The following is a summary of “Safety, tolerability, pharmacokinetics, and efficacy of kukoamine B in patients with sepsis: A randomized phase IIa trial,” published in the April 2023 issue of the Critical Care by Hu et al.

Kkoamine B (KB) is an alkaloid molecule with a strong affinity for both lipopolysaccharide (LPS) and oligodeoxynucleotides containing CpG patterns (CpG DNA). Its effects on patients with sepsis-induced organ failure will be studied. The study was a phase IIa randomized, double-blind, placebo-controlled experiment across multiple sites. Every 8 hours for 7 days, patients with organ failure due to sepsis were randomly assigned to receive either KB (0.06, 0.12, or 0.24 mg/kg) or a placebo. Secondary objectives were pharmacokinetic (PK) measures, changes in the level of inflammatory mediators, and prognostic markers.

Of the 44 patients enrolled, 28 experienced adverse events (n = 20, 66.7% (KB pooled); n = 8, 57.1% (placebo)), and 14 experienced treatment-emergent adverse events (n = 10, 33.3% (KB pooled); n = 4, 28.6% (placebo)). Among the patients observed for a 28-day period, seven deaths occurred (four in the KB pooled group, 13.3%, and three in the placebo group, 21.4%), none of which were attributed to the study medication. PK data indicated that drug exposure was dose-dependent and no drug buildup occurred. The SOFA score, the number of days without vasopressors, and the number of days without ventilation were not affected by KB. KB was well tolerated and safe for patients with organ failure due to sepsis. Researchers need to go deeper into this.

Source: sciencedirect.com/science/article/abs/pii/S0883944123000436