Synta encouraged by phase II Crohn’s disease data

STA-5326 is the first oral, small-molecule, and highly selective inhibitor of the IL-12 cytokine family, including IL-12 and IL-23, cytokines that play a central role in Crohn’s disease and other chronic inflammatory diseases.

At daily doses of 35mg and above, treatment with STA-5326 showed clinically meaningful response and disease remission rates in patients with active Crohn’s disease. STA-5326 was also generally well tolerated over four weeks of administration.

Meaningful clinical activity was observed at all dose levels except the lowest administered dose level of 14mg twice-a-day. Results from the 35mg once-a-day dose cohort showed that 82% of patients showed a decrease of 70 points or more at week four in the Crohn’s disease activity index (CDAI), the standard measurement of disease severity for this condition.

In addition , 63% of patients achieved the more stringent criterion of a decrease of 100 points or more at week four in CDAI score based on an additional analysis, and 36% of patients achieved clinical remission as determined by a CDAI score of less than 150 points at week four.

“These results suggest STA-5326 is generally well tolerated in Crohn’s disease patients, that the higher doses tested may increase clinical rates of response and remission, and that once-a-day dosing may be effective in patients with active disease,” said Dr Matthew Sherman, senior vice president and chief medical officer at Synta. “Based on these preliminary data, we expect to initiate a large, randomized, double-blind, placebo-controlled phase IIb trial by the end of the year.”