Sino-US biotech Kira Pharmaceuticals has announced receiving approvals from China’s National Medical Products Administration (NMPA) and the Australian Therapeutic Goods Administration (TGA) to conduct a Phase II clinical study assessing the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of its KP104 pipeline candidate. This marks a significant milestone in the development of KP104, positioning Kira Pharmaceuticals to further explore its potential as a first-in-class bi-functional biologic.
Drug Profile and Mechanism of Action
KP104 is a potential global first-in-class bi-functional biologic described as the world’s only drug to simultaneously block the upstream Alternative Pathway (Factor H) and downstream Terminal Pathway (C5). The drug is under development for complement-mediated diseases where single-target C5 or C3 inhibitors alone are inadequate.
Clinical Development and Future Prospects
KP104 is entering Phase II proof-of-concept trials in various renal diseases and hematologic indications, including IgAN, C3 glomerulopathy, thrombotic microangiopathies secondary to systemic lupus erythematosus (SLE-TMA), and paroxysmal nocturnal hemoglobinuria (PNH). The drug has won Orphan Drug Designation status by the US FDA for the treatment of PNH. These approvals from the NMPA and TGA position Kira Pharmaceuticals to advance KP104 through clinical development, addressing significant unmet medical needs in complement-mediated diseases.-Fineline Info & Tech
