PEGCETACOPLAN FOR 52 WEEKS MAINTAINS PROTEINURIA REDUCTION AND EGFR STABILIZATION FOR PEDIATRIC PATIENTS: PHASE 3 VALIANT SUBGROUP ANALYSIS

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Abstract Title *

PEGCETACOPLAN FOR 52 WEEKS MAINTAINS PROTEINURIA REDUCTION AND EGFR STABILIZATION FOR PEDIATRIC PATIENTS: PHASE 3 VALIANT SUBGROUP ANALYSIS

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Co-author 1

Larry A Greenbaum lgreen6@emory.edu Emory School of Medicine and Children’s Healthcare of Atlanta Emory School of Medicine and Children’s Healthcare of Atlanta Atlanta United States *

Co-author 2

Carla M Nester carla-nester@uiowa.edu University of Iowa Stead Family Children’s Hospital Iowa City United States -

Co-author 3

Gema Ariceta gema.ariceta@vallhebron.cat Hospital Vall d'Hebron Hospital Vall d'Hebron Barcelona Spain -

Co-author 4

Bradley P Dixon bradley.dixon@childrenscolorado.org University of Colorado School of Medicine University of Colorado School of Medicine Aurora United States -

Co-author 5

Yael Borovitz yaelbo2@clalit.org.il Schneider Children’s Medical Center of Israel Schneider Children’s Medical Center of Israel Petah-Tikva Israel -

Co-author 6

Christoph Licht christoph.licht@sickkids.ca The Hospital for Sick Children and University of Toronto The Hospital for Sick Children and University of Toronto Toronto Canada -

Co-author 7

Antonio Mastrangelo antonio.mastrangelo@policlinico.mi.it IRCCS Ca' Granda Ospedale Maggiore Policlinico IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy -

Co-author 8

Nabil Melhem nabil.melhem@gstt.nhs.uk Evelina London Children's Hospital Guy’s and St Thomas' NHS Foundation Trust London United Kingdom -

Co-author 9

Naoya Fujita fugita708@hkg.odn.ne.jp Aichi Children's Health and Medical Center Aichi Children's Health and Medical Center Aichi Japan -

Co-author 10

Nicole CAJ Van de Kar nicole.vandekar@radboudumc.nl Radboudumc Amalia Children's Hospital Radboudumc Amalia Children's Hospital Nijmegen Netherlands -

Co-author 11

Dean Wallace dean.wallace@mft.nhs.uk Royal Manchester Children’s Hospital Royal Manchester Children’s Hospital Manchester United Kingdom -

Co-author 12

Anwesha Mukherjee anwesha.mukherjee@apellis.com Apellis Pharmaceuticals Inc Apellis Pharmaceuticals Inc Waltham United States -

Co-author 13

Elena Surova elena.surova@sobi.com Swedish Orphan Biovitrum AB Swedish Orphan Biovitrum AB Stockholm Sweden -

Co-author 14

Johan Szamosi johan.szamosi@sobi.com Swedish Orphan Biovitrum AB Swedish Orphan Biovitrum AB Stockholm Sweden -

Co-author 15

Marina Vivarelli marina.vivarelli@opbg.net Bambino Gesù Children's Hospital Bambino Gesù Children's Hospital, IRCCS Rome Italy -

Introduction

C3 glomerulopathy (C3G) and primary immune-complex mediated membranoproliferative glomerulonephritis (IC-MPGN) are often diagnosed in childhood. In the 26-week randomized controlled period (RCP) of VALIANT (phase 3; NCT05067127), pegcetacoplan (C3/C3b inhibitor) for C3G and primary IC-MPGN led to significant proteinuria reduction vs placebo and estimated glomerular filtration rate (eGFR) stabilization for adolescents (12–17 years) and the overall population. In the following 26-week open-label period (OLP), all patients received pegcetacoplan.

Methods

28 and 27 adolescents were randomized to pegcetacoplan or placebo, respectively; 27 and 25 adolescents, respectively, entered the OLP. Efficacy end points included changes from baseline in proteinuria (measured as urine protein-to-creatinine ratio [UPCR]) and eGFR. Treatment-emergent adverse events were noted.

Results

Adolescents who received pegcetacoplan for 52 weeks had sustained proteinuria decrease (mean [95% CI] UPCR change from baseline: week 26, –73.6% [–83.1, –58.6]; week 52, –71.8% [–82.9, –53.6]) (Figure). Results for placebo-to-pegcetacoplan patients in the OLP were consistent with proteinuria decreases in the RCP for the pegcetacoplan group. Adolescents achieved stable eGFR throughout VALIANT (least squares mean [SE] change from baseline: week 26, +0.7 [3.6] mL/min/1.73 m2; week 52, +3.2 [4.1] mL/min/1.73 m2). No new safety signals were identified.

Conclusion

Clinical efficacy of 52 weeks of pegcetacoplan treatment for adolescents was consistent with the overall population of VALIANT, confirming its sustained benefit in broad patient populations.

Previously presented at ASN 2025 (Journal of the American Society of Nephrology)

Kewords