Sargramostim falls short in Crohn's trials

German drugmaker Schering AG says that a recently completed trial of the synthetic growth factor sargramostim in the treatment of Crohn's disease has not met its primary endpoint. The company added that data from the Phase III NOVEL 4 (New Opportunities to Verify Evolving Logic in Crohn's disease) trial did suggest a treatment benefit, but failed to demonstrate superiority to placebo, in terms of response/and or remission, after eight weeks of treatment.

In the NOVEL 2 study, the drug did achieve both of its primary endpoints, in that it was significantly more effective than placebo at inducing corticosteroid-free clinical remission in steroid-dependent Crohn's disease patients.

Marc Rubin, a member of the executive board of the company, said: "while we are disappointed that the NOVEL 4 trial results did not uphold the significant outcomes observed in the Phase II induction trial [NOVEL 1]... we are pleased that NOVEL 2 did achieve a positive primary endpoint of steroid-free clinical remission." Prof Rubin added that the firm would conduct a full analysis of all the relevant data and will be in contact with regulators to discuss any alterations to its development program in order to make the drug available for Crohn's disease.