Ophirex, Inc., a Public Benefit Corporation dedicated to addressing the global unmet medical needs of snakebite victims, has announced significant findings from its BRAVO trial, published in BMJ Global Health. The study evaluated the safety, tolerability, and efficacy of oral varespladib, a novel treatment that inhibits the sPLA2 enzyme present in 95% of snake venoms. If successful in future trials, varespladib could become the first field-deployable treatment for snakebites, offering life-saving intervention at the "time-of-bite."

A Landmark in Snakebite Treatment

The BRAVO trial (Broad-spectrum Rapid Antidote: Varespladib Oral for Snakebite) is the first clinical study to evaluate a direct toxin inhibitor for snakebites across multiple continents. Conducted across sites in the U.S. and India, the Phase 2 trial enrolled 95 patients bitten by various snake species, making it a groundbreaking step in providing a broad-spectrum treatment for envenoming. The study compared the effects of oral varespladib to placebo when administered alongside standard care, including antivenom in nearly all cases.

Encouraging Results for Early Intervention

While the BRAVO trial did not meet its primary endpoint, patients who received treatment within five hours of a snakebite showed clinically significant improvements. "This early intervention subgroup saw lower illness severity, higher rates of complete recovery, and improved patient-reported outcomes," said Dr. Timothy Platts-Mills, Chief Medical Officer of Ophirex. The findings indicate that varespladib could provide essential early intervention and improve outcomes for snakebite victims before they reach a medical facility.

Addressing the Limitations of Traditional Antivenom

Unlike antivenom, which must be matched to specific snake types and carries risks of anaphylaxis and the requirement of IV administration, varespladib offers an oral, broad-spectrum solution. Charles J. Gerardo, M.D., a trial investigator from Duke University, highlighted varespladib's potential to meet an urgent need: “With 75% of venom-related deaths occurring before victims reach the hospital, early treatment is crucial. Varespladib has shown promise as a real-world treatment that could help save lives.”

In regions like India, which bear a high burden of snakebite deaths—97% of which occur in rural areas—varespladib could prove invaluable. Dr. Suneetha D.K., a BRAVO investigator, emphasized that the drug "could enable treatment at the time of the bite or en route to medical care, significantly improving access and outcomes."

A Vision for the Future of Snakebite Treatment

Ophirex’s Chief Scientific Officer, Dr. Matthew R. Lewin, sees this trial as a stepping stone toward bringing life-saving snakebite treatment directly to the field. “These findings reinforce our commitment to developing varespladib as an oral field treatment,” he said. Ophirex is now focusing on applying insights from the BRAVO trial to future studies, advancing their goal of providing effective, accessible snakebite treatments.

The BRAVO trial’s published manuscript, “Oral Varespladib for the Treatment of Snakebite Envenoming in India and the United States (BRAVO): A Phase 2 Randomised Clinical Trial,” is available in BMJ Global Health.