- CPV-104 is the sole recombinant Factor H undergoing clinical trials and has been granted Orphan Drug Designation by the EU for C3G
- Eleva has successfully concluded the Single Ascending Dose segment of its First-in-Human clinical trial, which assessed CPV-104 in healthy participants
- The Safety Review Committee approved the study, having found no safety issues across any of the four dose groups
- Eighteen C3G patients are now slated to receive CPV-104 through a Multiple Ascending Dose regimen, administered over four weeks
- Recombinant human Factor H represents the second clinical-stage biological candidate produced using Eleva’s patented moss-based GMP-scale manufacturing platform
Freiburg im Breisgau, Germany – October 21, 2025 – Eleva, a leader in identifying and developing previously unattainable biologics leveraging its innovative moss technology platform, today declared that CPV-104, a recombinant human complement Factor H, has progressed to patient evaluation for C3 glomerulopathy (C3G), a rare kidney disorder stemming from complement system dysregulation. This advancement comes after the successful conclusion of the single ascending dose (SAD) portion of its First-in-Human clinical trial, which examined CPV-104 in 21 healthy volunteers. The trial, structured to assess CPV-104’s safety, tolerability, and pharmacokinetics, involved four dose groups and reported no safety issues.
“The encouraging safety profile observed in healthy volunteers is very positive for us. As we begin patient cohorts, we aim to produce robust data showcasing CPV-104’s potential to alter the progression of complement-mediated kidney diseases. This signifies a crucial move towards providing a targeted treatment for C3G, a condition with severely restricted therapeutic choices,” stated Dr. Martin Bauer, Eleva’s Chief Medical Officer.
After a thorough review of the SAD findings, the Safety Review Committee unanimously endorsed moving forward with the multiple ascending dose segment of the trial. The MAD study will encompass three dose groups and will be carried out in patients diagnosed with C3G to further evaluate CPV-104’s safety profile within the specific patient population.
“The successful conclusion of the SAD phase represents a major achievement for CPV-104 and reinforces the efficacy of our moss-based manufacturing platform,” commented Björn Cochlovius, Ph.D., Eleva’s Chief Executive Officer. “Factor H presents manufacturing challenges at scale using conventional CHO and yeast processes. Our capacity to produce such complex proteins at scale highlights our unique standing in biologics manufacturing.”
Preclinical investigations have demonstrated CPV-104’s functional equivalence to endogenous human Factor H, capable of normalizing serum C3 levels and facilitating the removal of pathogenic complement deposits. The initiative has secured Orphan Drug Designation in the European Union for addressing C3G.
Factor H, a crucial complement control protein, cannot be mass-produced using alternative GMP-scale production systems, including CHO or yeast. CPV-104 is currently the sole therapeutic candidate in clinical trials and stands as one of the initial two clinical-stage biologics produced via Eleva’s proprietary moss-based GMP-scale manufacturing platform. Eleva’s moss-based system facilitates the accurate, scalable, and sustainable production of a diverse range of complex proteins, cementing Eleva’s role as an innovator in next-generation biologics manufacturing. The company’s other therapeutic candidate is aGal (RPV-001), an a-galactosidase enzyme, which has successfully finished Phase 1b development for Fabry disease.
About Eleva
Eleva is a biopharmaceutical firm in the clinical stage, focused on identifying and advancing biological therapeutics that were previously unattainable. Eleva’s groundbreaking moss-based technology platform allows for the GMP-scale production of human proteins holding significant therapeutic promise, which have historically posed manufacturing difficulties via other methods. The company’s proprietary portfolio features candidates for complement disorders and enzyme replacement therapies. Its primary program, CPV-104, a recombinant human complement Factor H, is undergoing Phase 1b trials for the treatment of C3 Glomerulopathy (C3G). An intravitreal version of this candidate is in late preclinical development for addressing dry AMD. The company’s aGal (RPV-001) program has successfully concluded a Phase 1b single-dose clinical trial for Fabry disease.
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