Crohn's drug shows promise in mid-stage trial

Celgene investigational Crohn's disease treatment GED-0301 (Mongersen) appear to surpass other drugs in terms of remission rates
Celgene investigational Crohn's disease treatment GED-0301 (Mongersen) appear to surpass other drugs in terms of remission rates

Mid-stage data for Celgene investigational Crohn's disease treatment GED-0301 (Mongersen) appear to surpass other drugs in terms of remission rates, a finding which, if borne out in further trials, could confer an edge over several marketed products. Celgene unveiled the Phase-II, top-line results at United European Gastroenterology Week in Vienna on Monday morning, including remission rates of up to 65%. One analyst has put potential sales for the drug in blockbuster territory.

ISI Group's Mark Schoenebaum, in an investor note this morning, wrote that GED's remission rates stacked up “favorably” to other drugs approved for Crohn's: J&J's Remicade boasts remission rates of 48%, Biogen Idec's Tysabri 32% and AbbVie's Humira 29%. All fall short of GED's 65%. No significant GED safety issues were reported in the abstract.

The drug also demonstrated a patient response at elevated doses. Patients receiving a 10mg dose per day saw remission rates of 36%, with the rate rising to 57% at 40mg/day and to 65% at 160mg/day.

Schoenebaum cautioned that the Phase-II trial was still in the early stages, however, with only two weeks' worth of data being top-lined, and that “we really need Week 4 data to better compare to approved drugs,” as most biologics are tested for one month to demonstrate remission rates. The investment firm said that peak GED sales could reach over $3 billion worldwide.

Celgene plans to begin Phase-III testing by the end of 2014, which would put a potential launch in the 2017-2018 timeframe.