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4SC AG (VSC.DU) Says Vidofludimus Trial Missed Primary Efficacy Endpoint In RA



6/10/2011 7:12:13 AM

PLANEGG-MARTINSRIED, Germany--(BUSINESS WIRE)--4SC AG (Frankfurt, Prime Standard: VSC), a discovery and development company of targeted small molecule drugs for autoimmune diseases and cancer, today announced topline results from its randomised, double-blind, placebo-controlled Phase IIb clinical trial COMPONENT in RA. The trial 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 and ACR70 response rates compared to placebo at week 13. *All patients were on stable doses of methotrexate throughout the trial

*Confirmatory analysis of the primary efficacy endpoint (ACR20) has been performed for all randomized and exposed patients with a minimum of efficacy data available, i.e., at least one post-baseline efficacy observation (full analysis set included 236 patients)

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 being related to vidofludimus. No deaths occurred. These safety results are consistent with previous Phase IIa trial results in RA and inflammatory bowel disease (IBD) patients.

'Even though we did not reach the primary efficacy endpoint,' said Dr Ulrich Dauer, CEO of 4SC AG, 'it is important to note that vidofludimus demonstrated efficacy in certain secondary parameters and showed very good tolerability in RA patients. We will continue to evaluate the novel mechanism of action of vidofludimus and use this new data set as an opportunity to advance our partnering discussions. We will continue our efforts for this compound in IBD and potentially other autoimmune indications such as lupus and psoriasis. Our Phase IIa trial in IBD achieved an excellent response rate of 88.5% and met the primary endpoint, both in Crohn's disease and ulcerative colitis patients. We feel this indication addresses an area of high unmet medical need that continues to be commercially attractive to potential partners and warrants the further development of vidofludimus based on the promising trial results.'

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