Successful clinical trial on treatment for chronic inflammatory bowel disease
Crohn’s disease is a chronic inflammatory bowel disease in which patients suffer from frequent diarrhoea and painful stomach cramps, making it difficult to lead a normal life. Doctors at FAU have recently tested a new treatment for this disease.
The Department of Medicine 1 at Universitätsklinikum Erlangen (head of department: Prof. Markus F. Neurath) was the only German centre to test a new medication in a trial with 16 partner institutions in Italy. The treatment inhibits a particular molecule, SMAD7, that blocks the expression of the anti-inflammatory messenger substance TGF-beta 1.
In the phase 2 trial, 160 patients with moderate to severe Crohn’s disease were split into groups at random and given different doses (10, 40 or 160mg) of Mongersen – the medication being studied – or a placebo in tablet form. The participants took the tablets once a day for two weeks. The aim of the treatment was to achieve clinical remission, i.e. a reduction in symptoms, thereby improving the patients’ well-being considerably.
This was particularly successful in the two groups administered daily doses of 40 and 160 milligrams orally. In these groups 55 and 65 percent of patients respectively experienced the desired reduction in disease activity, compared with only 10 percent in the placebo group. ‘No other medication has had such a strong therapeutic effect on Crohn’s disease in clinical trials before,’ explains Prof. Neurath.
Furthermore, the effect lasted for a long period of time – over three months – despite the fact that the patients only took the medication for two weeks. On the 84th day of the trial, 62 percent of the participants who had been given 40 milligrams of Mongersen were in clinical remission, while in the group that received 160 milligrams this figure was even higher at 67 percent. Prof. Neurath sees this efficacy as a potential breakthrough in the treatment of Crohn’s disease that must be confirmed in further trials. When other anti-inflammatory substances that are currently available have been used, the symptoms returned rapidly after patients stopped taking the medication. The patients who took Mongersen experienced no more side effects than those in the placebo group.
The trial was published in the New England Journal of Medicine on 19 March.
Giovanni Monteleone, Neurath MF et al., Mongersen, an Oral SMAD7 Antisense Oligonucleotide, and Crohn’s Disease, N Engl J Med 2015;372:1104-13.
Information for the press:
Prof. Dr. med. Raja Atreya
Phone: +49 9131 8545107