SYGNIS Pharma AG, with registered offices in Heidelberg, is a specialised pharmaceutical company listed on the Prime Standard of the German Stock Exchange. The operating activities of SYGNIS Pharma AG focus on the research and development of innovative therapies for the treatment of disorders of the central nervous system, for which there are currently no or only inadequate therapeutic options available. In this field, SYGNIS is concentrating on the clinical development of its drug candidate AX200 for the treatment of acute stroke and on its pre-clinical KIBRA project for the treatment of various forms of dementia.
AX200, the most advanced product candidate, is currently being tested in a multinational phase II pivotal efficacy study to verify its effectiveness in the treatment of patients who have suffered an acute ischemic stroke (AXIS 2). The administration of AX200 boosts the endogenous protective reaction of the body to the damaged nerve cells. This demonstrates the value of a multiple therapeutic approach: AX200 stops neuronal cell death in the acute phase of the disorder. At the same time, it stimulates the regeneration of the nervous tissue that has already been damaged by the induction of new nerve cells and blood vessels and by the reorganisation of the neuronal networks. In August 2011, SYGNIS has successfully completed the recruitment of all 328 stroke patients planned for the AXIS 2 study. The initial findings of the study are expected towards the end of 2011. Based on these findings, SYGNIS will evaluate the options for the further development or commercialization of AX200. In this regard SYGNIS might start an additional clinical study, aimed to confirm the efficacy of AX200 for the treatment of acute stroke, by itself or together with an appropriate pharma partner or out-license the entire AX200 project.
With the KIBRA project, SYGNIS is pursuing a new approach in the development of innovative methods for the treatment of dementia disorders. The ultimate goal is to develop drugs that significantly improve learning ability and memory performance through the pharmaceutical modulation of the KIBRA pathway in order to create novel concepts for the treatment of dementia disorders resulting from a wide range of different causes. Now that proof of principle has been established on the basis of in vivo and in vitro studies as part of the KIBRA project, the Company has launched a programme based on its proprietary assay to identify suitable compounds that could have an effect on KIBRA activity. The results of this screening programme are to be expected in the third quarter of 2011. In addition to its numerous patent applications already filed, SYGNIS intends to further extend its patent portfolio for KIBRA based on these results and thus increase its leading position in this field.
The key elements of the sustainable value creation of the Company in the long term, besides the development of AX200 and KIBRA, also include the strategic expansion of a well balanced risk/reward product portfolio, which is to be achieved with our own R&D efforts and by in-licensing or acquisitions.