Single- And Multiple-Ascending Dose Studies Of DS-2325a, A KLK5 Inhibitor For The Treatment Of Netherton Syndrome

    P. Zou, Arvind Mohan, Anli Liu, Chun-Chih Hsu, Maxine Brown, Sarah Grossman, Sarah Urbina, S. Perez-Carrillo, Kazumi Fujimoto, E. Suzuki, H. Yano, H. Takahashi, J. Levy, A. Hand, G. Senaldi
    TLDR DS-2325a is safe and well-tolerated, supporting further development for Netherton Syndrome treatment.
    The studies evaluated the safety, pharmacokinetics, and immunogenicity of DS-2325a, a KLK5 inhibitor, in 88 healthy volunteers through single and multiple ascending dose trials. DS-2325a was generally safe and well tolerated, with mostly mild and non-serious treatment emergent adverse events, primarily injection site reactions, which resolved without intervention. The drug showed favorable pharmacokinetic properties, with proportional absorption after subcutaneous dosing and minimal urinary excretion. No anti-drug antibodies were detected, supporting the further development of DS-2325a for treating Netherton Syndrome.
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