Kira Receives FDA Clearance of IND Application for Phase 2 Evaluation in Systemic Lupus

 

Phase 1 supporting data indicated an encouraging profile and confirmed the dual mechanism of action achieved through targeting both the alternative and terminal complement pathways  Kira Pharmaceuticals, a global biotechnology company pioneering transformational complement therapies to treat immune-mediated diseases, announced today that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for KP104, a first-in-class bifunctional biologic that selectively and synergistically targets the alternative and terminal complement pathways. The Phase 2 trial will evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with systemic lupus erythematosus associated thrombotic microangiopathy (SLE-TMA) in the US, China, and Australia. The IND was supported by Phase 1 data (SYNERGY-1 Study), which demonstrated proof-of-mechanism for KP104 on both the terminal and alternative complement pathways and showed an encouraging profile for the Phase 2 study in SLE-TMA. https://www.biospace.com/article/releases/kira-pharmaceuticals-receives-fda-clearance-of-ind-application-for-phase-2-evaluation-of-kp104-in-systemic-lupus-erythematosus-associated-thrombotic-microangiopathy-sle-tma-/?keywords=kira