Shares of Synergy Pharmaceuticals (SGYP) soared 67% today on positive phase 3 results for patients with Chronic Idiopathic Constipation -- CIC. These results stem from one of the current phase 3 trials with these CIC patients. The study recruited up to 1,346 who that took Synergy's drug plecanatide, one pill per day. Patients in the trial either took 3 mg plecanatide, 6 mg plecanatide, or a placebo compound.
What investors were most excited about is that both the 3 mg and 6 mg plecantide drug performed better than the placebo compound over a 12-week treatment period. The responses in the phase 3 clinical trial were as follows:
- 3 mg plecanatide - 21% response rate
- 6 mg plecanatide - 19.5% response rate
- placebo compound - 10.2% response rate
If we compared the response rate of both 3mg and 6 mg plecanatide treatment and compare it to the placebo compound both active drugs attain a p-value of p < 0.001. Any p-value under 0.01 means that the active drug was statistically significant over the placebo compound. In this case both drugs were better than the placebo compound, thus the high surge in today's share price.
Plecanatide was mostly safe, with only a small portion of patients, about 5%, reporting diarrhea. Synergy expects to read out its other phase 3 trial by Q3 of 2015 where further positive results would create another catalyst for the company's share price. Synergy plans to file a New Drug Application -- NDA -- to the FDA by Q4 2015 for approval of plecanatide in the CIC indication.



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