First clinical data for CPV-104 in patients, including interim safety, tolerability and pharmacokinetics, accepted as a late-breaking poster
Expert panel to join One04 management in a virtual key opinion leader (KOL) event to discuss the data on October 26, 2026, at 5pm CET (4pm GMT, 12pm ET)
Registration now open for the virtual KOL event
Freiburg, Germany, October 6, 2026 – One04 Therapeutics GmbH & Co. KG, a clinical-stage biopharmaceutical company developing CPV-104, a first-in-class, recombinant, full-length human Factor H therapy, today announced the acceptance of a late-breaking poster presenting positive interim data from the ongoing Phase 1 study of CPV-104 at the American Society of Nephrology (ASN) Kidney Week, taking place October 21-25, 2026, in Denver, Colorado.
In the poster session, Prof. Dr. Michael Wiesener, Department of Nephrology and Hypertension, University Hospital Erlangen, will present an interim analysis of safety, tolerability and pharmacokinetics (PK) from the first two cohorts of patients with C3 glomerulopathy (C3G) in the multiple-ascending dose (MAD) portion of the study.
Following ASN Kidney Week, Dr. Wiesener will join One04 management and an expert panel in a virtual key opinion leader (KOL) event on October 26, 2026, to discuss the safety, tolerability and PK data and encouraging early signals of clinical activity in the ongoing Phase 1 trial in more detail. Management will also present future development plans for CPV-104 in complement-mediated kidney and retinal diseases.
ASN Kidney Week presentation details Title: First-in-human clinical trial of CPV-104, a recombinant version of human complement Factor H: safety, tolerability, and pharmacokinetics for C3 glomerulopathy Presenting author: Prof. Dr. Michael Wiesener, Department of Nephrology and Hypertension, University Hospital Erlangen, Germany Poste number: TH-PO1261
Date and time: October 22, 2026 from 10:00 AM to 12:00 PM MDT
Virtual KOL event details Title: Discussion of positive interim Phase 1 data for CPV-104 in patients with C3G Company presenters: Dr. Björn Cochlovius, Chief Executive Officer Dr. Erich Rajkovic, MBA, Chief Business Officer KOL presenters: Dr. Marc Hilhorst, Department of Nephrology and Renal Transplantation, Amsterdam University Medical Center Prof. Dr. Bernd Jilma, Department of Clinical Pharmacology, Medical University of Vienna Dr. Dinesh Khullar, Chairman, Department of Nephrology and Renal Transplant Medicine, Max Super Speciality Hospital, Saket Prof. Dr. Michael Wiesener, Department of Nephrology and Hypertension, University Hospital Erlangen Prof. Dr. Peter Zipfel, Koania Complement Analytics GmbH
Moderator: Dr. Sarah Jarvis, GP and Visiting Professor of General Practice, University of Huddersfield, UK Date and time: October 26, 2026, at 5pm CET (4pm GMT, 12pm ET) Registration: https://www.q2q.co.uk/CPV-104-KeyData-Release/access
The placebo-controlled single-ascending dose (SAD) study arm evaluated CPV-104 across four dose cohorts in 21 healthy volunteers, with no dose-limiting toxicities or treatment-related serious adverse events observed. The subsequent MAD portion of the Phase 1 trial includes three dose cohorts totaling 18 patients. Dosing of the highest dose cohort is currently ongoing.
ABOUT ONE04 THERAPEUTICS One04 Therapeutics is a clinical-stage biopharmaceutical company developing CPV-104, a first-in-class, recombinant, full-length human Factor H therapy. Factor H has been widely researched and has broad potential to treat complement-mediated diseases of the kidney and eye. Early CPV-104 Phase 1 clinical data showed good initial safety, tolerability and early signals of biological activity in patients with a complement-mediated kidney disease. Factor H is known to restore endogenous complement regulation from pro-inflammatory toward immune homeostasis, suggesting CPV-104 has disease-modifying potential and should work well in combination with marketed therapies.
For regular updates about One04 Therapeutics, visit www.one04.com or follow us on LinkedIn.
MEDIA CONTACTS Fabienne Zeitter Director Corporate Communications [email protected] Phone: +49 172 6565 227 Valency Communications Mario Brkulj [email protected] Phone: +49 160 9352 9951
INVESTOR CONTACT
Cohesion Bureau Giovanni Ca’ Zorzi [email protected] Phone: +33 7 84 67 07 27
