E Synergy Pharmaceuticals Announces Positive Results For Second Phase 3 Trial

Shares of Synergy Pharmaceuticals (SGYP) are up about 5% today after the company reported positive phase 3 results in its second study of plecanatide for patients with Chronic Idiopathic Constipation — CIC. This phase 3 trial had recruited a total of 1,337 patients with CIC who were split into two different dosing groups. 

Plecanatide is Synergy's constipation drug that was being evaluated in this trial to determine if patients  responded to the treatment. One dosing group of patients took 3 mg of plecanatide and the other group took 6 mg of plecanatide, in each case measured against patients taking placebo. Patients taking either dose of plecanatide responded to the treatment and results were superior to placebo in the 12 week treatment period. (In each dosage group about 20% had positive durable response, vs. 8% to placebo.)

The only serious adverse event observed in the trial of plecanatide was diarrhea but only slightly higher than placebo, as shown below: 

  • plecanatide 3 mg  = 3.2 % of patients
  • plecanatide 6 mg = 4.5% of patients
  • placebo = 1.3% of patients
  • Considering that patients responded better overall with plecanatide compared to placebo, the slight percentage increase of patients experiencing diarrhea who took plecanatide shouldn't be a cause of concern. These patients with constipation need a better form of treatment option and plecanatide provides that opportunity. Now Synergy Pharmaceuticals is focused on filing an NDA for this drug compound to bring it to market for these patients with CIC. 

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