Case study of
#00134 Deploy repurposed small-molecule toxin inhibitors as broad-spectrum early therapy
Puducherry, India (multi-site trial, with sites also in the USA)
#00133
Implementer
Ophirex, Inc. (sponsor), with emergency-department sites in India and the USA
Timeline
Aug 1, 2021 – Nov 30, 2022
Location
Description
BRAVO was a double-blind, randomised, placebo-controlled phase II trial of oral varespladib-methyl plus standard care (including antivenom) versus standard care plus placebo, run in emergency departments in India (Puducherry) and the USA. 95 patients were randomised across Russell's viper, copperhead, and rattlesnake bites. The overall primary endpoint (improvement in Snakebite Severity Score) was not statistically significant, but a prespecified subgroup treated within 5 hours of the bite showed clinically important benefit in illness severity, patient-reported function, and complete recovery. Published in BMJ Global Health (Oct 2024).
Metrics
3Lessons learned
- The overall primary efficacy endpoint was not met (p=0.13); varespladib is promising but unproven as standard therapy on this evidence alone.
- Benefit concentrated in patients treated within 5 hours identifies time-to-treatment as the critical variable, arguing for pre-hospital or field administration in future trials.
- Oral tolerability and safety were established (zero deaths or treatment-emergent serious adverse events), clearing a path for larger trials powered on early-treatment windows and viper-dominant settings.
Documented Jul 8, 2026
History
· 1Arnaud Gissinger · 1h ago · approved by Arnaud Gissinger 1h ago