Efficacy signal observed in subgroup of victims treated within five hours of bite reinforces critical importance of timely treatment and need for a field therapy that could improve patient outcomes
Globally, 75% of deaths from venomous snakebites occur before the victim can reach appropriately-equipped medical care
CORTE MADERA, Calif.--(BUSINESS WIRE)--Ophirex, Inc., a Public Benefit Corporation developing an oral treatment to address the unmet medical needs of snakebite victims globally, today announced that BMJ Global Health has published data from the company’s BRAVO trial evaluating oral varespladib. Varespladib is a small synthetic molecule that directly inhibits secretory phospholipase A2 (sPLA2), an enzyme that is present in more than 95% of all snake venoms. The oral form is being developed as an early intervention treatment for patients and has potential to be the first-ever field therapy for snakebite envenoming, providing treatment at “time-of-bite.”
The article in BMJ Global Health details results from BRAVO (Broad-spectrum Rapid Antidote: Varespladib Oral for snakebite), a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study designed to evaluate the safety, tolerability and efficacy of oral varespladib. It enrolled 95 patients in the U.S. and India who were administered either varespladib or placebo in conjunction with the standard of care, which included antivenom in 93 of the 95 patients.
“The BRAVO trial set out to do something no one has done before. In addition to being the first study to evaluate a direct toxin inhibitor for the treatment of snakebites, BRAVO was the first clinical trial to enroll patients bitten by any species of snake across two continents, including some of the world’s deadliest species,” said Timothy Platts-Mills, M.D., MSc, Chief Medical Officer of Ophirex. “While this Phase 2 study did not meet its primary endpoint, a promising signal of benefit was seen in the group of patients receiving treatment within five hours of a bite, reinforcing varespladib’s potential as an early treatment option and suggesting initial utility as a field treatment.”
For the early treatment subgroup, clinically important differences were observed across important outcomes, such as lower illness severity over the first week, higher rates of complete recovery, and improved patient-reported function in patients receiving varespladib. Results from the BRAVO trial also suggest that varespladib is safe and well tolerated for the treatment of snakebite, adding to a robust body of safety data for this therapeutic candidate.
“Antivenom, the current standard of care for snakebites, has several limitations, including the need to match antivenom to specific snake types, the risk of anaphylaxis, and the need to be administered intravenously in a medical setting. Yet we know that 75% of deaths due to venomous snakebites occur before the victim ever reaches the hospital. Even in those patients who survive, early treatment leads to better outcomes,” said Charles J. Gerardo, M.D., Professor and Chair for the Department of Emergency Medicine at Duke University and BRAVO trial investigator. “These data represent an encouraging advancement for patients bitten by snakes with the potential to fill a significant unmet need as a real world, early treatment before a patient reaches a healthcare facility.”
“India has the greatest snakebite burden in the world, and 97% of snakebite deaths in the country occur in rural areas far from medical care and current treatments. A novel therapeutic molecule such as oral varespladib in addition to standard of care has the potential to enable treatment at the time of bite or en route to a more advanced facility and could be an important improvement in care for patients and medical systems alike,” said Dr. Suneetha D.K., Professor and Head of Internal Medicine, Mysore Medical College and Research Institute, Mysuru and a BRAVO trial investigator.
“These findings support Ophirex’s vision to advance varespladib initially as an oral field treatment available at the time of the bite. We look forward to applying key learnings from this clinical trial to ongoing studies that address the long unmet need for a field treatment,” said Matthew R. Lewin, MD, PhD, Chief Scientific Officer and Founder of Ophirex, who first published the concept of this molecule as a field treatment in snakebite in 2016.
The manuscript, titled “Oral Varespladib for the Treatment of Snakebite Envenoming in India and the United States (BRAVO): A Phase 2 Randomised Clinical Trial,” is available online here.
About Ophirex
Ophirex is a Delaware Public Benefit Corporation developing a first-of-its-kind oral treatment to address the global unmet need of venomous snakebites. Worldwide, there are approximately 500,000 cases of snakebite envenoming resulting in death or permanent disability each year. While antivenom has been the standard of care to treat these bites for more than 100 years, it can only be administered in a hospital setting. This poses a significant challenge as 75% of deaths from venomous snakebites occur before the victim can reach appropriately equipped medical care. Ophirex is advancing its investigational treatment, varespladib, as a broad-spectrum treatment for snakebite in both oral and intravenous formulations with human and veterinary applications. Ideally taken immediately following a bite, it is intended to provide a bridge to survival between bite and arrival to the hospital. If successful, this early intervention is anticipated to result in improved overall outcomes for patients at risk of death and long-term disability from snakebite. The company has presented some of the BRAVO data at scientific conferences. Ophirex is concluding a separate Phase 2 study to evaluate IV-to-oral dosing of varespladib for snakebite envenoming based on learnings from BRAVO.
For more information, visit www.ophirex.com.
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