The study’s primary endpoint was the frequency of remission, designed as a CDAI score of less than 150 on day 15 (the day after their last investigational dose) that was then maintained through day 28 of the study. This endpoint occurred in 65% of the 43 patients who received the highest mongersen dosage, 160 mg/day, in 55% of patients who received 40 mg/day of mongersen, in 12% of patients who received 10 mg/day of mongersen, and in 10% of placebo patients. The differences were statistically significant for the two highest drug dosages.
At 84 days into the study, 10 weeks after receiving their final dosage of mongersen, the rate of patients who were given the highest dosage and continued to have a CDAI of less than 150 stood at 67%, Dr. Monteleone reported. An additional analysis focused on the 61% of patients who entered the study with a C-reactive protein level greater than 3 mg/L. Within this subgroup, 68% of patients who received the highest mongersen dosage achieved remission compared with 12% of patients who received placebo, a statistically significant difference.
The safety analysis showed that mongersen was safe and well tolerated, with low rates of total and serious adverse events that were similar across all four treatment arms. Patient follow-up also showed no clinically meaningful changes in laboratory values, vital signs, physical findings, or strictures.
Celgene has stated that it will proceed into phase III testing of mongersen.
The study was sponsored by Nogra, and then subsequently by Celgene which acquired a license for morgensen from Nogra. Dr. Monteleone has received research support from Nogra and from several other companies and has been a speaker on behalf of AbbVie and Zambon. Dr. Danese has been a consultant to several drug companies.
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