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      Sobi Showcases Breadth of data in C3G/primary IC-MPGN at ERA 2025


      News provided by

      Swedish Orphan Biovitrum AB

      04 Jun, 2025, 07:30 GMT

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      STOCKHOLM, June 4, 2025 /PRNewswire/ -- Sobi® (STO: SOBI) will have a strong scientific presence at this year's ERA congress in Vienna (4-7 June) with a total of eight presentations: six oral presentations and two posters. We are proud that two of our abstracts have been recognised in the top 10 abstracts at ERA 2025, as selected by expert reviewers coordinated by the ERA Paper Selection Committee.

      Notably, 52-week results from the open-label-period (OLP) of the VALIANT Phase 3 study will be presented for the first time. This data will be featured in an oral presentation by Professor Fadi Fakhouri (Lausanne University Hospital and University of Lausanne) during the session "Innovative Kidney Trials", on 6 June 2025 at 15:00 CEST.

      The two abstracts selected in the top 10 at the conference both highlight important subgroup results from the randomised-controlled-period (RCP) of the VALIANT Phase 3 study covering the treatment effect of pegcetacoplan at 26 weeks in patients with nephrotic range proteinuria at baseline, and the effect of pegcetacoplan in adolescents at 26 weeks.

      Lydia Abad-Franch, MD, MBA, Head of Research, Development, and Medical Affairs (RDMA), and Chief Medical Officer at Sobi says, "The large number of oral presentations, including one achieving the highest ranking of all ERA abstracts and a second in the top 10, reflects the importance of the data and research outputs being generated from our work aimed at advancing treatments for rare kidney conditions."

      Key data to be presented at ERA 2025

      VALIANT

      A thematic analysis of healthcare provider

      perspective on the care pathway and unmet
      needs in patients with C3 glomerulopathy
      (C3G) and primary immune complex
      membranoproliferative

      glomerulonephritis (IC-MPGN) in the US and Europe.

      Presenter: Carly Rich

      Poster presentation

      Session: Glomerular & tubulo-interstitial diseases

      Room: XWall 1 Mozart Symphony No. 40

      Date: 5 June 2025

      Time: 13:12 CEST

      Pegcetacoplan treatment effect in patients with

      nephrotic range proteinuria: results from the

      VALIANT Phase 3 study in patients with C3G or

      Primary (Idiopathic) IC-MPGN

      Presenter: Antonio Mastrangelo

      Oral presentation

      Session: FC 14: About C3 and IgA Glomerulonephritis

      Room: Hall F1

      Date: 6 June 2025

      Time: 08:15 CEST

      Targeted treatment with pegcetacoplan for

      adolescents with C3G or Primary (Idiopathic) IC-

      MPGN in the VALIANT Phase 3 trial

      Presenter: Antonio Mastrangelo

      Oral presentation

      Session: FC 14: About C3 and IgA Glomerulonephritis

      Room: Hall F1

      Date: 6 June 2025

      Time: 08:30 CEST

      Pegcetacoplan demonstrates clinically significant

      responses in C3G and Primary (Idiopathic)
      IC-MPGN patients with or without concomitant

      immunosuppression in VALIANT

      Presenter: David Kavanagh

      Oral presentation

      Session: FC 14: About C3 and IgA Glomerulonephritis

      Room: Hall F1

      Date: 6 June 2025

      Time: 09:30 CEST

      Association between proteinuria and clinically

      meaningful endpoints in patients with C3G / IC-

      MPGN: a Delphi consensus of European experts

      Presenter: Fernando Caravaca-Fontán

      Poster Presentation

      Session: Chronic Kidney Disease

      Room: Strauss Wiener Blut

      Date: 6 June 2025

      Time: 13:06 CEST

      Pegcetacoplan for C3G and primary (idiopathic) IC-

      MPGN: 52-week results from the phase 3 VALIANT

      trial show sustained efficacy

      Presenter: Fadi Fakhouri

      Oral presentation

      Session: Innovative Kidney Trials

      Room: The Square

      Date: 6 June 2025

      Time: 15:00 CEST

      Targeted Treatment with Pegcetacoplan for post-

      Transplant Recurrent C3G or Primary (idiopathic)
      IC-MPGN in the VALIANT Phase 3 Trial

      Presenter: Michiel Oosterveld

      Focused Oral presentation

      Session: Glomerular & tubulo-interstitial diseases

      Room: Focused Oral Room 3

      Date: 6 June 2025

      Time: 15:54 CEST

      Pegcetacoplan Treatment appears to halt disease

      progression in C3G and Primary (Idiopathic)
      IC-MPGN patients: results from the Phase 3 VALIANT study

      Presenter: Daniel Gale

      Focused Oral presentation

      Session: Glomerular & tubulo-interstitial diseases

      Room: Focused Oral Room 3

      Date: 6 June 2025

      Time: 16:06 CEST

      About the VALIANT Study

      The VALIANT Phase 3 study (NCT05067127) was a randomised, placebo-controlled, double-blinded, multi-centre study evaluating pegcetacoplan efficacy and safety in 124 patients who were 12 years of age and older, with C3G or primary IC-MPGN. It is the largest single trial conducted in these populations and the only study to include adolescent and adult patients, with native and post-transplant kidneys. During the 26-week randomised-controlled-period (RCP) of VALIANT, patients received twice weekly subcutaneous pegcetacoplan or placebo. The RCP was followed by a 26-week open-label period (OLP) in which all patients received pegcetacoplan. The primary endpoint of the study was the log transformed ratio of urine protein-to-creatinine ratio (UPCR) at week 26 compared to baseline.

      About Sobi 

      Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2024, revenue amounted to SEK 26 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at  sobi.com and LinkedIn, BlueSkyX

      Contacts 

      For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here. 

      This information was brought to you by Cision http://news.cision.com

      https://news.cision.com/swedish-orphan-biovitrum-ab/r/sobi-showcases-breadth-of-data-in-c3g-primary-ic-mpgn-at-era-2025,c4158688

      The following files are available for download:

      https://mb.cision.com/Main/14266/4158688/3485482.pdf

      Sobi Showcases Breadth of data at ERA 2025

      Modal title

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