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 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) 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) 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) 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
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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 |
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