New drug in the fight against Crohn's disease

New drug against Crohn's disease successfully tested on patients

03/19/2015

People who suffer from Crohn's disease can hardly live a normal life. Chronic inflammatory bowel disease causes constant diarrhea and convulsive abdominal pain in those affected. A drug that physicians at the Friedrich Alexander University of Erlangen-Nuremberg (FAU) tested, now holds new hope for the patients. Depending on the dose, disease activity in subjects decreased by up to 65 percent. Their study results published the physicians in the trade magazine „New England Journal of Medicine“.

New drug reduced disease activity of Crohn's disease up to 65 percent
The Medical Clinic 1 of the University Hospital Erlangen tested the new treatment approach in collaboration with 16 Italian partner institutions. The new drug inhibits a molecule (SMAD7) that prevents the release of an anti-inflammatory messenger (TGF-ß1).

In the Phase 2 study, 160 patients with moderate to severe Crohn's disease were randomized into groups. They received different doses of the study drug Mongersen (10, 40, or 160 milligrams) or a placebo as a tablet over a two-week period. By this therapy a decrease of the illness symptoms and thus a clear improvement of the well-being of the patients should be achieved.

„We found that subjects with Crohn's disease who received Mongersen had significantly higher remission rates and showed a stronger clinical response than those receiving placebo“, the researchers write in the journal.

New drug could mean breakthrough in the therapy of Crohn's disease
The positive effects were most pronounced in the groups receiving 40 or 160 milligrams of mongersen daily: 55 percent and 65 percent, respectively, showed the desired reduction in disease activity. In the placebo group it was only ten percent. „A similar strong therapeutic effect could not be achieved in Crohn's disease with any other drug in clinical trials“, reports Prof. Neurath.

Another positive effect of the drug affects the duration of its effect. On the 84th day of the study, Neurath and his team reported clinical remission in 62 percent of subjects who received a 40-milligram dose, although the use of mongersen was only over two weeks. In the group of subjects who took 160 milligrams of the drug, the doctors were even able to observe the positive effect at 67 percent. Neurath sees the high efficacy of the drug as a breakthrough in the fight against Crohn's disease, but this must be confirmed by further studies. In other anti-inflammatory agents used so far, according to the medical profession, after the discontinuation of the drug, symptoms of disease rapidly returned. Another argument that speaks for Mongersen concerns the side effects that did not occur more than in the placebo group. (Ag)