Cebix AB
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Cebix AB is the wholly owned European affiliate of Cebix Incorporated.
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It is primarily an R & D focused affiliate, which is fully integrated within the Cebix global R & D effort.
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The research team is located at the Karolinska Institute in Stockholm, Sweden.
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The team has a leadership role in the assessment of the clinical benefit of C-peptide therapy in diabetic nephropathy
John Wahren, M.D., Ph.D., Chief Scientific Officer & Executive Board Member
Dr. Wahren is Emeritus Professor of Clinical Physiology at the Karolinska Institute in Stockholm, Sweden, from where he received his M.D. and Ph.D. John is co-founder of Cebix Incorporated and also is its Chief Scientific Officer and a member of the Board of Directors. During 1973 to 2002 he was active at the Karolinska Institute and Karolinska University Hospital with a scientific focus on diabetes and metabolic disorders. John did post-graduate training at Peter Bent Brigham Hospital, Harvard University in 1976 and was visiting professor at the University of Lausanne, Switzerland in 1984. His bibliography includes approximately 400 articles in peer-reviewed journals and text books. John has been a member and chairman of the Nobel Assembly and Nobel Committee, Karolinska Institute during 1976 to 2002. He has been editor and associate editor of several scientific journals in the diabetes field and from 1987 to 1989 he was Medical Director of Kabi Vitrum Nutrition AB, Stockholm.
Åsa Kallas, Ph.D., Program Manager
Dr Kallas has a background in chemical engineering and close to ten years of experience from academic research within molecular biology, protein expression and protein characterization. Åsa holds a Ph.D. in Biotechnology from the Royal Institute of Technology, Stockholm Sweden and she was a post-doctoral fellow at the Structural Genomic Consortium, Karolinska Institutet, Stockholm, Sweden between 2006 and 2009. Åsa joined Cebix AB in January 2010.
Cebix AB
Fogdevreten 2
SE-171 65 Solna, Sweden
Cebix is developing ErsattaTM, a proprietary disease-modifying replacement peptide for the treatment of complications associated with diabetes. Ersatta is a long-acting form of C-peptide, a naturally-occurring biologically-active peptide that is formed when insulin is cleaved from pro-insulin.
Pioneering work by the scientific community and Cebix scientists strongly suggests that lack of endogenous C-peptide, together with hyperglycemia, contributes to the pathogenesis of long-term complications of diabetes. Studies in animal models of type 1 diabetes, and early phase clinical trials in patients with type 1 diabetes demonstrated a protective effect of C-peptide treatment in diabetes-induced microcirculation abnormalities of the kidneys, peripheral nerves, and central nervous system (2-5). Furthermore, the functional improvements occurred despite both unchanged glycemic control and blood pressure. In patients with type 1 diabetes, C-peptide administration in physiological replacement doses was safe and well tolerated. These results identify C-peptide as a promising novel therapeutic candidate in the treatment of type 1 diabetes.
In clinical trials conducted to date, C-peptide has been administered as an aqueous solution requiring subcutaneous injection four times daily. Ersatta is a proprietary mono-pegylated version of C-peptide that has improved pharmacokinetic properties compared to the native peptide. Pegylation of C-peptide extends the drug half-life, allowing for once-weekly dosing that supports improved patient compliance.
Cebix is conducting a Phase 1b clinical trial of Ersatta in patients with type 1 diabetes and plans to initiate a pivotal Phase 2/3 trial in diabetics with peripheral neuropathy in the first half of 2012.
This project is the first of its kind to explore a treatment that targets primary mechanisms in the development of peripheral neuropathy in type 1 diabetes. As such, Ersatta has the potential to become a disease-modifying therapy that alters the chronic prognosis of millions of diabetes patients worldwide.
References 1. Hills CE, Brunskill NJ. Clin Sci 116:565-574, 2009 2. Hills CE, Brunskill NJ, Squires PE. Am J Nephrol 31:389-397, 2010 3. Samnegård B, Jacobson SH, Wahren J, Sjöquist M. et al Nephrol Dial Transplant 20:532-538, 2005 4. Ekberg K, Brismar T, Bolinder J, Wahren J. et al Diabetes Care 30:71-76, 2007 5. Johansson BL, Borg K, Fernqvist-Forbes E, Kernell A, Odergren T, Wahren J. Diabet Med 17:181-189, 2000 6. Ekberg K, Brismar T, Johansson BL, Jonsson B, Lindstrom P, Wahren J. Diabetes 52:536-541, 2003
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