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Synergy has announced results from the first two pivotal Phase 3 trials evaluating plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
Plecanatide is a peptide made up of 16 amino acids and, with the exception of a single amino acid substitution, it is identical to uroguanylin. It is designed to replicate the function of uroguanylin, a naturally occurring and endogenous human GI peptide, which stimulates fluid secretion and promotes stool consistency.
The trial lasted 12 weeks and investigated 3mg and 6mg of plecanatide vs placebo. The primary endpoint for both doses was the percentage of patients who were Overall Responders (%), defined by the Food and Drug Administration (FDA) as a patient who fulfills both ≥30% reduction in worst abdominal pain and an increase of ≥1 complete spontaneous bowel movement (CSBM) from baseline.
Both plecanatide doses showed significant Overall Responder rates compared to placebo; 21.5% in 3mg and 24.0% in 6mg dose groups compared to 14.2% in placebo; P=0.009 for 3mg and P<0.001 for 6mg.
Diarrhea was the most common adverse event occurring in 3.2% of patients in the 3mg group and 3.7% of patients in the 6mg group, compared to 1.3% in the placebo group.
Plecanatide is currently under review by the FDA for the treatment of chronic idiopathic constipation (CIC) with a Prescription Drug User Fee Act (PDUFA) target action date of January 29, 2017. Pending on approval for CIC, the company plans to file a New Drug Application Supplement for plecanatide in IBS-C in Q1 2017.
For more information visit Synergypharma.com.
