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Synergy Pharma completes patient enrollment plecanatide Phase 3

  • All patients have been enrolled in the second of two pivotal Phase 3 studies assessing two doses (3 mg and 6 mg) of Synergy Pharmaceuticals (SGYP +1%) plecanatide in patients with chronic idiopathic constipation (CIC). This follows the completion of patient enrollment in the first Phase 3 trial on January 8.
  • The primary efficacy endpoint is the proportion of patients who are Overall Responders during the 12-week treatment period. An Overall Responder is one who has three or more complete spontaneous bowel movements ((CSBMs)) per week plus an increase of at least one CSBM from baseline in the same week for nine out of the twelve weeks, including at least three of the last four weeks. Plecanatide met this endpoint in an earlier Phase 2 trial.
  • The company expects top-line results from the first Phase 3 trial in Q2 and from the second Phase 3 in Q3. It plans to submit a New Drug Application (NDA) to the FDA for this indication in Q4.

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Synergy Pharmaceuticals, Inc.