Budesonide MMX meets UC endpoint

Cosmo Pharmaceuticals S.p.A. (SIX:COPN) said once-daily 9 mg oral budesonide MMX met the primary endpoint of superiority to placebo in the Phase III CB-01-02/02 trial to treat ulcerative colitis (UC). Budesonide delivered using MMX multi-matrix system technology was superior in the proportion of patients achieving clinical remission as measured by Ulcerative Colitis Disease Activity Index (UCDAI) score at week eight (17.4% vs. 4.5%, p=0.0047). The once-daily 6 mg dose of budesonide MMX missed the endpoint (8.3%, p=0.2876). According to the trial's protocol, the budesonide MMX treatment arms each required a p-value of 0.025 compared with placebo to achieve statistical significance. The double-blind, European trial enrolled 410 patients.

A reference arm evaluating 9 mg/day Entocort EC budesonide from AstraZeneca plc (LSE:AZN; NYSE:AZN) showed that 12.6% of patients achieved remission, though Cosmo said the trial was not powered to show a statistical difference between the Entocort EC and budesonide MMX treatment arms. ...