From Seeking Alpha News Feed. It sounds very successful to me, for a disease notoriously hard to treat.
Saul
Celgene’s Crohn’s disease candidate successful in Phase 2 study • 8:27 AM
Douglas W. House, SA News Ed…
In a study published in the New England Journal of Medicine, a Phase 2 study evaluating Celgene’s (NASDAQ:CELG) investigational oral antisense therapy, GED-0301, in patients with Crohn’s disease demonstrated statistically significant efficacy compared to placebo at certain doses.
The 166-subject trial enrolled patients with moderate-to-severe Crohn’s disease, defined as Crohn’s Disease Activity Index ((CDAI)) scores of 220 to 400 (scores <150 indicate remission, >450 severe disease). Patients were randomly assigned to receive treatment for two weeks with one of three daily doses of GED-0301 (10 mg, 40 mg, 160 mg tablets) or placebo and then evaluated for responses at Days 15, 28 and 84. The primary efficacy endpoint was the percentage of patients achieving clinical remission (CDAI score <150) at Day 15, maintained at Day 28.
65% of patients receiving GED-0301 160 mg and 55% of those receiving 40 mg met the primary endpoint compared to 12% for the 10 mg cohort and 10% for placebo (p < 0.001).
The proportion of patients in the 160 mg cohort achieving clinical remission (CDAI score < 150) on Day 15, Day 28 and Day 84 was 67%, 72% and 67%, respectively, versus 21%, 14% and 21%, respectively, for placebo (p < 0.0001). The proportions for the 40 mg and 10 mg cohorts were 58%, 70% and 63% and 15%, 29% and 29%, respectively. The results for the 10 mg group did not reach statistical significance compared to placebo.
On Day 28, 37%, 58% and 72% of patients treated with 10 mg, 40 mg or 160 mg once daily achieved a clinical response (a 100-point reduction in CDAI score, a secondary endpoint) compared to 17% for placebo (p = 0.04, p < 0.001, p < 0.001, respectively).
Celgene intends to advance GED-0301, which it licensed from Dublin, Ireland-based Nogra Pharma about a year ago, to Phase 3 development.