Sucampo Pharmaceuticals presents Phase 2 cobiprostone clinical trial data at DDW 2010

Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP) today presented results of a phase 2 clinical trial of cobiprostone, an investigational drug, for the prevention of gastric ulcers and other gastrointestinal injuries in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs). These data were presented at the Digestive Disease Week (DDW) 2010 conference in New Orleans, Louisiana, as part of the distinguished abstract plenary session.

“We believe that cobiprostone has the potential to offer patients a means of preventing gastric injury associated with NSAID therapy. We look forward to continuing its clinical development and considering its potential in combination with other therapies.”

Byron Cryer, M.D., the principal investigator in the trial and the John C. Vanatta III Professor of Medicine at the University of Texas Southwestern and North Texas VA Health Care System in Dallas, Texas, said, "These data demonstrate that cobiprostone may be a new strategy for prevention of gastrointestinal injury in patients receiving NSAIDs. If successfully developed for this indication, cobiprostone would protect a large number of patients."

Ryuji Ueno, M.D., Ph.D., Ph.D., Chairman and Chief Executive Officer of Sucampo Pharmaceuticals, Inc., said, "We believe that cobiprostone has the potential to offer patients a means of preventing gastric injury associated with NSAID therapy. We look forward to continuing its clinical development and considering its potential in combination with other therapies."

Results of the Trial

Highlights from the trial data were:

• Use of high-dose cobiprostone was associated with a 50% reduction in gastroduodenal ulcers when compared to placebo.
• Time to onset of all ulcer and erosion development was statistically significantly delayed in the cobiprostone groups across the 12-week treatment period.
• The mean treatment duration with naproxen was increased dose dependently with cobiprostone treatment at 18, 36, and 54 mcg vs. placebo (60.3, 62.1 and 71.1 days vs. 49.1 days, respectively).
• Use of high-dose cobiprostone was associated with the lowest percentage of patient discontinuations due to ulcer development.
• Cobiprostone was well tolerated and may have the potential to prevent clinically apparent gastrointestinal events with NSAID therapy.