“Patient safety remains our highest priority,” said Mitchell H. Gold, M.D., Executive Chairman and Chief Executive Officer of Alpine. “We have determined it is in the best interest of all patients to terminate enrollment in the davoceticept studies and we will continue to work with the U.S. Food and Drug Administration, Merck, the study Safety Monitoring Committee, and the study investigators to further understand this important safety issue. Davoceticept has shown encouraging signs of clinical activity and it is unfortunate we have not yet been able to identify a safe dose regimen for the combination with pembrolizumab. We will now prioritize the bulk of our development resources towards advancing our lead wholly-owned program ALPN-303 in multiple autoimmune and inflammatory indications, as well as acazicolcept in SLE in collaboration with AbbVie.”
