
The Spanish Medicines Agency (AEMPS) has authorized Digna Biotech to start the clinical research phase with interferon alpha-5 in patients with genotype 1 chronic hepatitis C that have not healed with previous treatment. The results of the phase I/II clinical trial are expected to become available by mid-2011.
Interferon alpha-5 was discovered and patented by the CIMA of the University of Navarra, and has been developed by Digna Biotech. The preclinical development of interferon alpha-5 has been possible thanks to the financial support of the CDTI and the Government of Navarra.
It is estimated that the nonclinical (preclinical) and clinical development of interferon alpha-5 up to completion of phase II will require an investment of 14 million €, and if development is successfully completed, the product may be marketed in the year 2015. By that time, the potential market for products of this kind will be 5000 million €.
