Celgene Crohns Drug Benefit Supported by Image Data in Trial

June 3, 2017 - Crohns
Celgene Crohns Drug Benefit Supported by Image Data in Trial

Celgene Corp.s experimental pill for Crohns disease helped more patients than analysts expected, reinforcing positive results of an earlier study and likely boosting investors confidence in the drugs 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 patients reported symptoms and didnt examine their bowels. Last month, Celgene said a proportion of patients on the therapy had endoscopic improvements, but it didnt release specific numbers.

Celgenes therapy works by promoting a protein in the gut to help control immune cells that attack the digestive tract of a patient with Crohns 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 worlds best-selling drugs treat Crohns, including Johnson & Johnsons Remicade and AbbVie Inc.s Humira. Yet about a quarter of Crohns patients dont 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.

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