Takeda drug impresses in ulcerative colitis study

More than 40 percent of patients with moderate to severe ulcerative colitis achieved clinical remission from the debilitating condition after a year of taking an experimental drug developed by Japan's Takeda Pharmaceutical Co, according to data from a pivotal late-stage trial.

The biologic drug, vedolizumab, met the goals of the Phase III trial with highly statistically significant advantages in rates of remission, clinical response and bowel healing compared with a placebo, researchers said.

Of the patients taking part in the year-long maintenance study, 44.8 percent of those who received vedolizumab every four weeks and 41.8 percent who got the drug every eight weeks were deemed to be in clinical remission at week 52. That compares with 15.9 percent for those who received a placebo.

In a subset of patients who were not also taking a steroid for the condition, the remission rate was 45.2 percent for those who got the Takeda drug every four weeks compared with 13.9 percent in the placebo group.

"The maintenance study data are really spectacular," said Dr Brian Feagan, the trial's lead investigator who presented the data on Tuesday at the Digestive Disease Week meeting in San Diego.

"I think this is a pretty exciting result and has big implication for patient care ultimately," added Feagan, who said he believes the data to be strong enough for the drug to gain approval.

Clinical remission was defined as a score of 2 points or less on the 12-point Mayo scale of disease activity. A Mayo score of 6-12 indicates moderate-to-severe disease.

Ulcerative colitis is a chronic condition that affects roughly 700,000 Americans, and often strikes younger, active people. Common symptoms include diarrhea, rectal bleeding, incontinence, abdominal pain, fever, fatigue and weight loss.

The ulcerative colitis market is expected grow nearly 6 percent annually to about $3 billion by 2020, according to a recent report from Decision Resources, which provides analysis of biopharmaceutical industry data.

Vedolizumab, which is given intravenously, belongs to a different class of biologic drugs than the TNF blockers widely used to treat colitis and other inflammatory diseases, such as Johnson & Johnson's Remicade and Abbott Laboratories' Humira. The drug targets a protein present in a small percentage of white blood cells that have been shown to play a role in controlling inflammation.

The anti-TNF drugs, while highly effective, suppress the immune system and have been associated with infections and other serious complications, such as tuberculosis.

"It would be nice to have a drug that didn't do that," Feagan said. "There was no increased risk of serious infection or any infection over placebo. It's pretty striking actually."

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