Eleva, a clinical-stage biopharmaceutical company, has achieved a significant milestone by administering the first dose of its Factor H biological treatment CPV-104 to healthy volunteers in a Phase 1 clinical study for C3 Glomerulopathy (C3G). The first-in-human administration marks a major advancement for the company's lead compound and represents progress toward bringing a new treatment option to patients with this rare kidney disease.
Clinical Trial Design and Objectives
The Phase 1 clinical study is investigating single-ascending doses of CPV-104 in healthy volunteers as part of its initial phase. The study aims to evaluate the safety, tolerability, and pharmacokinetics of the therapy to inform further clinical development.
"We are thrilled to advance our Factor H molecule into a first-in-human study to evaluate the safety and tolerability and pharmacokinetics for further clinical studies," commented Dr. Martin Bauer, Chief Medical Officer of Eleva.
Targeting Complement System Dysfunction
C3G represents a rare renal disease caused by the abnormal regulation of the complement system, particularly the alternative pathway of the complement cascade, which forms a central part of the body's immune defense. Naturally occurring complement regulators such as Factor H offer a therapeutic approach to help restore balance within the complement system and have shown therapeutic potential in a range of indications.
CPV-104 is a recombinant human complement Factor H designed to address the underlying complement dysregulation that drives C3G pathology. The therapy has received Orphan Drug Designation in the European Union for C3G, recognizing both the unmet medical need and the therapeutic potential of this approach.
Preclinical Evidence Supporting Clinical Development
Preclinical data sets recently published in Frontiers in Immunology provided strong scientific rationale for advancing CPV-104 into human trials. The studies demonstrated CPV-104's ability to act as a functional analogue of human Factor H, support normalization of serum C3 levels, and lead to rapid degradation of C3 deposits in the kidney.
These findings suggest that CPV-104 could address the fundamental pathophysiology of C3G by restoring proper complement regulation and reducing the pathological complement activation that characterizes the disease.
Expanding Pipeline and Platform Capabilities
This clinical milestone represents Eleva's second proprietary program to advance into clinical trials, demonstrating the company's growing capabilities in developing previously inaccessible biologics. "Today's news marks our second proprietary program advancing into clinical trials, which is a great achievement from an organizational standpoint," commented Björn Cochlovius, Ph.D., Chief Executive Officer of Eleva.
The company's moss-based technology platform enables GMP-scale manufacturing of human proteins with therapeutic potential that other platforms cannot achieve. Beyond C3G, Eleva is also pursuing CPV-104 for dry age-related macular degeneration (AMD) as a second indication, with an intravitreal formulation currently in late preclinical development.
Strategic Development Approach
Eleva's Factor H biological therapy platform continues to gain visibility among clinicians and potential partners. The company plans to continue adding value to the C3G program while building infrastructure for successful clinical development across multiple indications.
"We will continue to add value to this program in C3G as our initial focus, dry AMD as a second indication, and potentially several others down the road, while creating the best infrastructure for its successful clinical development," Cochlovius noted.
The company's broader pipeline includes candidates for complement disorders and enzyme replacement therapies, with the aGal (RPV-001) program having completed a positive Phase 1b single-dose clinical trial to treat Fabry disease.
