Ophirex Receives FDA Fast Track Designation for Varespladib
Treatment for Snakebite
— Targeting Pivotal Clinical Data in Early 2023 from Study Underway
in the United States and India —
Corte Madera, Calif., March 14, 2022 — Ophirex, Inc., a public benefit biotechnology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to varespladib-methyl (“oral varespladib”) for the treatment of snakebite. Ophirex is currently conducting a clinical trial of oral varespladib, its lead investigational drug candidate, as a broad-spectrum snakebite antidote in the United States and India.
“Each year, bites by venomous snakes kill or maim more than 500,000 people worldwide, many of whom are children. They also pose risks to U.S. military personnel at home and abroad. Our urgent mission is to develop more effective and more accessible treatments for snakebite victims. We are grateful the FDA recognizes this need,” said Nancy J. Koch, CEO of Ophirex. “The Fast Track designation will allow Ophirex to pursue an accelerated review of its snakebite antidote and benefit from additional input from the FDA.”
The Fast Track program is one of several approaches the FDA uses to fill unmet patient needs by making important new drugs available as quickly as possible. The FDA’s Fast Track specifically focuses on expedited review of treatments being developed for serious and life-threatening medical conditions such as snakebite. The FDA considers a medical need to be unmet if there are no approved treatments or if a new treatment has the potential to result in better outcomes than existing treatments.
“We look forward to working with the FDA as we evaluate varespladib’s potential to address accessibility, cost, and other limitations of the current standard of care for snakebite,” said Matthew Lewin, M.D., Ph.D., Ophirex’s Founder and Chief Scientific Officer. “Based on our own work as well as extensive preclinical validation from independent laboratories, we think varespladib’s uniquely potent ability to block venom secretory phospholipase A2 (sPLA2) will result in much better patient outcomes following the bite of a venomous snake. sPLA2 is one of the most lethal and commonly occurring components of snake venom. A broad-spectrum, oral treatment for snakebite would bring unprecedented accessibility of treatment to those most in need, providing greatly needed modernization to the treatment of snakebite.”
Ophirex is currently conducting its BRAVO (Broad-spectrum Rapid Antidote: Varespladib Oral for snakebite) study in the United States and India. BRAVO is a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and efficacy of oral varespladib in addition to standard of care in subjects with moderate or severe venomous snakebites. The trial is not limited to a specific type of snake but likely will include bites from rattlesnakes, cottonmouths, copperheads, coral snakes, cobras, kraits, Russell’s vipers, and saw-scaled vipers. Ophirex anticipates completing the study by the end of 2022.
About Ophirex, Inc.
Ophirex, Inc., is a Public Benefit Corporation working to develop safe, effective, and accessible treatment for snakebite envenoming as well as to overcome many types of antivenom-resistant snakebite syndromes. The WHO has declared snakebite a neglected tropical disease and estimates that snakebites annually kill or disable half a million people worldwide. Most victims of snakebite live in rural, impoverished areas and more than 75% of deaths from snakebite occur prior to arrival at the hospital. The company’s lead drug candidate, varespladib, blocks sPLA2, a nearly ubiquitous and highly toxic component of venom present in at least 95 percent of snake venoms. Varespladib is intended for worldwide human and veterinary use, including a safe, easy-to-use oral formulation suitable for administration immediately following snakebite. Ophirex was founded via the work of expedition doctor Matthew R. Lewin, M.D., Ph.D., with support from musician and entrepreneur Jerry Harrison.
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