Shares in Celgene Corp have risen steadily following promising mid-stage data of its closely-watched Crohn’s disease drug mongersen.
Ahead of a presentation tomorrow at the United European Gastroenterology Week in Vienna, an abstract on mongersen, also known as GED-0301, has been published. Celgene got hold of the first-in-class oral antisense oligonucleotide by paying Ireland’s Nogra Pharma $710 million upfront in April.
In the Phase II trial, patients were randomised to mongersen 10, 40 or 160 mg/day or placebo for two weeks and the primary outcomes were clinical remission (maintained for two weeks) and safety.
Clinical remission was achieved by significantly greater proportions of patients receiving mongersen 40 (55.0%) and 160 mg/day (65.1%) compared with placebo (9.5%), while no notable difference was seen for 10 mg/day. The rate of response was significantly greater among patients receiving 10 (36.6%), 40 (57.5%) or 160 mg/day (72.1%) of mongersen vs placebo (16.7%).
The drug, which has caused much excitement among observers these past few months, targets the messenger RNA for Smad7, abnormally high levels of which lead to increased inflammation. Celgene says the distinct formulation of the tablet is designed to release mongersen into the far end of the small intestine and near the end of the colon, where it reduces Smad7 levels.
Phase III trials are set to start by the end of the year and if all goes to plan, mongersen would compete with the injectable biologics approved for Crohn’s, notably Johnson & Johnson/MSD’s Remicade (infliximab) or AbbVie’s Humira (adalimumab). Scott Smith, president of Celgene inflammation and immunology, says that the drug “has the potential to change the treatment landscape for Crohn’s” and the results went down well with investors.
Celgene ended the day up 4.4% at $92.00, the biggest gainer on the Nasdaq 100.
