Does Nangibotide work?
Partly: one trial of 355 patients that missed its main goal.
One randomized, double-blind, placebo-controlled phase 2b trial in 355 patients with septic shock exists. It did not meet its primary endpoint, and the encouraging signal came from an exploratory analysis in patients with higher biomarker levels. A confirmatory trial is what is missing. 1
The ASTONISH trial randomized 355 adults with septic shock to a low dose of nangibotide, a high dose or placebo, on top of standard care. The main outcome was the change in the SOFA organ failure score from baseline to day 5. It was assessed in the whole group and in a pre-specified group with soluble TREM-1 at or above a set threshold. The trial did not meet that main goal. 1
The researchers then analyzed the biomarker threshold. Patients with soluble TREM-1 above the pre-specified cutoff seemed to gain a clinically relevant SOFA improvement on the high dose compared with placebo. The low dose showed a smaller effect in the same direction. The authors say a future study must confirm this. The cutoff that showed benefit was found after the fact. 1
Evidence checklist
- Randomised controlled trial ASTONISH, double-blind phase 2b
- Human study over 100 people ASTONISH, 355 septic shock patients
- More than one research group Single trial from the sponsor
- Clinical outcomes, not surrogate markers Missed organ-failure score endpoint; no mortality data
- Human safety data beyond case reports One infusion course studied only
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Citations
- François 2023, Lancet Respir Med: nangibotide in patients with septic shock (ASTONISH), randomized phase 2b trial doi.org
Reference information only, not medical advice. Drawn from the Nangibotide article, fact-checked against the cited sources. No dosing anywhere on this site.