Celgene is abandoning late-stage testing of its experimental drug mongersen for Crohn’s disease after a Data Monitoring Committee concluded that it would be futile to continue.
The drugmaker confirmed the untimely end of the Phase III REVOLVE trial and the extension trial SUSTAIN following an interim assessment of the drug’s overall benefit/risk profile.
The company did stress that there were “no meaningful safety imbalances identified in the analysis,” but the move will still come as a huge disappointment, particularly as it also said the planned Phase III DEFINE trial in Crohn’s disease would now not be initiated.
According to the press release, “Celgene is waiting to review the full dataset from the phase II trial with GED-0301 in ulcerative colitis (UC) to determine next steps.”
“While we are disappointed with the results of REVOLVE, we remain committed to advancing our portfolio of novel medicines for patients suffering from this disease and other inflammatory bowel disorders,” said president and chief operating officer Scott Smith.
Mongersen (GED-0301) is an investigational oral antisense therapy that decreases Smad7 protein. In patients with Crohn’s disease, abnormally high levels of Smad7 interfere with anti-inflammatory pathways in the gut, leading to increased inflammation.