Linaclotide: Phase III data
Top-line data from the double-blind, North American Phase III MCP-103-302 trial in 805 patients showed that once-daily 266 µg oral linaclotide met all co-primary and secondary endpoints vs. placebo. In May, Ironwood said it planned to conduct separate analyses of its ongoing North American Phase III trials for the European Medicines Agency (EMA) and FDA using different primary endpoints. At that time, EMA indicated that it would allow the company to use its ongoing North American Phase III trials to support an MAA for linaclotide (see BioCentury, May 17).
For the FDA analysis, linaclotide met the 4 co-primary endpoints of a significantly greater proportion of patients with a >=30% reduction in abdominal pain, >=3 CSBMs and an increase of >=1 CSBM in the same week for >=9 of 12 weeks vs. placebo (12.7% vs. 3%, p<0.0001); a significantly greater proportion of patients achieving >=3 CSBMs and an increase of >=1 CSBM in the same week for >=9 of 12 weeks vs. placebo (18% vs. 5%, p<0.0001); a significantly greater proportion of patients experiencing a >=30% reduction in abdominal pain for >=9 of 12 weeks vs. placebo (38.9% vs. 19.6%, p<0.0001); and a significantly greater proportion of patients experiencing a >=30% reduction in abdominal pain and an increase of >=1 CSBMs in the same week for >=6 of 12 weeks vs. placebo (33.7% vs. 13.9%, p<0.0001). ...