Schering's phase 3 trial of sargramostim for Crohn's disease fails to meet two primary endpoints

By Lisa Kerner

Charlotte, N.C., July 31 - Schering AG, Germany said results from the phase 3 induction trial (n.o.v.e.l. 4) of sargramostim for the treatment of Crohn's disease suggest a treatment benefit but fail to demonstrate superiority in the two primary endpoints of response and/or remission at eight weeks compared to a placebo.

N.o.v.e.l. 4 was a phase 3 multi-center, randomized, double-blind, placebo-controlled study to evaluate the induction of response and remission in 288 patients with moderately-to-severely active Crohn's disease. Patients received 6 mcg/kg/day sargramostim or a placebo via subcutaneous injection for eight weeks.

Primary and secondary endpoints were met, however, in the n.o.v.e.l. 2 study. Sargramostim was shown to be significantly more effective than a placebo for induction of corticosteroid-free clinical remission in steroid-dependent Crohn's disease patients.

"While we are disappointed that the n.o.v.e.l. 4 trial results did not uphold the significant outcomes observed in the phase 2 induction trial (n.o.v.e.l. 1), the data did trend toward a treatment benefit with sargramostim," Schering executive board member Marc Rubin said in a company news release.

Sargramostim is a man-made form of a naturally occurring growth factor.

Schering is a research-based pharmaceutical company located in Berlin, Germany.

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