Synergy Pharmaceuticals (SGYP) Stock Soars after Positive Results for Plecanatide
Shares of Synergy Pharmaceuticals Inc. (SGYP) were trading up +1.74 or +21.19 percent to $9.95 per share in Thursday's premarket after the company announced positive results in the second Phase 3 trial of its gastrointestinal drug plecanatide in patients suffering from Chronic Idiopathic Constipation or CIC. Synergy Pharmaceutical stock closed at $8.21 per share, down -0.03 or -0.39 percent in Wednesday's regular trading session.
New York, New York based Synergy Pharmaceuticals Inc. is a biopharmaceutical company focusing on the development of new therapies to treat gastrointestinal disease and disorders based on uroguanylin, a natural human hormone.
Synergy reported this morning that it had obtained positive results in the second of two pivotal Phase 3 clinical trials to evaluate the safety and efficacy of plecanatide in two different treatment doses: 3.0 mg and 6.0 mg. The studies were conducted on 1,337 adult patients (21.6 percent males and 78.4 percent females) suffering from chronic idiopathic constipation or CIC, which were given a tablet once a day.
Analysis of the preliminary data indicated that both the 3.0 mg and 6.0 mg doses of plecanatide met the primary endpoint of the study. The study demonstrated a significant statistical difference in the proportion of patients in the intention to treat population that were durable overall responders compared to patients given a placebo.
Gary S. Jacob, Ph.D., Chairman and Chief Executive Officer of Synergy said in a press release that, "We are thrilled with the positive results of this trial, we now have successfully completed the two largest phase 3 trials ever conducted in CIC and plecanatide's treatment effect and tolerability profile have been remarkably consistent. We look forward to filing our first NDA with plecanatide in the CIC indication and the opportunity to bring this novel treatment to market.
The first phase 3 CIC trial, which also obtained positive results was conducted in North America on 1,346 adult patients randomly assigned to take 3.0 mg, 6.0 mg or a placebo once a day for a 12-week period. The primary endpoint required for approval in the United States was met by both studies.
The results of the most recent 12-week studies showed a positive response in 20.1 percent of patients taking the 3.0 mg dose and 20.0 percent for the group given a 6.0 mg dose compared to 12.8 percent for the placebo group in both doses. The durable overall responder endpoint met current FDA endpoint requirements for approval in the United States for the treatment of CIC.
Synergy Pharmaceutical stock has almost tripled since trading under $3.50 per share in mid-May. The stock has sold off somewhat this morning and will open somewhere near its yearly high of $9.76.
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