Clinical Data

• A Phase III Study of the Efficacy and Safety of Plecanatide in the Treatment of Chronic Idiopathic Constipation (Study-00)
• Daily treatment with plecanatide significantly improved durable overall CSBM responder rates relative to placebo.
• Improvements from baseline in CSBM and SBM frequency were noted as early as week 1 and lasted through end of treatment.
• Significantly more patients in plecanatide groups had CSBMs and SBMs within 24 hours of the first dose of study medication.
• Abdominal bloating scores improved significantly from baseline over the 12-week treatment period for each dose of plecanatide relative to placebo.
• No worsening of bowel symptoms (including CSBM and SBM frequency) and abdominal symptoms relative to baseline was observed during post-treatment follow-up.
• Most adverse events (AEs) were mild or moderate in severity. Rates of discontinuation due to AEs were 5.1% in 3 mg and 5.3% in 6 mg dose groups compared to 1.3% in the placebo groups; discontinuations due to diarrhea were 2.7% in 3 mg and 2.6% in 6 mg dose groups compared to 0.4% in the placebo group.
• Serious AEs were experienced by less than 1.0% of patients.

Effect of Plecanatide on Stool Consistency in the Treatment of Chronic Idiopathic Constipation (CIC): Results from Two Phase 3 Studies

• In both phase 3 studies (Study-00, 1346 patients; Study-03, 1337 patients), plecanatide treatment showed statistically significant improvement from baseline in Bristol Stool Form Scale (BSFS) scores compared to placebo, bringing mean stool consistency scores to a normal physiological value (BSFS = 4).
• Improvements in stool consistency began in week 1 and lasted throughout the treatment period.

Effect of Plecanatide on Patient Assessments in Chronic Idiopathic Constipation (CIC): Results from Two Phase 3 Studies

• Plecanatide-treated patients reported statistically significant improvement in constipation severity scores from baseline compared to placebo that was sustained throughout the 12-week treatment period.
• Treatment with plecanatide also led to significant improvements in patient treatment satisfaction scores compared to placebo that were sustained throughout the 12-week treatment period.
• Plecanatide-treated patients showed a statistically significant desire for further therapy relative to placebo at the end of the study.