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 Poster presentation perspective on the care pathway and unmet Session: Glomerular & tubulo-interstitial diseases needs in patients with C3 glomerulopathy (C3G) and primary immune complex Room: XWall 1 Mozart Symphony No. 40 membranoproliferative Date: 5 June 2025 glomerulonephritis (IC-MPGN) in the US and Europe. Time: 13:12 CEST Presenter: Carly Rich Pegcetacoplan treatment effect in patients with Oral presentation nephrotic range proteinuria: results from the Session: FC 14: About C3 and IgA Glomerulonephritis VALIANT Phase 3 study in patients with C3G or Room: Hall F1 Primary (Idiopathic) IC-MPGN Date: 6 June 2025 Presenter: Antonio Mastrangelo Time: 08:15 CEST Targeted treatment with pegcetacoplan for Oral presentation adolescents with C3G or Primary (Idiopathic) IC- Session: FC 14: About C3 and IgA Glomerulonephritis MPGN in the VALIANT Phase 3 trial Room: Hall F1 Presenter: Antonio Mastrangelo Date: 6 June 2025 Time: 08:30 CEST Pegcetacoplan demonstrates clinically significant Oral presentation responses in C3G and Primary (Idiopathic) Session: FC 14: About C3 and IgA Glomerulonephritis IC-MPGN patients with or without concomitant Room: Hall F1 immunosuppression in VALIANT Date: 6 June 2025 Presenter: David Kavanagh Time: 09:30 CEST Association between proteinuria and clinically Poster Presentation meaningful endpoints in patients with C3G / IC- Session: Chronic Kidney Disease MPGN: a Delphi consensus of European experts Room: Strauss Wiener Blut Presenter: Fernando Caravaca-Fontán Date: 6 June 2025 Time: 13:06 CEST Pegcetacoplan for C3G and primary (idiopathic) IC- Oral presentation MPGN: 52-week results from the phase 3 VALIANT Session: Innovative Kidney Trials trial show sustained efficacy Room: The Square Presenter: Fadi Fakhouri Date: 6 June 2025 Time: 15:00 CEST Targeted Treatment with Pegcetacoplan for post- Focused Oral presentation Transplant Recurrent C3G or Primary (idiopathic) Session: Glomerular & tubulo-interstitial diseases IC-MPGN in the VALIANT Phase 3 Trial Room: Focused Oral Room 3 Presenter: Michiel Oosterveld Date: 6 June 2025 Time: 15:54 CEST Pegcetacoplan Treatment appears to halt disease Focused Oral presentation progression in C3G and Primary (Idiopathic) Session: Glomerular & tubulo-interstitial diseases IC-MPGN patients: results from the Phase 3 VALIANT study Room: Focused Oral Room 3 Presenter: Daniel Gale 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 [https://c212.net/c/link/?t=0&l=en&o=4442073-1&h=3976375084&u=https%3A%2F%2Flinkprotect.cudasvc.com%2Furl%3Fa%3Dhttps%253a%252f%252fwww.sobi.com%252fen%26c%3DE%2C1%2CaFhyF1D7ejcoH3UvyRCBlI022OpaxLPytS-Qr07QIO9c2OorvVpGqQR41jcs7LZg5Gtj4cEHoGVvUingiyOE4f0Kisrsm6iOHl7rjROvvQLGzfP_eKel0WIrsVjN%26typo%3D1&a=sobi.com] and LinkedIn [https://c212.net/c/link/?t=0&l=en&o=4442073-1&h=3814186482&u=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fsobi%2F&a=LinkedIn], BlueSkyX [https://c212.net/c/link/?t=0&l=en&o=4442073-1&h=2613218989&u=https%3A%2F%2Fx.com%2FSobiNephrology&a=BlueSkyX]
Contacts
For details on how to contact the Sobi Investor Relations Team, please click here [https://c212.net/c/link/?t=0&l=en&o=4442073-1&h=2322749890&u=https%3A%2F%2Fwww.sobi.com%2Fen%2Finvestors&a=here]. For Sobi Media contacts, click here [https://c212.net/c/link/?t=0&l=en&o=4442073-1&h=1385819750&u=https%3A%2F%2Fwww.sobi.com%2Fen%2Fmedia&a=here].
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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 [https://c212.net/c/link/?t=0&l=en&o=4442073-1&h=373535004&u=https%3A%2F%2Fnews.cision.com%2Fswedish-orphan-biovitrum-ab%2Fr%2Fsobi-showcases-breadth-of-data-in-c3g-primary-ic-mpgn-at-era-2025%2Cc4158688&a=https%3A%2F%2Fnews.cision.com%2Fswedish-orphan-biovitrum-ab%2Fr%2Fsobi-showcases-breadth-of-data-in-c3g-primary-ic-mpgn-at-era-2025%2Cc4158688]
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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