Synergy Pharmaceuticals Submits Supplemental New Drug Application (sNDA) for TRULANCE™ (Plecanatide) for the Treatment of Adults with Irritable Bowel Syndrome with Constipation (IBS-C)

NEW YORK, NY, USA I March 27, 2017 I Synergy Pharmaceuticals Inc. (NASDAQ:SGYP) announced today that the company has submitted a supplemental New Drug Application (sNDA) for TRULANCE™ (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).

On January 19, 2017, TRULANCE was approved in the United States for the treatment of adults with chronic idiopathic constipation (CIC) and is now available in U.S. pharmacies. The recommended dosage of TRULANCE is 3 mg taken orally, once daily, with or without food at any time of the day.

“Following the successful launch of TRULANCE in CIC, the submission of this supplemental application marks another important milestone for Synergy in our ongoing quest to bring new treatments that address significant unmet medical needs to patients living with GI disorders,” said Gary S. Jacob, Ph.D., Chairman and CEO, Synergy Pharmaceuticals Inc. “We are sincerely grateful to the patients and researchers in these studies as well as our clinical and regulatory teams for their tireless efforts in bringing us one step closer to providing a new treatment for this condition. If approved, we believe TRULANCE will provide an additional, much-needed, new treatment option for people with IBS-C.”

The application is based on data from two randomized, 12-week, double-blind, placebo-controlled Phase 3 studies evaluating the efficacy and safety of TRULANCE for the treatment of adults with IBS-C. Across the two trials, more than 2,100 patients received a once-daily tablet of TRULANCE (3 mg or 6 mg doses) or placebo.

Synergy announced positive results from the two Phase 3 trials of TRULANCE in adults with IBS-C in December 2016. In both trials, TRULANCE 3 mg and 6 mg doses met the primary endpoint showing statistical significance in the percentage of patients who were Overall Responders compared to placebo during the 12-week treatment period. (Study 1: 21.5% in 3 mg and 24.0% in 6 mg dose groups compared to 14.2% in placebo; p=0.009 for 3 mg and p<0.001 for 6 mg; Study 2: 30.2% in 3 mg and 29.5% in 6 mg dose groups compared to 17.8% in placebo; p<0.001 for 3 mg and p<0.001 for 6 mg). An Overall Responder, as currently defined by the U.S. Food and Drug Administration (FDA), is a patient who fulfills both ≥ 30% reduction in worst abdominal pain and an increase of ≥ 1 complete spontaneous bowel movement (CSBM) from baseline, in the same week, for at least 50% of the 12 treatment weeks. This is the current primary endpoint required for FDA approval in IBS-C.

In both studies, the most common adverse event was diarrhea (Study 1 = 3.2% at 3 mg and 3.7% at 6 mg compared to 1.3% at placebo; Study 2 = 5.4% at 3 mg and 4.3% at 6 mg compared to 0.6% at placebo).

The company plans to present additional Phase 3 data from the two IBS-C trials at upcoming scientific meetings later this year.

Indications and Usage

TRULANCE is a guanylate cyclase-C (GC-C) agonist indicated in adults for the treatment of chronic idiopathic constipation (CIC).

About TRULANCE

TRULANCE (plecanatide) is a once-daily tablet approved for adults with CIC and is being evaluated for IBS-C. With the exception of a single amino acid substitution for greater binding affinity, TRULANCE is structurally identical to uroguanylin, a naturally occurring and endogenous human GI peptide. Uroguanylin activates GC-C receptors in a pH-sensitive manner primarily in the small intestine, stimulating fluid secretion and maintaining stool consistency necessary for regular bowel function.

About Irritable Bowel Syndrome with Constipation (IBS-C)

Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by recurrent abdominal pain and associated with two or more of the following: related to defecation, associated with a change in the frequency of stool, or associated with a change in the form (appearance) of the stool. IBS can be subtyped by the predominant stool form: constipation (IBS-C), diarrhea (IBS-D) or mixed (IBS-M). Those within the IBS-C subtype experience hard or lumpy stools more than 25 percent of the time they defecate, and loose or watery stools less than 25 percent of the time. It is estimated that the prevalence of IBS-C in the U.S. adult population is approximately 4 to 5 percent, although this number can vary as patients may fluctuate between the three subtypes of IBS.

About Synergy Pharmaceuticals

Synergy is a biopharmaceutical company focused on the development and commercialization of novel GI therapies. The company has pioneered discovery, research and development efforts on analogs of uroguanylin, a naturally occurring and endogenous human GI peptide, for the treatment of GI diseases and disorders. Synergy’s proprietary uroguanylin analog platform includes one commercial product TRULANCE and a second lead product candidate, dolcanatide. For more information, please visit www.synergypharma.com.

SOURCE: Synergy Pharmaceuticals

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