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Clinical trials of a "universal" snakebite antidote?

A team of independent researchers led by Dr. Matthew Lewin at Ophirex, Inc. is working to develop a universal antidote to snakebite.

Snakes bite around 5 million people each year, resulting in about 100,000 deaths worldwide. Bites are traditionally treated with antivenoms, which are snake-specific, expensive, temperature-sensitive, and often require medical expertise to administer, conditions that make snakebite difficult to treat outside a hospital. An effective antidote, in contrast, would be both heat-stable and broadly effective, interfering with venom’s destructive biochemical effects, which might include paralysis, excessive clotting or bleeding, necrosis, or a combination.

Lewin’s research team has identified varespladib and varespladib methyl, off-patent drugs originally developed as an anti-inflammatory, as potential antidotes. These drugs inhibit an enzyme called sPLA2, which is produced in the human body during inflammation and is also a component of snake venom. The drugs have been tested in humans for other uses, but never obtained FDA approval.

Early research shows that the drugs are effective in neutralizing sPLA2 in a large variety of snake venoms. In preliminary rodent studies, rats who received varespladib treatments 1-5 minutes after lethal doses of snake venom all went on to survive at least 24 hours. No human trials have yet been undertaken, though Lewin conducted a UCSF-approved trial on himself in April 2013.

Will a clinical trial be entered into the US database with a start date prior to 1/1/2018, to test the use of varespladib and/or varespladib methyl as snake venom antidotes in humans?

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