking statements. Investors are 
 cautioned not to place undue reliance on these forward-looking 
 statements, including statements about the topline assessment of the 
 data from the Phase IIb clinical trial of IW-3718; the development, 
 regulatory and commercialization plans for IW-3718, and the timing 
 thereof, including further investigation and advancement of IW-3718, 
 engaging with the FDA, advancing IW-3718 into Phase III development and 
 commercializing IW-3718 within and outside the U.S.; the design of the 
 Phase IIb trial and its impact on the results thereof, as well as the 
 results and their validation of our approach to targeting bile acid 
 reflux in patients with uncontrolled GERD and expectations relating to 
 replication in Phase III; the timing of presentation of additional 
 IW-3718 Phase IIb data; the design, potential indications for, and 
 possible benefits of IW-3718 and its potential as a treatment for 
 patients with uncontrolled GERD; the potential for patient adherence to 
 IW-3718; the level of competition in the uncontrolled GERD space; 
 physicians' willingness to adopt and the potential for broad payer 
 access and reimbursement; prevalence and unmet need; market size, growth 
 and opportunity, including peak sales and potential demand for IW-3718 
 in the U.S.; and the strength of the intellectual property protection 
 for IW-3718. 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 preclinical and clinical 
 development, manufacturing and formulation development; the risk that 
 future clinical studies need to be discontinued for any reason, 
 including safety, tolerability, enrollment, manufacturing or economic 
 reasons; the risk that findings from our completed nonclinical and 
 clinical studies may not be replicated in later studies; efficacy, 
 safety and tolerability of IW-3718; the risk that the therapeutic 
 opportunities for IW-3718 are not as we expect; decisions by regulatory 
 authorities; those risks related to competition and future business 
 decisions made by us and our competitors or potential competitors; the 
 risk that we may never get sufficient patent protection for IW-3718 or 
 that we are not able to successfully protect such patents; developments 
 in the intellectual property landscape; and the risks listed under the 
 heading &#34;Risk Factors&#34; and elsewhere in Ironwood&#39;s Quarterly Report on 
 Form 10-Q for the quarter ended March 31, 2017, and in our 
 subsequent SEC filings. 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.
 
 
 
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Ironwood Pharmaceuticals Reports Positive Top-line Results from IW-3718 Phase IIb Trial in Uncontrolled Gastroesophageal Reflux Disease - Ironwood Pharmaceuticals (NASDAQ:IRWD)

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