Kira Pharmaceuticals, a Sino-US biotech company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical study of KP104. The study will assess 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.
About KP104
KP104 is a first-in-class bifunctional biologic designed to simultaneously and selectively block both the alternative and terminal complement pathways. This dual-action mechanism provides a powerful and synergistic approach to targeting validated drivers of complement-mediated diseases. Kira has successfully completed a Phase 1 first-in-human (FIH) study of KP104, demonstrating clinical proof-of-mechanism (POM) for this innovative biologic.
Advancing to Phase II Trials
KP104 is now advancing to Phase II proof-of-concept (POC) trials across multiple renal disease and hematologic indications. The drug has also been granted Orphan Drug Designation status by the FDA for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). KP104 is engineered to have an extended half-life and potency, with a formulation suitable for both intravenous and subcutaneous administrations.-Fineline Info & Tech
