Ironwood Pharmaceuticals to Highlight IW-3718 and Linaclotide Data at Digestive Disease Week 2019

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today announced that the company and its collaborators will present clinical data for IW-3718, and both clinical and non-clinical data for linaclotide during Digestive Disease Week (DDW) being held in San Diego, CA, May 18 through May 21, 2019.

During an oral presentation, Michael Vaezi, M.D., Ph.D., of Vanderbilt University will share Phase IIb data on the effect of IW-3718 on a spectrum of symptoms associated with persistent gastroesophageal reflux disease (GERD) despite treatment with proton pump inhibitors (PPIs). Additional data will be presented in poster sessions highlighting the prevalence and significant burden of illness for patients living with persistent GERD, as well as the development and validation of a patient-reported outcome instrument to measure treatment benefit in clinical trials of persistent GERD.

IW-3718 is being evaluated in Phase III clinical trials for the treatment of persistent GERD, a condition affecting an estimated 10 million Americans who continue to suffer from heartburn and regurgitation despite receiving treatment with PPIs, the current standard of care. Bile acids, which are produced in the intestine and play an important role in the digestive process, have been implicated as contributors to GERD symptoms.^1,2

With regard to linaclotide, data will be featured in a poster of distinction which introduces a new patient-reported outcome (PRO) measure developed for the abdominal symptoms of IBS-C, called the Diary for Irritable Bowel Syndrome Symptoms—Constipation (DIBSS-C). The DIBSS-C is being used in an ongoing Phase IIIb study that is evaluating the efficacy and safety of linaclotide 290 mcg on multiple abdominal symptoms including pain, bloating and discomfort in adult patients with IBS-C.

In other poster sessions, researchers will present data on the expression of the GC-C receptor —the pharmacological target of linaclotide in IBS-C and CIC—in pediatric patients; real-world evidence on the use of opioids for pain management among patients with chronic gastrointestinal disorders including IBS; and preclinical data on the mechanisms of action of the effect of linaclotide on visceral pain in the GI tract and in related visceral organs.

The data will be presented as follows:

Phase II Data on Effect of IW-3718 on a Spectrum of GERD Symptoms in Patients with Persistent GERD (Oral Presentation)

• Impact of IW-3718, a Novel Gastric-Retentive Bile-Acid Sequestrant, on a Spectrum of GERD Symptoms in Patients with Persistent GERD Receiving PPIs – Results from a Double-Blind, Placebo-Controlled Study (oral presentation #12), by Michael Vaezi, M.D., Ph.D., Vanderbilt University Medical Center, Nashville, TN, et al. will be presented at the Advances in the Management of Gastroesophageal Reflux Disease session on Saturday, May 18, 8:45 a.m. to 9:00 a.m., in Room 7 of the San Diego Convention Center.

Patient Experience in GERD