Eleva's CPV-104 Advances to Phase 1b Testing in C3G Patients After Successful Safety Evaluation
核心洞察
Eleva (搜索)'s CPV-104, the only recombinant Factor H (搜索) in clinical development, successfully completed single ascending dose testing in 21 healthy volunteers with no safety concerns across four dose cohorts.
The Safety Review Committee has endorsed progression to multiple ascending dose testing in 18 patients with C3 glomerulopathy (搜索) (C3G (搜索)), a rare kidney disease with limited treatment options.
CPV-104 represents a breakthrough in biologics manufacturing, produced using Eleva (搜索)'s proprietary moss-based platform that enables scalable production of complex proteins previously inaccessible through traditional methods.
Eleva (搜索) announced that CPV-104, a recombinant human complement Factor H (搜索), has advanced into Phase 1b evaluation in patients with C3 glomerulopathy (搜索) (C3G (搜索)) following successful completion of single ascending dose testing in healthy volunteers. The rare renal disease, caused by dysregulation of the complement system (搜索), currently has severely limited treatment options.
Successful Safety Profile Enables Patient Testing
The First-in-Human clinical trial evaluated CPV-104 in 21 healthy volunteers across four dose cohorts, designed to assess safety, tolerability, and pharmacokinetics. The Safety Review Committee unanimously endorsed progression to the multiple ascending dose (MAD) phase after identifying no safety concerns throughout the study.
"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," said Dr. Martin Bauer, Chief Medical Officer of Eleva (搜索).
The MAD study will include three dose cohorts conducted in patients diagnosed with C3G (搜索), with 18 patients receiving CPV-104 in a regimen administered over a four-week period to further assess the safety profile in the targeted population.
Breakthrough Manufacturing Platform
CPV-104 represents the only Factor H (搜索) therapeutic candidate currently in clinical development, manufactured using Eleva (搜索)'s proprietary moss-based GMP-scale production platform. Factor H is a key complement control protein that cannot be manufactured at scale using traditional production platforms such as CHO or yeast systems.
"The successful completion of the SAD part is a significant milestone for CPV-104 and further validates our moss-based manufacturing platform," said Björn Cochlovius, Ph.D., Chief Executive Officer of Eleva (搜索). "Factor H (搜索) 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 Evidence and Regulatory Recognition
Preclinical studies demonstrated that CPV-104 is functionally equivalent to endogenous human Factor H (搜索), 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 (搜索).
CPV-104 is one of the first two clinical-stage biologics manufactured using Eleva (搜索)'s moss-based platform, alongside aGal (搜索) (RPV-001), an α-galactosidase enzyme that has successfully completed Phase 1b development for Fabry disease (搜索). The platform enables precise, scalable, and sustainable production of complex proteins with tremendous therapeutic potential that have been challenging to manufacture using other approaches.
Expanding Pipeline Applications
Beyond C3G (搜索) treatment, Eleva (搜索) is developing an intravitreal formulation of CPV-104 in late preclinical development for dry age-related macular degeneration (搜索) (AMD). The company's proprietary pipeline focuses on candidates for complement disorders and enzyme replacement therapies, leveraging the unique capabilities of its moss-based manufacturing technology.