Additional phase III data presented for plecanatide in chronic idiopathic constipation- Synergy Pharmaceuticals

Synergy Pharmaceuticals announced additional data from two pivotal phase III clinical trials (Study-00 and Study-03) evaluating the efficacy and safety of plecanatide, a once-daily oral tablet, in treating patients with chronic idiopathic constipation (CIC). The primary endpoint for both pivotal trials was the durable overall complete spontaneous bowel movement (CSBM) responder endpoint, as defined by the FDA.

As previously disclosed, both plecanatide 3 mg and 6 mg doses met the primary endpoint and demonstrated statistical significance in the proportion of patients in the intention-to-treat population who were durable overall CSBM responders compared to placebo during the 12-week treatment period.

Results also show that daily treatment with plecanatide significantly improved durable overall CSBM responder rates relative to placebo. Improvements from baseline in CSBM and SBM frequency were noted as early as week 1 and lasted through end of treatment. Significantly more patients in plecanatide groups had CSBMs and SBMs within 24 hours of the first dose of study medication. Abdominal bloating scores improved significantly from baseline over the 12-week treatment period for each dose of plecanatide relative to placebo. In both studies (Study-00, 1346 patients; Study-03, 1337 patients), plecanatide treatment also showed statistically significant improvement from baseline in Bristol Stool Form Scale (BSFS) scores compared to placebo, bringing mean stool consistency scores to a normal physiological value (BSFS = 4). Improvements in stool consistency began in week 1 and lasted throughout the treatment period. Plecanatide-treated patients reported statistically significant improvement in constipation severity scores from baseline compared to placebo that was sustained throughout the 12-week treatment period. Treatment with plecanatide also led to significant improvements in patient treatment satisfaction scores compared to placebo that were sustained throughout the 12-week treatment period. Serious AEs were experienced by less than 1.0% of patients. Data were presented at Digestive Disease Week.

Comment: plecanatide is currently filed with the FDA for chronic idiopathic constipation, with a Prescription Drug User Fee Act (PDUFA) target action date is January 29, 2017.