Eleva Begins Human Trials of Factor H Treatment for C3 Glomerulopathy “`

The first human trial of CPV-104, Eleva’s primary drug candidate (Factor H), represents a significant advancement in the company’s drug development efforts and its commitment to providing innovative treatments to patients.

Freiburg im Breisgau, Germany, July 7, 2025 – Eleva, a company focused on identifying and creating previously inaccessible biologics utilizing a cutting-edge technology platform, has announced the commencement of its Phase 1 clinical trial. This trial will assess the safety and tolerability of Eleva’s Factor H (CPV-104) program in individuals with C3-Glomerulopathy (C3G). The initial phase of the study will involve administering single-ascending doses of CPV-104 to healthy volunteers to evaluate its effects.

Björn Cochlovius, Ph.D., Chief Executive Officer of Eleva, stated, “Today’s announcement marks a significant milestone as our second proprietary program enters clinical trials, a testament to our organizational capabilities. Our Factor H biological therapy platform is gaining increasing recognition among clinicians and potential partners. We are committed to enhancing the value of this program, initially focusing on C3G, with dry AMD as a secondary target, and potentially exploring other indications in the future. We aim to establish a robust infrastructure to support its successful clinical development.”

Dr. Martin Bauer, Chief Medical Officer of Eleva, commented, “We are excited to advance our Factor H molecule into a first-in-human study to assess its safety, tolerability, and pharmacokinetics for future clinical trials. I would like to express my gratitude to all Eleva team members and our clinical partners for their ongoing dedication and commitment in achieving this milestone.”

C3G is a rare kidney disease resulting from irregularities in the complement system regulation, specifically the alternative pathway of the complement cascade, a crucial element of the body’s immune response. Naturally occurring complement regulators like Factor H offer a therapeutic strategy to restore equilibrium within the complement system and have demonstrated therapeutic promise across various indications. Recent preclinical data publications highlight Factor H (CPV-104)’s ability to function as a functional analogue of human Factor H, promote the normalization of serum C3 levels, and facilitate the rapid breakdown of C3 deposits in the kidney. The program has been granted Orphan Drug Designation in the European Union for C3G, and Eleva is also investigating its potential in dry AMD as a secondary indication.

ABOUT ELEVA
Eleva is a biopharmaceutical company in the clinical stage, dedicated to discovering and developing innovative biological therapeutics that were previously unattainable. Eleva’s groundbreaking moss-based technology platform enables the production of human proteins at GMP scale, offering significant therapeutic potential that other platforms cannot match. The company’s proprietary pipeline encompasses candidates for complement disorders and enzyme replacement therapies. The leading program, Factor H (CPV-104), a recombinant human complement Factor H, has progressed to Phase 1/2 clinical studies for the treatment of C3 Glomerulopathy (C3G). An intravitreal formulation of the candidate is in the advanced preclinical stage for treating dry AMD. The company’s aGal (RPV-001) program has successfully completed a Phase 1b single-dose clinical trial for Fabry disease.

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