Sobi to present new data on pegcetacoplan at ERA 2026

Sobi® today announced that new data from the pegcetacoplan clinical development programme and related research in C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) will be presented at the 63rd Congress of the European Renal Association (ERA), taking place from 3 - 6 June 2026 in Glasgow, UK. Presentations will be made in collaboration with Apellis Pharmaceuticals (now part of Biogen).

The presentations include new analyses from the pivotal Phase 3 VALIANT study and its long-term extension VALE study evaluating pegcetacoplan in patients with C3G and primary IC-MPGN, including data on treatment response, disease chronicity, long-term clinical benefit, safety and tolerability. Additional presentations will explore real-world disease burden and epidemiology.

“As the body of evidence continues to grow, we are deepening our understanding of C3G and primary IC-MPGN and the burden these rare and serious kidney diseases place on patients,” said Lydia Abad-Franch, MD, Head of R&D and Medical Affairs, and Chief Medical Officer at Sobi. “The data being presented at ERA 2026 continue to build the evidence supporting the sustained efficacy and well-characterised safety profile of pegcetacoplan in patients with C3G and primary IC-MPGN.”

About C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN)
C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately 50% of people living with C3G or primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or dialysis therapy.1-3 Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence.4 The diseases are estimated to affect 5,000 people in the United States and up to 8,000 in Europe.5 

About the VALIANT study

The VALIANT Phase 3 study (NCT05067127) was a randomised, placebo-controlled, double-blinded, multi-centre study designed to evaluate pegcetacoplan efficacy and safety in 124 patients who are 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. Study participants were randomised to receive 1080 mg of pegcetacoplan or placebo twice weekly for 26 weeks. Following this 26-week randomised controlled period, patients were able to proceed to a 26-week open-label phase in which all patients receive pegcetacoplan6. The primary endpoint of the study was the log transformed ratio of urine protein-to-creatinine ratio (uPCR) at Week 26 compared to baseline.

All patients who completed the VALIANT study have now enrolled in the VALE long-term extension study.

About Aspaveli®/Empaveli® (pegcetacoplan)

Aspaveli/Empaveli (pegcetacoplan) is a targeted C3 and C3b therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. It is the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older approved in the United States, European Union, and other countries globally. Aspaveli/Empaveli is also approved for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) in the United States, European Union, and other countries globally.

About the Sobi® and Apellis (now part of Biogen) collaboration

Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialisation rights for systemic pegcetacoplan. Apellis has exclusive U.S. commercialisation rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.

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 2,000 employees across Europe, North America, the Middle East, Asia and Australia. In 2025, revenue amounted to SEK 28 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

Contacts

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References

1. Smith RJH, et al. Nat Rev Nephrol. 2019;15(3):129-143.

2. Servais A, et al. Kidney Int. 2012;82(4):454-464.

3. Zand L, et al. J Am Soc Nephrol. 2014;25(5):1110-1117.

4. Tarragón, B, et al. Clin J Am Soc Nephrol 2024; 19(8)1005-1015.

5. Data on file using literature consensus.

6. Fakhouri F, et al. N Engl J Med 2025;393:2210-2220