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December 8, 2025BloodOpen Access

KP104, a bifunctional C5 mAb–Factor h fusion protein, demonstrates sustained long-term efficacy and safety in complement inhibitor–naïve PNH patients: 2-year results from A phase 2 study with 8-week post-treatment safety follow-up.

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Authors

LZLi ZhangCYChen YangFZFengkui Zhang

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Overview

Phase 2 trial shows KP104 improves hemoglobin levels and maintains safety in PNH patients, suggesting robust treatment potential.

Key Points

  • To evaluate the long-term efficacy and safety of KP104 in complement inhibitor-naïve PNH patients over a two-year period.
  • Phase 2 trial with 18 patients enrolled in dose-escalation cohorts
  • Patients received KP104 for over two years followed by an 8-week safety follow-up
  • Efficacy outcomes assessed included hemoglobin levels and LDH levels.
  • Substantial clinical improvements in hemoglobin observed at one year sustained through two years
  • 100% of patients maintained hemoglobin increase of ≥2 g/dL from baseline
  • No serious adverse events recorded during the two-year treatment period.

Cite This Study

Zhang et al. (2025) studied this question.

synapsesocial.com/papers/69362f364fa91c937236d316https://doi.org/10.1182/blood-2025-1118
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