Eleva advances CPV-104 into Phase 1b clinical testing in patients with C3G, following the successful completion of single ascending dose evaluation in healthy volunteers

• CPV-104 is the only recombinant Factor H in clinical development and has received EU Orphan Drug Designation for C3G
• Eleva successfully completed the Single Ascending Dose part of the First-in-Human clinical trial evaluating CPV-104 in healthy volunteers
• The Safety Review Committee endorsed the study with no safety concerns identified across all four dose cohorts
• 18 patients with C3G will receive now CPV-104 in a Multiple Ascending Dose regimen administered over a four-week period
• Recombinant human Factor H is the second clinical-stage biological candidate to be manufactured using Eleva’s proprietary moss-based GMP-scale platform

Freiburg im Breisgau, Germany – October 21, 2025 – Eleva, a pioneer in discovering and developing previously inaccessible biologics based on its breakthrough moss technology platform, today announced that CPV-104, a recombinant human complement Factor H, has advanced into evaluation in patients with C3 glomerulopathy (C3G), a rare renal disease caused by dysregulation of the complement system. This follows the successful completion of the single ascending dose (SAD) part of its First in Human clinical trial investigating CPV-104 in 21 healthy volunteers. The study, designed to evaluate the safety, tolerability, and pharmacokinetics of CPV-104, included four dose cohorts and concluded with no safety concerns.

"We are highly encouraged by the favorable safety profile observed in healthy volunteers. As we initiate patient cohorts now, we look forward to generating solid data to demonstrate the potential of CPV-104 to modify the course of complement mediated kidney diseases. This marks an important step toward delivering a targeted therapy for C3G, where treatment options remain severely limited” said Dr. Martin Bauer, Chief Medical Officer of Eleva.

Following a comprehensive review of the SAD data, the Safety Review Committee has unanimously agreed to proceed with the multiple ascending dose part of the study. The MAD study will include three dose cohorts and will be conducted in patients diagnosed with C3G to further assess the safety profile of CPV-104 in the targeted population.

“The successful completion of the SAD part is a significant milestone for CPV-104 and further validates our moss-based manufacturing platform,” added Björn Cochlovius, Ph.D., Chief Executive Officer of Eleva. “Factor H is difficult to manufacture at scale with traditional CHO and yeast processes. Being able to produce these complex proteins at scale underscores our differentiated position in biologics manufacturing.”

Preclinical studies have shown CPV-104 to be functionally equivalent to endogenous human Factor H, with the ability to normalize serum C3 levels and promote clearance of pathogenic complement deposits. The program has received Orphan Drug Designation in the European Union for the treatment of C3G.

Factor H is a key complement control protein that cannot be manufactured at scale using other GMP-scale production platforms, such as CHO or yeast. CPV-104 is now the only Factor H therapeutic candidate in the clinic and one of the first two clinical-stage biologics to be manufactured using Eleva’s proprietary moss-based GMP-scale production platform. Eleva’s moss-based platform enables precise, scalable, and sustainable production of a wide variety of complex proteins, underscoring Eleva’s position as a pioneer in next-generation biologics manufacturing. The other therapeutic candidate from the company is aGal (RPV-001), a-galactosidase (aGal) enzyme, which has successfully completed Phase 1b development for Fabry disease.

About Eleva

Eleva is a clinical-stage biopharmaceutical company discovering and developing previously inaccessible biological therapeutics. Eleva’s disruptive moss-based technology platform enables GMP-scale manufacturing of human proteins with tremendous therapeutic potential that have been too challenging to manufacture using other approaches. The company’s proprietary pipeline includes candidates for complement disorders and enzyme replacement therapies. The lead program, CPV-104 recombinant human complement Factor H, is in Phase 1b testing to treat C3 Glomerulopathy (C3G). An intravitreal formulation of the candidate is in late preclinical development to treat dry AMD. The company’s aGal (RPV-001) program has completed a positive Phase 1b single-dose clinical trial to treat Fabry disease.

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