Eleva has initiated dosing in its Phase I trial of its recombinant human complement Factor H (CPV-104) programme, aimed at treating C3-glomerulopathy (C3G), a rare renal disease.
The trial is currently evaluating CPV-104’s single-ascending doses in healthy volunteers.
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C3G occurs due to the abnormal regulation of the complement system.
Factor H is being explored as a therapeutic approach to aid in restoring balance within the complement system.
Preclinical data, published in Frontiers in Immunology, have demonstrated CPV-104’s potential as a functional analogue of human Factor H, supporting serum C3 level normalisation and promoting the quick degradation of C3 deposits present in the kidneys.
Eleva CEO Björn Cochlovius said: “Today’s news marks our second proprietary programme advancing into clinical trials, which is a great achievement from an organisational standpoint.
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By GlobalData“Our Factor H biological therapy platform continues to evolve, gaining visibility among clinicians and potential partners alike.”
The Factor H programme has been granted orphan drug designation within the European Union (EU) for C3G treatment and is additionally being explored for dry age-related macular degeneration (AMD) as a second indication.
Eleva chief medical officer Dr Martin Bauer said: “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. I like to thank all team members at Eleva and our clinical partners for their continued efforts and commitment to meet this milestone.”
The company leverages its moss-based technology platform for good manufacturing practice (GMP)-scale manufacturing of human proteins.
Eleva’s pipeline comprises candidates for complement disorders and enzyme replacement therapies.
Notably, the company’s aGal (RPV-001) programme has completed a Phase Ib single-dose trial for the treatment of Fabry disease.
