The most advanced clinical product, SM101, is a soluble Fc gamma receptor IIB (sFcγRIIB), which competes with FcγRs expressed on immune cells for pathogenic immune complexes. Interference at this early stage of the immune reaction prevents the triggering of the cascade that results in inflammation and tissue destruction. In addition to immune complex competition, SM101 interferes with the formation of memory/plasma cells that are causative for the formation of new pathogenic antibodies.
This dual mode of action strongly suggests SM101’s potential for the treatment of different autoimmune diseases. SM101 has been extensively profiled in in-vitro, ex-vivo and in-vivo experiments in order to confirm its mechanisms of action in a broad range of preclinical studies. SM101 was also tested in a range of animal disease models with a predictive value for future clinical outcome in patients.
To date, SM101 has been tested in ITP patients and has shown excellent safety data and long lasting pharmacodynamic effects. SM101 is initially being developed to treat ITP and SLE. This two-tiered development strategy will provide fast Proof-of-Concept in ITP. Studies in SLE can be considered as indicative for SM101´s potential in rheumatoid diseases. At the same time both lead indications are commercially very attractive. This approach will enable the future development of SM101 in other indications such as RA.