Top-Line Results for Plecanatide in Chronic Idiopathic Constipation Trial
Synergy Pharmaceuticals announced positive results from the first of two Phase 3 clinical trials evaluating the efficacy and safety of plecanatide 3mg and 6mg treatment doses in patients with chronic idiopathic constipation (CIC).
The first clinical trial in the Phase 3 CIC program is a randomized, 12-week, double-blind, placebo-controlled trials evaluating the efficacy and safety of plecanatide in 1,346 adults. Both trials include a two-week pre-treatment baseline period, a 12-week treatment period, and a two-week post-treatment period. Patients were randomly assigned to take 3mg or 6mg plecanatide or placebo once-a-day during the 12 week treatment period. The primary endpoint for both trials is the proportion of durable overall responders (%).
Preliminary analysis of the data indicates that both plecanatide 3mg and 6mg doses met the study's primary endpoint and demonstrated statistical significance in the proportion of patients in the intention-to-treat population who were durable overall responders compared to placebo during the 12-week treatment period (21.0% in 3mg and 19.5% in 6mg dose groups compared to 10.2% in placebo; P<0.001 for both doses).
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