Shares of Synergy Pharmaceuticals have surged more than 17%, putting them on track for a 52-week high, after it reported that top-line results from a clinical trial evaluating plecanatide to treat irritable bowel syndrome with constipation (IBS-C) has met the study’s primary endpoint. The stock hit a pre-market high of $6.97, above its prior high of $6.16.
Preliminary analysis of the data indicates that both plecanatide 3 mg and 6 mg doses met the study’s primary endpoint and showed statistical significance in the percentage of patients who were overall responders compared to placebo. An overall responder, as defined by the FDA, is a patient who fulfills both a reduction in worst abdominal pain of 30% or more, and an increase of one or more complete spontaneous bowel movement, in the same week, for at least 50% of the 12 treatment weeks.
“These data reinforce our strong belief that plecanatide may represent an important new treatment option for the millions of patients currently suffering from IBS-C,” said Gary Jacob, CEO of Synergy Pharmaceuticals Inc.