FDA Halts Crohn's Disease Trial


The FDA a stop to Celgene’s REVOLVE trial and extension trial for GED-0301 (mongersen), an oral compound currently not approved for any uses.

A phase 3 trial for an investigational Crohn’s disease (CD) therapy has been discontinued following a US Food and Drug Administration (FDA) Data Monitoring Committee recommendation.

The FDA committee recommended a stop be made to trials testing Celgene’s REVOLVE trial and extension trial (SUSTAIN) for GED-0301 (mongersen), an oral compound currently not approved for any uses.

The committee made the recommendation this month, upon overall benefit/risk consideration in a recent interim futility analysis. There were no clinically meaningful safety imbalances identified in the analysis, according to Celgene.

Mongersen, an Smad7 protein-decreasing oligonucleotide, was considered for CD due to its impact on TGF beta-1 signaling. The Smad7 protein interferences with the signaling leads to increased inflammation in CD patients.

At the time of the decision, the phase 3 DEFINE trial had not been initiated, and Celgene is awaiting review from phase 2 trial datasets for mongersen’s treatment of ulcerative colitis (UC). Next steps regarding the drug will be made when the data is reviewed.

Scott Smith, president and chief operating officer for Celgene, thanked the patients and investigators of the REVOLVE trial.

“Crohn's disease is a debilitating condition with few effective long-term treatment options,” Smith said. “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.”

A press release regarding the decision was made available.

This article was originally published by MD Magazine.

Related Videos
Catalyst Trial, Diabetes, Hypertension | Image Credit: grinny - stock.adobe.com
male pharmacist using digital tablet during inventory in pharmacy | Image Credit: sofiko14 - stock.adobe.com
Pharmacist holding medicine box in pharmacy drugstore. | Image Credit: I Viewfinder - stock.adobe.com
Pharmacy Drugstore Checkout Cashier Counter | Image Credit: Gorodenkoff - stock.adobe.com
Medicine tablets on counting tray with counting spatula at pharmacy | Image Credit: sutlafk - stock.adobe.com
Capsules medicine and white medicine bottles on table | Image Credit: Satawat - stock.adobe.com
Human cell or Embryonic stem cell microscope background | Image Credit: Anusorn - stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.