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 Fungbrant, Jesper Peter Bömers, Helene Ravnholt Jensen et al.
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In 30 seconds
The STOP-DCI first-in-human Phase 1b/2a interventional, randomized, double-blind, placebo-controlled trial evaluated intracerebroventricular EDV2209, a MEK 1/2 inhibitor, in patients with severe spontaneous subarachnoid hemorrhage. Phase 1b included 11 patients receiving a single dose; Phase 2a included 16 patients receiving three injections of EDV2209 or placebo over 18 hours. Adverse events were equally distributed between treatment and placebo, with no treatment-associated safety concerns. Outcomes and mortality among EDV2209-treated patients were described as expected or better, but the study was not powered to establish efficacy.
Key findings
- Adverse events were equally distributed between EDV2209 and placebo, with no treatment-associated safety concerns reported.
- In Phase 2a, 16 patients received three intracerebroventricular injections of 28.5 µg EDV2209 or placebo over 18 hours.
- EDV2209 levels were reproducibly stable in cerebrospinal fluid, with no detectable drug in plasma.
- Outcomes and mortality in treated patients were described as expected or better for severe subarachnoid hemorrhage.
Why it matters
Severe spontaneous subarachnoid hemorrhage has substantial clinical consequences, and this early trial provides initial human safety and pharmacokinetic data for intracerebroventricular EDV2209. The findings support further evaluation, while the small early-phase study and lack of efficacy-powered results mean that any potential outcome benefit remains uncertain.
What to keep in mind
The early-phase study included small cohorts and was not powered to determine efficacy.