Date: 2017-10-19
Type of
information: Halting of the trial
phase: 3
Announcement: halting of the trial
Company: Celgene (USA - NJ)
Product: GED-0301 (mongersen)
Action
mechanism:
- antisense drug/oligonucleotide. Mongersen (GED-0301) is an antisense oligonucleotide that targets the messenger RNA (mRNA) for Smad7, thereby reducing Smad7 protein levels. In patients with Crohn\'s disease, abnormally high levels of Smad7 interfere with TGF-?1 anti-inflammatory pathways in the gut, leading to increased inflammation. The distinct formulation of the tablet is designed to release GED-0301 into the far end of the small intestine (the terminal ileum) and near the end of the colon (right colon), where it is thought to act locally to reduce Smad7 levels.
Disease: Crohn disease
Therapeutic
area: Autoimmune diseases - Inflammatory diseases - Digestive diseases
Country:
Trial
details:
Latest
news:
- • On October 19, 2017, Celgene announced that the GED-0301 (mongersen) phase III REVOLVE trial (CD-002) in Crohn's disease (CD) and the extension trial (SUSTAIN, CD-004) will discontinue. Celgene has decided to stop the trials following an October recommendation of the Data Monitoring Committee, which assessed overall benefit/risk during a recent interim futility analysis. There were no meaningful safety imbalances identified in the analysis.
- At this time, the phase III DEFINE trial (CD-003) in Crohn's disease will not be initiated. Celgene is waiting to review the full dataset from the phase II trial with GED-0301 in ulcerative colitis (UC) to determine next steps.
Is
general: Yes
