By Peter Loftus
Johnson & Johnson (>> Johnson & Johnson) said its drug Simponi improved symptoms in a majority of patients with an inflammatory-bowel disease in a new clinical trial.
The results, released at a medical conference Monday, could support expansion of the approved uses of Simponi to include treating the bowel condition, known as ulcerative colitis, which J&J estimates affects about 700,000 people in the U.S.
Simponi, which was introduced in 2009, is currently approved to treat signs and symptoms of moderate to severe rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis.
Simponi is known as an anti-tumor necrosis factor, or anti-TNF, a category that also includes J&J's older drug, Remicade, which is already approved to treat ulcerative colitis. Simponi can be self-administered by patients as an injection, while Remicade requires intravenous infusion by a health-care provider.
J&J recorded $410 million in Simponi sales for 2011; Merck & Co. (MRK), which markets the drug in certain countries outside the U.S., recorded $264 million in Simponi sales for 2011.
J&J tested Simponi in a late-stage clinical trial of more than 770 patients with moderately to severely active ulcerative colitis who had failed to respond to or tolerate certain other treatments.
Some patients received Simponi--at two different dose levels--and some received a placebo, and researchers tracked how many experienced a clinical response at six weeks after the start of treatment. Clinical response included improvements in various symptoms of ulcerative colitis such as diarrhea.
According to J&J, 51.8% and 55% of patients in the two Simponi groups, respectively, achieved a clinical response at week 6, versus 29.7% of placebo patients. The results were presented Monday at the Digestive Disease Week medical meeting in San Diego.
In a secondary measure in the trial, roughly 18.7% and 17.8% of patients in the Simponi groups had clinical remission, versus 6.3% in placebo patients.
The rates of adverse events were comparable among the Simponi and placebo groups, and J&J said the safety of Simponi in the colitis study was consistent with the drug's safety profile in the diseases for which it's already approved.
As a class of drugs, Simponi and other anti-TNFs are associated with increased risk of infections and certain forms of cancer such as lymphoma.
The data suggest Simponi could be a new treatment option for ulcerative colitis patients who don't respond to other drugs, or who prefer the convenience of a subcutaneous injection, said William Sandborn, chief of the division of gastroenterology at the University of California, San Diego, and lead investigator of the J&J-funded study.
J&J also has studied Simponi over a longer treatment duration in colitis patients, and results are expected later this year.
J&J plans to apply for U.S. and European regulatory approval of Simponi as a treatment for ulcerative colitis this year, said J&J spokesman Brian Kenney.
Abbott Laboratories (>> Abbott Laboratories) also has applied for regulatory approval of its anti-inflammatory drug, Humira, as a treatment for ulcerative colitis. European regulators have approved the new indication.
Last year, the FDA declined to approve J&J's requests to market Simponi's ability to inhibit progression of structural damage in both rheumatoid arthritis and psoriatic arthritis.
-By Peter Loftus, Dow Jones Newswires; +1-215-982-5581; [email protected]