Isis Drug Fails to Work in Crohn’s Disease

Isis Pharmaceuticals Inc. said on Thursday a trial of its experimental drug for Crohn’s disease did not work in a late stage clinical trial.

But an improved version of the product, in enema form, showed a benefit in patients with ulcerative colitis in several mid-stage trials. The Phase III trial of the intravenous drug, alicaforsen, did not show a statistically significant rate of remission compared to a placebo in patients with Crohn’s disease and the company said it will not invest further to develop the drug for the disease. Crohn’s disease is a chronic inflammation of the intestinal wall that can affect any part of the digestive tract. It can cause chronic diarrhea, abdominal pain, loss of appetite and weight loss. It can also lead to intestinal abscesses. Isis is a pioneer in the development of drugs based on antisense technology, which aims to stop the progression of a disease at an earlier stage than traditional therapies. Ulcerative colitis is similar to Crohn’s. The large intestine becomes inflamed and ulcerated leading to bouts of bloody diarrhea, cramps and fever. The mid-stage, or Phase II trials of alicaforsen in enema form for ulcerative colitis showed significant and long-lasting improvement, and the company said it will proceed with Phase III trials of that treatment. The enema, at 240 milligrams, showed that patients treated over six weeks had a greater response than those taking a placebo. They also had improved mucosal healing, decreased rectal bleeding and less diarrhea, the company said. Isis said it believes the durability of response could be a key competitive advantage for the drug. Relief from the disease can last six months or longer than those treated with placebo or the current enema standard of care, the company said. Isis’s shares fell 4.5 percent to $4.70 in electronic trading before the market opened, from a close on Wednesday of $4.92 on Nasdaq. (Source: Reuters, Dec 2004)