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During the congress, E-Posters will be accessible to all participants on the congress website 24/7, as well as in the E-poster stations in the congress center.
Preparing your E-Poster
Please review the E-Poster format requirements carefully when preparing your E-Poster. Should your E-Poster not meet the mentioned requirements, it may not be displayed as described above.
E-Poster Submission Deadline
Please prepare and upload your E-Poster no later than March 14, 2026 11.59PM CET. After this date, you will no longer be able to prepare and upload your E-poster and it will not be displayed and accessible on the congress website.
Please follow the instructions below to input your abstract title.
Abstract titles should be brief and reflect the content of the abstract.
Sefaxersen (RO7434656) is a GalNAc-conjugated antisense oligonucleotide targeting complement factor B (FB) and is under development for the treatment of IgA nephropathy. The objective of this study was to assess the pharmacokinetics, pharmacodynamics, safety and tolerability of sefaxersen in Chinese healthy participants.
This randomized, open-label, parallel-group study (ISRCTN85572126) enrolled 14 healthy participants in a single site in China. Participants were randomized into two treatment arms to receive one dose of sefaxersen 40 mg or 70 mg administered subcutaneously (SC). Participants were followed up for 90 days after administration. The primary endpoint was plasma concentration and derived pharmacokinetic parameters of sefaxersen. Secondary endpoints included change from baseline of plasma FB levels and safety and tolerability of sefaxersen.
Sefaxersen appears to be rapidly absorbed into the systemic circulation after SC administration, with median peak plasma concentration observed 1 to 2 hours after dosing. After reaching peak concentration, mean concentrations of sefaxersen declined in a multiphasic fashion with time, with a fast initial distribution phase and followed by a slower elimination phase. Characterization of the terminal elimination phase yielded a half life of approximately 6 to 7 weeks. Plasma FB level decreased rapidly in both sefaxersen 40 mg and 70 mg arms, reaching a nadir on Day 22 that was sustained through Day 90. The mean percent change from baseline in FB level was 49.4% in 40 mg arm and 65.8% in 70 mg arm on Day 22, and it was 23.1% in 40 mg arm and 33.6% in 70 mg arm on Day 90. Five of 7 participants (71.4%) who received 40 mg reported 13 treatment-emergent adverse events (TEAEs) and 4 of 7 participants (57.1%) who received 70 mg reported 7 TEAEs. All TEAEs were grade 1 (mild) or grade 2 (moderate) in severity and none were severe. No serious TEAEs were reported. No clinically significant changes from baseline were observed in vital signs, electrocardiogram, or laboratory tests in either treatment arm.
The exposure of sefaxersen in Chinese healthy participants, as measured by Cmax and AUC, was similar to the global phase 1 study. A single dose of sefaxersen 40 mg or 70 mg reduced plasma FB level for up to 90 days, with the 70 mg dose resulting in a greater degree of reduction in plasma FB level. Sefaxersen was found to be generally safe and well tolerated by the study participants.
