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Celgene to stop clinical trials of Crohn's disease drug GED-0301

PBR Staff Writer Published 23 October 2017

Celgene has decided to stop the clinical trials of Crohn's disease drug GED-0301 (mongersen) due to lack of meaningful results.

The firm has decided to terminate the trials based on the recommendation of the data monitoring committee, which evaluated overall benefit/risk during a recent interim futility analysis.

Celgene will discontinue the phase III Revolve trial (CD-002) in Crohn's disease (CD) and the extension trial (SUSTAIN, CD-004).

The company will not start the phase III Define trial (CD-003) in Crohn's disease, while it will assess the full dataset from the phase II trial with GED-0301 in ulcerative colitis (UC) to determine next steps.

The investigational oral antisense therapy GED-0301 (mongersen) is an oligonucleotide that decreases Smad7 protein, helping to impact TGF-β1 signaling.

Abnormally high levels of Smad7 interfere with TGF-β1 anti-inflammatory pathways in the gut in patients with Crohn's disease.

According to the company, GED-0301 is an investigational compound, which is not approved for any use in any country

Celgene president and COO Scott Smith said: “Crohn's disease is a debilitating condition with few effective long-term treatment options.

“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."

The company is also advancing novel medicines for inflammatory bowel disease, including Ozanimod and Otezla.

Ozanimod is a novel, oral, selective and sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator in development for immune-inflammatory indications, comprising of relapsing multiple sclerosis, ulcerative colitis and Crohn's disease.

Otezla 30mg tablet is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP).