Budesonide MMX: Phase III data
Top-line data from the double-blind, European Phase III CB-01-02/02 trial in 410 patients showed that once-daily 9 mg oral budesonide MMX met the primary endpoint of superiority to placebo in the proportion of patients achieving clinical remission as measured by UCDAI score at week 8 (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.
A reference arm evaluating 9 mg/day Entocort EC budesonide from AstraZeneca plc (LSE:AZN; NYSE:AZN, London, U.K.) showed that 12.6% of patients achieved remission, though the partners said the trial was not powered to show a statistical difference between the Entocort EC and budesonide MMX treatment arms. Both doses of budesonide MMX were well tolerated, and the frequency of adverse events was similar to placebo. ...