Celgene Announces Positive Data For Crohn's Disease Drug

By Lori Clapper

Celgene announced positive results Monday of its double blind multicenter Phase 2 trial of its Crohn’s Disease drug, GED-0301. The company presented the data from the study, Mongersen, an Oral smad7 Antisense Oligonucleotide, in Active Crohn's Disease Tuesday at the United European Gastroenterology Week in Vienna, Austria.

The Phase 2 trial tested 166 patients with active Crohn’s disease. Researchers compared three different doses of the drug, also called Mongersen, with a group taking a placebo. After two weeks, the group taking a 10 mg dose showed little change, however results showed those who took the 40 mg pill showed 55 percent remission rates, and the 160 mg dosage group had 65 percent remission rates.

“The drug also resulted in 15 to 48 percent remission rates as compared to other currently marketed Crohn's disease drugs, including Johnson & Johnson's Remicade, AbbVie's Humira, and Biogen Idec's Tysabri,” according to ISI Group analyst Mark Schoenebaum.

Due to the favorable data, the GED-0301 is not only a potential blockbuster for Celgene, but because it is an oral dosage form, it could become a preferred therapy over popular injectable therapies like AbbVie’s Humira, The Street reported.

Scott Smith, president, Celgene Inflammation and Immunology, said GED-0301 “has the potential to change the treatment landscape for Crohn's disease.” He added that Celgene will be pursuing the clinical development in Phase 3 trials later this year.

Celgene plans to launch the drug in 2017 or 2018. Analysts project it will generate up to $3 billion in annual sales.

Crohn's disease is an immune-mediated, chronic inflammatory condition of the gastrointestinal tract. Crohn's disease can affect all parts of the GI tract, though it most commonly affects the end of the small bowel (the ileum) and the beginning of the colon. Currently, there is no cure for the disease.