- Synergy Pharmaceuticals (SGYP -1.4%) presents new long-term safety data of plecanatide, its investigational, orally-administered compound currently being evaluated by the FDA for the treatment of chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). These data, which were presented at the American College of Gastroenterology (ACG) annual scientific meeting, showed that plecanatide was associated with low adverse events and low discontinuation rates in patients with CIC who received plecanatide (3 mg or 6 mg) once-daily for up to 72 weeks.
- The most common adverse events in both dose groups in the 2,370-subject trial were diarrhea and urinary tract infection.
- Synergy also presented plecanatide data from an integrated efficacy and safety analysis which are consistent with findings of two previously presented double-blind, placebo-controlled Phase 3 trials that evaluated more than 2,600 patients with CIC over a 12-week treatment period. These additional analyses confirmed a significantly greater response rate of durable overall complete spontaneous bowel movements (CSBM), a primary endpoint defined by the FDA for regulatory approval in CIC in each of the two plecanatide dose groups (3 mg, 20.5%; 6 mg, 19.8%) when compared to the placebo group (11.5%, p<0.001 for both doses). Secondary endpoints (stool consistency, straining and bloating) were significantly improved compared to placebo.
- CIC affects 14% of the population in North America. People with CIC have persistent symptoms of difficult and infrequent bowel movements.
- Plecanatide is the first investigational therapy designed to replicate the activity of uroguanylin, a naturally occurring human gastrointestinal peptide, by working locally in the proximal small intestine to stimulate digestive fluid movement and support regular bowel function.