Synergy Pharmaceuticals announced that plecanatide, its investigational oral drug for the treatment of chronic idiopathic constipation (CIC), was well tolerated and met the primary and key secondary endpoints of a Phase 2b/3 clinical study. Plecanatide is a synthetic analog of uroguanylin, a natriuretic hormone that regulates ion and fluid transport in the GI tract.
The randomized, double-blind, placebo-controlled, repeat-dose, dose-ranging study was designed to determine whether plecanatide could increase the number of complete spontaneous bowel movements (CSBM’s) and impact other parameters such as stool consistency, straining and time to first bowel movement in patients with CIC. The 12-week study, which included 951 CIC patients, evaluated 3 doses of plecanatide (0.3mg, 1mg, 3mg) plus a placebo arm.
Evidence of increasing efficacy was seen at increasing dose levels. The 3mg dose demonstrated a 19% (P=0.009) overall responder rate (vs. placebo of 10.7%), as well as demonstrated a mean increase in CSBMs over the 12-week treatment period of 2.13 (P<0.001). In addition, statistically significant improvements were seen in key secondary endpoints. The incidence of diarrhea at 3mg was observed to be 9.7% (vs. placebo incidence of 1.3%).
For more information call (212) 297-0020 or visit www.synergypharma.com.