Germany-based One04 Therapeutics GmbH & Co. KG has launched as a clinical-stage biopharmaceutical company backed by D11Z.Ventures, following the separation of Eleva Biologics' clinical-stage Factor H program from its moss-based biologics platform. The Freiburg-based company is advancing CPV-104, a recombinant full-length human Factor H candidate, through Phase I development in C3 glomerulopathy (C3G), with plans to expand into other complement-mediated kidney diseases and dry age-related macular degeneration, including geographic atrophy.
CPV-104 is designed to restore endogenous complement regulation rather than inhibit individual components of the complement cascade, an approach the company said is intended to control pathological overactivation while preserving homeostatic immune function. The asset was discovered and developed using Eleva Biologics' moss-based Bryotechnology production platform before being transferred to One04 Therapeutics. CPV-104 holds EU Orphan Designation for C3G.
According to One04, interim data from the multiple-ascending dose (MAD) portion of the Phase I trial — covering two of three planned dose cohorts in 18 patients with C3G — showed favorable safety, tolerability, and pharmacokinetics, alongside early efficacy trends. A single-ascending dose portion completed in October 2025 across 21 healthy volunteers at four dose levels reported no safety concerns. Detailed interim results will be presented via livestream on October 26, 2026, following the American Society of Nephrology Kidney Week conference.
One04 plans to initiate an open-label Phase II study in up to 24 patients with C3G and other complement-mediated kidney diseases in early 2027, alongside a separate Phase I study in dry AMD/GA. A larger, comparator-controlled Phase II in kidney diseases is planned for late 2027, subject to additional financing.