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4SC AG — Regulatory Filings 2012
Jun 18, 2012
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Corporate | 18 June 2012 07:30
Press Release: 4SC’s lead autoimmune product vidofludimus shows convincing preclinical evidence in a kidney transplantation model
4SC AG / Key word(s): Miscellaneous
18.06.2012 / 07:30
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Press Release
4SC's lead autoimmune product vidofludimus shows convincing preclinical evidence in a kidney transplantation model
– New preclinical data published in peer-reviewed article in Transplantation
– Vidofludimus significantly prolongs survival in a rat kidney transplantation model compared to placebo, improves parameters of acute transplant rejection and shows protective effects on kidneys
Planegg-Martinsried, 18 June 2012 – 4SC AG (Frankfurt, Prime Standard: VSC), a discovery and development company of targeted small molecule drugs for autoimmune diseases and cancer, announces that convincing new preclinical data featuring its lead autoimmune product vidofludimus (4SC-101) have been published in a peer-reviewed article in scientific journal Transplantation (15 June 2012, Volume 93, Issue 11, p. 1101-1107) . The data show that vidofludimus prolongs survival after kidney transplantation paralleled by amelioration of histological signs of acute transplant rejection in a preclinical model. Furthermore, in a remnant kidney model vidofludimus had no worsening effects on kidney function and even showed protective effects on kidneys by slowing kidney fibrosis. Vidofludimus, an oral inhibitor of IL-17A and IL-17F and of DHODH, has demonstrated strong anti-inflammatory activity and good safety in several preclinical and clinical studies in various autoimmune indications. 4SC is currently engaging in talks with potential partners to prepare a Phase IIb study with vidofludimus in the indication inflammatory bowel disease (IBD).
The data published in the current issue of Transplantation demonstrate that animals treated with vidofludimus after a kidney transplantation showed significantly longer survival than placebo treated animals (p<0.001). That effect was paralleled by less severe histological features of acute kidney rejection 3 and 5 days after the transplantation: In the vidofludimus treatment group the invasion of immune cells into the transplanted tissue (interstitial and perivascular infiltration) as well as observed inflammation of the kidney tubules (tubulitis) were considerably lower compared to the placebo group. In addition, 5 days after transplantation lower levels of the pro-inflammatory cytokine IL-17 were expressed in the vidofludimus group compared to placebo treated animals.
Since in the past many immunosuppressant agents administered in transplantation medicine have shown toxic effects on kidneys, the impact of vidofludimus on kidney function was investigated in a preclinical model. In this remnant (5/6 nephrectomy) kidney model, vidofludimus was shown to have a protective effect on kidney cells and to improve certain kidney functions. In detail, vidofludimus compared to placebo reduced proteinuria, glomerulo sclerosis and kidney tissue fibrosis. Generally, vidofludimus reduced the infiltration of immune cells (T lymphocytes and macrophages) in the kidney tissue and caused a significant reduction of IL-17 levels. These findings indicate that these mechanisms were most probably responsible for ameliorated acute rejection after kidney transplantation.
Dr. Ulrich Dauer, CEO of 4SC AG said: 'These novel preclinical data in a transplant rejection model now published in Transplantation , once again demonstrate the broad potential of vidofludimus as a novel therapy for autoimmune diseases and chronic inflammation. Vidofludimus was able to prolong the survival time and ameliorate features of acute rejection after kidney transplantation in a preclinical model. Therefore, vidofludimus seems to be a promising immunomodulatory drug also in transplantation medicine. Since vidofludimus has been shown to be safe in several human clinical trials already, clinical development of vidofludimus in transplantation medicine might be a further therapeutic option in the future. The published data also reinforce our planned clinical Phase IIb study in IBD which we are currently preparing in talks with regulatory authorities and potential partners'.
Ends
Details of the Publication:
Publication: Transplantation ( 15 June 2012, Volume 93, Issue 11, p. 1101-1107)
Title: 'Immunosuppression with 4SC-101, a novel inhibitor of dihydroorotate dehydrogenase, in a rat model of renal transplantation'
Authors: Krisztina Rusai 1 , Christoph Schmaderer 1 , Marcus Baumann 1 , Stefan Chmielewski 1 , Ágnes Prókai 2 , Attila J. Szabó 2 , Johann Leban 3 , Robert Doblhofer 3 , Aldo Ammendola 3 , Jens Lutz 1 , Uwe Heemann 1
1 Department of Nephrology, Klinikum rechts der Isar, Munich, Germany
2 First Department of Pediatrics, Semmelweis University, Budapest, Hungary
3 4SC AG, Planegg-Martinsried, Germany
About Vidofludimus
Vidofludimus is a novel, orally administered small molecule for the treatment of autoimmune disorders such as 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 IFN-gamma that play 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 Phase IIa trial in inflammatory bowel disease meeting the primary endpoint with a response rate of 88.5% and has completed a Phase IIb study in rheumatoid arthritis showing substantial anti-inflammatory activity. Preclinical models demonstrate the broad therapeutic potential of vidofludimus in autoimmune indications including lupus, psoriasis, multiple sclerosis and transplant rejection.
About the rationale of testing vidofludimus in transplantation medicine
There is a considerable incidence of acute rejection in kidney transplantation caused by the body's immune system. Therefore, immune suppression plays a key role in clinical transplantation medicine. Standard immunosuppressive drugs, however, have several negative long-term side-effects. Therefore, the need for optimization of immune suppression as well as the search for alternative well tolerated drugs, are important fields of research in transplantation medicine. Since vidofludimus – as a targeted immunomodulatory agent – has shown a very clean safety profile and considerable anti-inflammatory activity in several clinical studies in autoimmune indications, there is a strong rationale of investigating the drug also in the field of transplantation medicine.
About 4SC
The Group managed by 4SC AG (ISIN DE0005753818) discovers and develops targeted, small-molecule drugs for treating diseases with high unmet medical needs in various autoimmune and cancer indications. These drugs are intended to provide 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 had 90 employees at 31 March 2012. 4SC AG has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.
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.
For more information please visit www.4sc.com or contact:
4SC AG
Jochen Orlowski, Corporate Communications & Investor Relations
jochen.orlowski(at)4sc.com, Tel.: +49 (0) 89 70 07 63 66
MC Services
Raimund Gabriel
raimund.gabriel(at)mc-services.eu, Tel.: +49 (0) 89 21 02 28 30
End of Corporate News
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| Language: | English |
| Company: | 4SC AG |
| Am Klopferspitz 19a | |
| 82152 Martinsried | |
| Germany | |
| Phone: | +49 (0)89 7007 63-0 |
| Fax: | +49 (0)89 7007 63-29 |
| E-mail: | [email protected] |
| Internet: | www.4sc.de |
| ISIN: | DE0005753818 |
| WKN: | 575381 |
| Listed: | Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin, Düsseldorf, München, Stuttgart |
| End of News | DGAP News-Service |
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