A PHASE II TRIAL has revealed that antisecretory factor therapy reduced 30-day mortality in patients with severe traumatic brain injury (TBI), offering a promising, low-cost intervention for low- and middle-income countries where treatment options remain scarce.
Isolated severe TBI has remained a leading cause of death and disability worldwide, particularly in low- and middle-income countries (LMICs) with limited neurocritical care access. While pharmacological and non-pharmacological therapies have shown promise experimentally, no trial has demonstrated robust clinical efficacy in humans. Antisecretory factor (AF), a 41 kDa endogenous protein with antisecretory and anti-inflammatory properties, has emerged as a candidate therapy delivered via Salovum®, an AF-rich egg yolk powder classified as a food supplement for specific medical purposes in the EU and US.
This prospective, double-blind, placebo-controlled phase II trial ran from September 2017 to February 2022 at a tertiary trauma centre in Cape Town, South Africa (NCT03339505). Investigators enrolled adults aged 18 to 61 years with isolated severe TBI (Glasgow Coma Score 6 to 8) requiring intracranial pressure (ICP) monitoring. Participants received Salovum® or placebo via nasogastric tube, dosed by bodyweight (10 to 17 g every 4 hours) from a mean of 32.9 hours post-injury, for up to 5 days.
The primary outcome was 30-day mortality; secondary outcomes were therapy intensity level (TIL) and ICP. In total, 100 participants were randomised (49 treatment, 51 control); 96% were male, with a mean age of 33 years.
The 30-day mortality rate was 20% in the Salovum® group versus 39% in the placebo group, a relative risk of 0.52 (95% CI: 0.271 to 0.997, P=0.040, chi-square test). TIL and ICP scores were similar between groups, and no significant adverse events occurred in either arm.
Antisecretory factor therapy has demonstrated a significant reduction in 30-day mortality among adults with severe TBI in a resource-limited LMIC setting, researchers report. Although its precise mechanism of action remains unclear, AF’s favourable safety profile and ease of administration support further evaluation in larger, multicentre randomised controlled trials. Given the single-centre design and modest sample size, antisecretory factor warrants validation in wider populations before informing routine TBI management.
Reference
Cederberg D et al. Salovum® reduces mortality in isolated severe traumatic brain injury: a randomized phase II trial. Brain. 2026;awag241.
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