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Peer-reviewedCC BYTranslational stroke research

First-in-Human Phase 1b/2a Trial Shows Safety with MEK 1/2 Inhibitor EDV2209 as A Novel Treatment for Spontaneous Subarachnoid Hemorrhage.

  • Emelie P Fungbrant1,2
  • Jesper Peter Bömers2
  • Helene Ravnholt Jensen3
  • Kirsten Møller1,3
  • Troels Halfeld Nielsen4
  • Erik Kinnman5
  • Diana N Krause6
  • Tiit Mathiesen7,8,9
  • Lars Edvinsson5
9 affiliations
  1. 1Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
  2. 2Department of Neurosurgery, Copenhagen University Hospital- Rigshospitalet, Copenhagen, Denmark.
  3. 3Department of Neuroanaesthesiology, Copenhagen University Hospital- Rigshospitalet, Copenhagen, Denmark.
  4. 4Department of Neurosurgery, Odense University Hospital, Odense, Denmark.
  5. 5Department of Clinical Sciences, Division of Experimental Vascular Research, Lund University, Lund, Sweden.
  6. 6Department of Pharmaceutical Sciences, School of Pharmacy & Pharmaceutical Sciences, University of California, Irvine, CA, United States of America.
  7. 7Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark. [email protected].
  8. 8Department of Neurosurgery, Copenhagen University Hospital- Rigshospitalet, Copenhagen, Denmark. [email protected].
  9. 9Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. [email protected].
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Abstract

We report findings from a Phase 1/2a clinical trial (EUCT No. 2024-514590-22-00, STOP-DCI), an interventional, randomized, double-blind, placebo-controlled, multiple ascending-dose, first-in-human trial to determine safety and evaluate clinical outcome for the MEK 1/2 inhibitor EDV2209 in patients with severe spontaneous subarachnoid hemorrhage (SAH). In Phase 1b (N = 11), three cohorts received a single intracerebral ventricular (ICV) bolus (8.55 µg, 17-28.5 µg). In Phase 2a (N = 16), two cohorts were given three ICV injections of 28.5 µg EDV2209 or placebo over 18 h, beginning within 8 h of SAH onset.The study found an equal distribution of adverse events between treatment and placebo with no treatment-associated safety concerns. Outcomes and mortality were as expected or better for patients with severe SAH in the patients treated with EDV2209. Pharmacokinetics were reproducibly stable in the CSF with no detectable levels of EDV2209 in plasma.Treatment with EDV2209 was considered safe and was interpreted to provide potential benefit for improving patient outcome following severe SAH. These results provide a rationale to continue with a Phase 2b / 3 study powered to determine efficacy as well as safety.

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Cite

BibTeXRIS
BibTeX
@article{fungbrant2026firstinhuman,
  title = {{First-in-Human Phase 1b/2a Trial Shows Safety with MEK 1/2 Inhibitor EDV2209 as A Novel Treatment for Spontaneous Subarachnoid Hemorrhage.}},
  author = {Emelie P Fungbrant and Jesper Peter Bömers and Helene Ravnholt Jensen and Kirsten Møller and Troels Halfeld Nielsen and Erik Kinnman and Diana N Krause and Tiit Mathiesen and Lars Edvinsson},
  journal = {Translational stroke research},
  year = {2026},
  month = oct,
  doi = {10.1007/s12975-026-01504-y},
  url = {https://europepmc.org/article/MED/42957924},
  note = {CC BY},
}
RIS
TY  - JOUR
TI  - First-in-Human Phase 1b/2a Trial Shows Safety with MEK 1/2 Inhibitor EDV2209 as A Novel Treatment for Spontaneous Subarachnoid Hemorrhage.
AU  - Emelie P Fungbrant
AU  - Jesper Peter Bömers
AU  - Helene Ravnholt Jensen
AU  - Kirsten Møller
AU  - Troels Halfeld Nielsen
AU  - Erik Kinnman
AU  - Diana N Krause
AU  - Tiit Mathiesen
AU  - Lars Edvinsson
PY  - 2026
DA  - 2026/10/30
JO  - Translational stroke research
DO  - 10.1007/s12975-026-01504-y
UR  - https://europepmc.org/article/MED/42957924
AB  - We report findings from a Phase 1/2a clinical trial (EUCT No. 2024-514590-22-00, STOP-DCI), an interventional, randomized, double-blind, placebo-controlled, multiple ascending-dose, first-in-human trial to determine safety and evaluate clinical outcome for the MEK 1/2 inhibitor EDV2209 in patients with severe spontaneous subarachnoid hemorrhage (SAH). In Phase 1b (N = 11), three cohorts received a single intracerebral ventricular (ICV) bolus (8.55 µg, 17-28.5 µg). In Phase 2a (N = 16), two cohorts were given three ICV injections of 28.5 µg EDV2209 or placebo over 18 h, beginning within 8 h of SAH onset.The study found an equal distribution of adverse events between treatment and placebo with no treatment-associated safety concerns. Outcomes and mortality were as expected or better for patients with severe SAH in the patients treated with EDV2209. Pharmacokinetics were reproducibly stable in the CSF with no detectable levels of EDV2209 in plasma.Treatment with EDV2209 was considered safe and was interpreted to provide potential benefit for improving patient outcome following severe SAH. These results provide a rationale to continue with a Phase 2b / 3 study powered to determine efficacy as well as safety.
SN  - 1868-4483
SN  - 1868-601X
ER  -