Synergy Pharma’s irritable bowel drug succeeds in key study
Synergy Pharmaceuticals Inc said its experimental once-daily tablet, plecanatide, met the main goal of a late-stage study on irritable bowel syndrome patients with constipation (IBS-C), according to an analysis of preliminary data.
The New York-based company’s shares jumped about 16.7 percent to $6.47 before the bell on Friday.
The two doses being tested outperformed a placebo in patients who were overall responders.
Overall responders are patients whose abdominal pain was reduced by 30 percent or more and whose spontaneous bowel movements increased at least once in the same week, for at least half of the 12 treatment weeks, Synergy Pharma said.
The most common side effect across the 1,135 adult patients in the trial was diarrhea. Data on a second late-stage IBS-C study is expected to come later this month.
The U.S. Food and Drug Administration is reviewing plecanatide for the treatment of chronic idiopathic constipation, and is expected to reveal its decision by Jan. 29.
The company plans to submit an application to market the drug for IBS-C patients in 2017, it said on Friday.
Plecanatide, which consists of 16 amino acids, is designed to stimulate fluid secretion and promote stool consistency.
Irritable bowel syndrome is a chronic condition and has three forms: constipation (IBS-C), diarrhea (IBS-D), or mixed (IBS-M).
About 4-5 percent of American adults suffer from IBS-C, though this number may vary as patients often fluctuate between the three subtypes.
(Reporting by Natalie Grover in Bengaluru; Editing by Savio D’Souza)
Source: Reuters Health