One04 Therapeutics Will Present CPV-104 Phase 1 Data
The company will share safety and tolerability results for its Factor H therapy at ASN Kidney Week this October.
Updated on Oct. 6, 2026 in Biotech
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One04 Therapeutics is scheduled to present interim Phase 1 clinical trial data for CPV-104 on October 22, 2026. The research-stage therapy is being developed as a potential treatment for C3 glomerulopathy.
Why it matters
This clinical update provides early evidence on the safety and pharmacokinetics of a new approach to managing complement-mediated kidney diseases. It marks a critical step in assessing the feasibility of this protein-based therapy before expansion into further trials.
The study evaluates safety, tolerability, and pharmacokinetics in a single-ascending dose arm of 21 healthy volunteers and a multiple-ascending dose cohort of 18 patients. No dose-limiting toxicities have been reported in the completed single-dose study phase.
The players
One04 Therapeutics
A Freiburg-based biotech firm developing protein-based therapies for complement-mediated diseases.
Michael Wiesener
A professor and clinical researcher who will present the interim trial findings.
The details
CPV-104 is a Factor H therapy, designed to supplement the body's natural regulator of the complement system—a part of the immune system that, when overactive, can cause tissue damage. By administering this protein, the drug aims to dampen the dysregulated immune response that characterizes C3 glomerulopathy. Researchers are evaluating the drug across multiple-ascending dose cohorts to determine the optimal therapeutic concentration while monitoring for adverse immune responses.
Timeline
October 21-25, 2026: ASN Kidney Week in Denver.
October 22, 2026: Poster presentation on interim Phase 1 data.
October 26, 2026: Virtual key opinion leader event.
The Tech Race
One04 Therapeutics is positioning CPV-104 within a crowded field of emerging complement inhibitors targeting nephrological and retinal conditions. This data release at ASN Kidney Week represents the company's effort to demonstrate technical differentiation against established and pipeline-stage competitors.
This development currently exists in the research stage and does not offer a treatment option for patients. Future availability depends on the successful completion of subsequent trial phases and regulatory review.
The takeaway
The sector should watch the interim safety findings presented at ASN Kidney Week to see if the therapy maintains a clean toxicity profile as dosing progresses. Future updates will focus on the company's expansion plans into retinal indications for the Factor H candidate.
What happens next
The company will hold a virtual key opinion leader event on October 26, 2026, to discuss clinical data and future development plans for CPV-104 in kidney and retinal diseases.
Further reading
Explore the latest developments in renal treatments on our /tech/biotech/ page.
More information
To register for the company's upcoming presentation, visit the virtual KOL event registration portal.
Source note: This article includes information reported by The Manila times.
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