Synergy announced additional clinical data from two Phase 3 trials, Study-00 and Study-03, evaluating the efficacy and safety of plecanatide for the treatment of chronic idiopathic constipation (CIC). Study findings were presented at Digestive Disease Week (DDW) in San Diego.
The company previously announced that plecanatide 3mg and 6mg doses met the primary endpoint in both Study-00 and Study-03 trials, which was the durable overall complete spontaneous bowel movement (CSBM) responder endpoint as defined by the FDA. Both doses demonstrated statistical significance in the proportion of patients who were durable overall CSBM responders vs. placebo for 12 weeks (Study-00: 21% in 3mg and 19.5% in 6mg groups vs. 10.2% in placebo, P<0.001 for both doses; Study-03: 20.1% in 3mg and 20% in 6mg groups vs. 12.8% in placebo, P=0.004 for both doses).
Additional data from Study-00 for plecanatide included significant improvement in the durable overall CSBM responder rates relative to placebo, noted improvements from baseline in CSBM and SBM frequency as early as week 1 and lasting through end of treatment, significant improvement in abdominal bloating scores from baseline for 12 weeks vs. placebo, and absence of bowel and abdominal symptom worsening from baseline.
In addition, both trials also demonstrated positive data on their secondary endpoints, showing that treatment with plecanatide was associated with statistically significant improvement in stool consistency throughout the treatment period (mean BSFS = 4). Patients in both studies also reported statistically significant improvement in constipation severity scores from baseline and higher satisfaction scores compared to placebo.
Synergy recently filed its first New Drug Application (NDA) for plecanatide in CIC. If approved by the FDA, the company intends to launch plecanatide with the CIC indication in the first quarter of 2017.
Plecanatide is a 16-amino acid peptide structurally similar to uroguanylin, a naturally occurring human GI peptide that works locally in the upper GI tract to stimulate digestive fluid movement and support regular bowel function.
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