CPV-104 / Eleva - LARVOL DELTA

Essential One: A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy (clinicaltrials.gov) - P1 | N=39 | Recruiting | Sponsor: eleva GmbH | Trial completion date: Jun 2026 ➔ Nov 2026 | Trial primary completion date: Jun 2026 ➔ Nov 2026

First-in-human • Trial completion date • Trial primary completion date • Complement-mediated Rare Disorders • Glomerulonephritis

Moss-derived recombinant Factor H, CPV-104, effectively antagonizes alternative pathway C3/C5 convertases stabilization by NeFs from patients with primary C3 glomerulopathy. (PubMed, Front Immunol) - "CPV-104 effectively limits both stabilization and formation of AP C3 convertases in NeF-positive C3G, demonstrating superior functional activity compared with sd-FH. By restoring physiological AP regulation rather than broadly inhibiting complement activation, CPV-104 represents a promising and potentially safer therapeutic strategy for NeF-driven C3G and warrants further clinical investigation."

Journal • Complement-mediated Rare Disorders • Glomerulonephritis • Nephrology • Renal Disease

Essential One: A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy (clinicaltrials.gov) - P1 | N=39 | Recruiting | Sponsor: eleva GmbH

First-in-human • Trial initiation date • Complement-mediated Rare Disorders • Glomerulonephritis

Essential One: A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy (clinicaltrials.gov) - P1 | N=39 | Recruiting | Sponsor: eleva GmbH

First-in-human • New P1 trial • Complement-mediated Rare Disorders • Glomerulonephritis

CPV-104-101: A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients with C3-Glomerulopathy (clinicaltrialsregister.eu) - P1 | N=58 | Recruiting | Sponsor: Eleva GmbH

New P1 trial • Complement-mediated Rare Disorders • Glomerulonephritis

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 (GlobeNewswire) - "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."

Trial status • Renal Disease

Moss-derived human complement factor H modulates retinal immune response and attenuates retinal degeneration. (PubMed, J Neuroinflammation) - "Modulating the alternative complement pathway using moss-derived recombinant human full-length CFH variant CPV-101 and CPV-104 counter-regulate gliosis and attenuates light-induced retinal degeneration, highlighting a promising concept for the treatment of AMD patients."

Journal • Age-related Macular Degeneration • Ophthalmology

Effective long-term treatment with moss-produced factor H by overcoming the antibody response in a mouse model of C3G. (PubMed, Front Immunol) - "Complement-associated disorders are caused by the dysregulation and disbalance of the complement system, especially excessive activation. Repeated CPV-104 administration was able to lastingly resolve C3 deposits, offering additional rationale for the clinical testing of CPV-104 in human C3G patients. Moreover, our novel dual-depletion method has the potential for adaptation to different mouse models, allowing the testing of multiple doses of other therapeutic proteins."

Journal • Preclinical • Complement-mediated Rare Disorders • Glomerulonephritis • CD20 • CD4

Moss-Produced Human Factor H (CPV-104): Pioneering Rebalancing Therapies for Kidney Complement Disorders (KIDNEY WEEK 2024) - "By optimizing dosing intervals and exploring s.c. administration, FH availability was significantly improved in conjunction with sustained reduction of glomerular C3 deposits in preclinical models. These findings provide valuable insights into the clinical translation of CPV-104 as a new therapeutic strategy for complement-mediated renal diseases, enabling physiological complement functionality."

Complement-mediated Rare Disorders • Renal Disease

Moss-produced human complement factor H with modified glycans has an extended half-life and improved biological activity. (PubMed, Front Immunol) - "Most drugs that target the complement system are designed to inhibit the complement pathway at either the proximal or terminal levels. Furthermore, CPV-104 showed comparable functionality to serum-derived FH in vitro, as well as similar performance in ex vivo assays involving samples from patients with atypical hemolytic uremic syndrome, C3 glomerulopathy and paroxysomal nocturnal hematuria. CPV-104 - the human FH analog expressed in moss - will therefore allow the treatment of complement-associated human diseases by rebalancing instead of inhibiting the complement cascade."

Journal • Atypical Hemolytic Uremic Syndrome • Complement-mediated Rare Disorders • Glomerulonephritis • Nephrology