The clinical development program for CombiGene's CG01 project, which is being developed to treat drug-resistant focal epilepsy, was originally planned to be performed in Europe, CombiGenes home market. Since CombiGene and Spark Therapeutics in October this year entered an exclusive collaboration and licensing agreement for CG01, the two companies have jointly reviewed the future development of the project with the ambition to establish the best path forward.
The most significant outcome of this review is the decision to expand the clinical development program to include clinics in the U.S. as well as in Europe. The U.S. is the world's pharmaceutical market and to establish a clinical presence there adds much further strength to the CG01 project. In order to prepare CG01 to meet the needs of a global submission the remaining preclinical program will be expanded and, in some parts, complemented with additional studies. In practice, this means that the preclinical part of CG01 will take longer to finalize.