4SC Announces Topline Results of Phase IIb Trial of Vidofludimus in Rheumatoid Arthritis
News Jul 27, 2011
4SC AG, has announced topline results from its randomized, double-blind, placebo-controlled Phase IIb clinical trial COMPONENT in RA.
This compared vidofludimus, an oral inhibitor of DHODH and pro-inflammatory cytokines (including IL-17A and IL-17F as well as INF-gamma), in rheumatoid arthritis patients on methotrexate background therapy versus methotrexate monotherapy over a treatment period of 13 weeks.
ACR20 response improvement of the 35 mg vidofludimus group compared to placebo was statistically significant (p<0.05) at week 2 (16.7% vs. 6.9%) and week 8 (46.7% vs. 31.9%), however, vidofludimus missed the primary endpoint of significantly improving ACR20 response at week 13 (50.0% vs. 44.8%).
Time to ACR20 response was significantly (p<0.05) shorter in the vidofludimus group compared to placebo (median 56 days vs. 92 days). The patient group treated with vidofludimus also reported higher ACR50 (25.8% vs. 17.2%) and ACR70 (12.5% vs. 6%) response rates compared to placebo at week 13.
Overall, vidofludimus was safe and well tolerated. No obvious differences in the adverse event rate between the vidofludimus and placebo group were observed. In particular, there were no relevant increases of diarrhea, neutropenia, anemia, hypertension, cholesterol or liver enzyme levels.
Only one serious adverse event was reported in the vidofludimus group which was judged as not related to vidofludimus. No deaths occurred. These safety results were consistent with previous Phase IIa trial results in RA and inflammatory bowel disease patients.
4SC will continue to analyze the current data set and the new data that will become available in the weeks ahead. The Company will use this data and data from previous trials to continue its discussions with potential partners.
Meanwhile 4SC’s future development of vidofludimus will be focused on inflammatory bowel disease (IBD) and, potentially, other autoimmune indications such as lupus and psoriasis.