Durham, North Carolina — September 22, 2026
Ophirex announced publication of results from the Phase 2 BRAVIO clinical trial evaluating intravenous sodium varespladib followed by oral methyl varespladib as an adjunct to standard antivenom therapy in patients with snakebite envenomation. Published in PLOS Neglected Tropical Diseases, the multicenter randomized, double-blind, placebo-controlled study enrolled 140 hospitalized patients across 18 sites in India and the United States, with 139 patients included in the analysis. The trial evaluated patients bitten by medically important elapid and viper species, including kraits, Russell’s vipers, rattlesnakes and copperheads.
BRAVIO Evaluates Varespladib After Antivenom
The BRAVIO study did not meet its prespecified primary endpoints for elapid and viper envenoming. For elapid patients, the primary endpoint assessed time to recovery of a 5-second head-lift, while the viper endpoint evaluated the area under the curve of a three-component Snakebite Severity Score through Day 14. Varespladib treatment was initiated an average of 7.3 hours after snakebite and 3.3 hours after antivenom, potentially limiting the ability to evaluate early sPLA2 inhibition. The study nevertheless identified signals of benefit in patients with envenoming associated with well-defined sPLA2-driven toxicities.
Krait and Copperhead Patients Show Benefit Signals
Among primarily krait-bite patients, varespladib-treated participants spent approximately half as much time on mechanical ventilation, at 21 hours compared with 40 hours, and experienced a 36% lower illness severity over the first week. Among copperhead patients, the treatment group experienced a 43% reduction in illness severity over the first two weeks. Varespladib was well tolerated across the study population, with no serious adverse events reported among varespladib-treated patients. Ophirex plans to publish additional subgroup analyses of krait and copperhead patients in the coming months.
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Ophirex Advances Oral Rescue Treatment Strategy
Varespladib is being developed as a potential broad-spectrum oral rescue treatment that could be administered at the time of a snakebite, before antivenom and hospital treatment. The small-molecule inhibitor targets snake venom secretory phospholipase A2 (sPLA2), a major toxin class found in the venom of more than 95% of venomous snake species. Ophirex is continuing efficacy studies under the FDA Animal Rule, which can support regulatory approval using adequate and well-controlled animal studies when human efficacy trials are unethical or infeasible. The program has received FDA Orphan Drug, Pediatric Rare Disease and Fast Track designations, while the company continues research aimed at addressing the global unmet need for rapid snakebite treatment.
Source :Ophirex press release
