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4SC AG. (6/8/11). "Press Release: 4SC Announces Topline Results of Phase IIb Trial of Vidofludimus in Rheumatoid Arthritis". Planegg-Martinsried.

Organisation Organisation 4SC AG (FSE: VSC)
  Group 4SC (Group)
Products Product vidofludimus (4SC-101)
  Product 2 placebo
Person Person Dauer, Ulrich (Probiodrug 201805– CEO before Omeicos + Activaero + 4SC + Tripos)
     


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.

ACR Efficacy Results at Week 13:

Treatment N ACR20 ACR50 ACR70
35 mg Vidofludimus 120 60 (50.0%) 31 (25.8%) 15 (12.5%)
Placebo 116 52 (44.8%) 20 (17.2%) 7 (6.0%)

*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.'

- ENDS -

Conference Call
The senior management team of 4SC will host a conference call today at 3.30pm CET (9.30am EST) to inform about the topline results of the COMPONENT study.

Dial-in numbers:
0800 10 12 072 (Germany)
0800-358-0886 (UK)
1-877-941-1469 (USA)
+49 (0) 6958 999 0805 (other countries)

Conference ID: 4445541

Approximately two hours after the conference call, an audio replay of the conference will be available on the 'investors/events&presentations/presentations' section of www.4sc.com.

For more information please contact:

4SC AG
Dr Ulrich Dauer, Chief Executive Officer
Tel.: +49 (0) 89 70 07 63 0
Yvonne Alexander, IR & PR
Tel.: +49 (0) 89 70 07 63 66

MC Services (Europe)
Raimund Gabriel
Tel.: +49 (0) 89 21 02 28 40

The Trout Group (USA)
Chad Rubin
Tel.: +1 646 378 2947


Notes to Editor:

About the COMPONENT study

The COMPONENT study is a randomised, double-blind, placebo-controlled, multi-centre, international Phase IIb study evaluating the efficacy of vidofludimus with methotrexate, compared to methotrexate alone, in rheumatoid arthritis (RA) patients. The primary endpoint of this study is the estimation of ACR20 at week 13, secondary endpoints are ACR50, ACR70, DAS28, safety parameters and pharmacokinetics. The trial enrolled 241 patients in two study arms across 28 sites in Poland, Romania, Bulgaria and Czech Republic. In the first study arm patients received 35mg of vidofludimus given orally once-daily plus methotrexate, in the second study arm patients received placebo plus methotrexate. The study duration was 13 weeks and eligible patients must have had active RA, have received weekly doses of MTX (10 25 mg/week) for a minimum of 3 months prior to Day 1 dosing, and have received a stable MTX dose for at least 6 weeks prior to Day 1 dosing.

More information about the COMPONENT study can be found on www.clinicaltrials.gov (Identifier NCT01010581).

About Vidofludimus

Vidofludimus is a novel, orally administered small molecule for the treatment of autoimmune disorders such as rheumatoid arthritis and inflammatory bowel disease. The therapeutic efficacy of vidofludimus is based on a dual principle. Vidofludimus inhibits the expression of selected pro-inflammatory cytokines, including interleukin-17 (IL-17A and IL-17F) and INF-gamma that have crucial pathogenic roles in a variety of autoimmune diseases. Vidofludimus also inhibits dihydroorotate dehydrogenase (DHODH), a key enzyme of the pyrimidine biosynthesis, thereby halting the proliferation of activated T and B cells which are involved in the pathology of autoimmune disorders. Vidofludimus has completed a successful Phase IIa trial in inflammatory bowel disease. In addition, various preclinical models demonstrate the application options of vidofludimus in further autoimmune indications such as lupus, psoriasis, multiple sclerosis and transplant rejection.


About 4SC

4SC (ISIN DE0005753818) discovers and develops targeted, small-molecule drugs for the treatment of diseases with a high unmet medical need in various autoimmune and cancer indications. These drugs are intended to provide patients with innovative treatment options that are more tolerable and efficacious than existing therapies, and provide a better quality of life. The company's balanced pipeline comprises promising products that are in various stages of clinical development. 4SC's aim is to generate future growth and enhance its enterprise value by entering into partnerships with leading pharmaceutical companies.

Founded in 1997, 4SC currently has 94 employees and has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.

For further information, please visit www.4sc.com.


Legal Note

This document may contain projections or estimates relating to plans and objectives relating to our future operations, products, or services; future financial results; or assumptions underlying or relating to any such statements; each of which constitutes a forward-looking statement subject to risks and uncertainties, many of which are beyond our control. Actual results could differ materially, depending on a number of factors.

   
Record changed: 2017-04-02

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