Kiniksa announces development of KPL-387, updated corporate strategy

Kiniksa (KNSA) Pharmaceuticals announced the development program for KPL-387 in recurrent pericarditis and provided an update on its corporate strategy. KPL-387 is an independently developed monoclonal antibody that binds human interleukin-1 receptor 1, inhibiting the signaling activity of the cytokines interleukin-1alpha and interleukin-1beta. Kiniksa continues to focus development on diseases with unmet need, prioritizing cardiovascular indications. Kiniksa is developing KPL-387, a fully human immunoglobulin G2 monoclonal antibody that binds IL-1R1, inhibiting the signaling of the cytokines IL-1alpha and IL-1beta, in recurrent pericarditis with a target profile of monthly subcutaneous dosing. Kiniksa is conducting a single ascending dose and multiple ascending dose Phase 1 clinical trial of KPL-387 in healthy volunteers. Topline data from the SAD portion of the Phase 1 trial of KPL-387 support potential monthly SC dosing in recurrent pericarditis. Kiniksa has interacted with the U.S. Food and Drug Administration and expects to initiate a Phase 2/3 clinical trial of KPL-387 in recurrent pericarditis in mid-2025, with Phase 2 data expected in the second half of 2026. Kiniksa is advancing KPL-1161, an Fc-modified IgG2 monoclonal antibody that binds IL-1R1, inhibiting the signaling of the cytokines IL-1alpha and IL-1beta, towards clinical development with a target profile of quarterly SC dosing.