Celgene Crohn’s Drug Benefit Supported by Image Data in Trialby and
Celgene Corp.’s experimental pill for Crohn’s disease helped more patients than analysts expected, reinforcing positive results of an earlier study and likely boosting investors’ confidence in the drug’s chances of approval.
Thirty-seven percent of patients saw an improvement of 25 percent or higher in a score measuring gut health after taking the drug, called GED-0301, Celgene said Sunday in a statement. Experts are looking for a quarter or more of patients to see that improvement, according to RBC Capital Markets analyst Michael Yee.
Doctors used an endoscope to take pictures of the digestive tracts of 63 patients to see whether ulcers in the colon and bowel had begun to heal since taking the drug. The data reported Sunday covered 52 patients with endoscopies that could be evaluated, according to the statement.
The group with the longest treatment length, at 12 weeks, had the best outcomes, with 48 percent in remission, said Celgene. The drugmaker had also tried an 8-week and a 4-week regimen.
Though small, the endoscopy trial has been closely watched by investors. GED-0301 showed remarkable results in a mid-stage trial, with more than 60 percent of patients reporting remission at the highest dose. Still, that trial was based on patient’s reported symptoms and didn’t examine their bowels. Last month, Celgene said “a proportion” of patients on the therapy had endoscopic improvements, but it didn’t release specific numbers.
Celgene’s therapy works by promoting a protein in the gut to help control immune cells that attack the digestive tract of a patient with Crohn’s disease. The condition affects more than 750,000 people in the U.S., causing abdominal pain and requiring surgery in most cases.
Some of the world’s best-selling drugs treat Crohn’s, including Johnson & Johnson’s Remicade and AbbVie Inc.’s Humira. Yet about a quarter of Crohn’s patients don’t respond to that class of medicines, known as anti-TNFs, prompting drugmakers such as Biogen Inc., Gilead Sciences Inc. and Roche Holding AG to try new approaches at tamping down the autoimmune disorder.
Celgene paid $710 million upfront in 2014 to buy the rights to GED-0301 from Nogra Pharma Ltd., a closely held drug developer based in Dublin.