Ophirex Announces Business Update: Advances Toward Food and Drug Administration (FDA) Approval for Varespladib as Novel Oral Snakebite Treatment

Company announces agreement with FDA on human approval pathway based on Animal Rule

Varespladib has received FDA MUMS designation for treatment of snakebite in dogs

Animal health leader Aaron Schacht joins Board of Directors

New corporate brand identity, website signals progress on mission to address unmet need in snakebite envenomation treatment

CORTE MADERA, Calif., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Ophirex, Inc., a Public Benefit Corporation developing novel treatments for snakebite envenomation, today announced a series of regulatory and business developments as it continues to advance varespladib as the first oral rescue treatment for snakebite envenomation.

The company announced that the FDA agrees that development of varespladib for snakebite is appropriate under the FDA’s Animal Rule, which permits approval of drugs for human use using safety data from humans and efficacy data from well-controlled animal studies. Since 2002, more than 15 drugs have been approved under the FDA’s Animal Rule, including several that fill critical unmet needs for emergency medical care.

“Oral varespladib is a potentially groundbreaking innovation in the treatment of snakebite envenomation because it is designed to be used at the time of bite, allowing treatment to be initiated in minutes instead of hours,” said Jeremy Gowler, CEO of Ophirex. “We look forward to demonstrating varespladib’s efficacy as an early treatment for snakebite through the Animal Rule pathway.”

Studies of varespladib in animal models of envenoming that mimic human conditions are underway. Among other things, these studies will inform the determination of the fully effective dose of varespladib for snakebite and provide evidence of the breadth of benefit.

Two Phase 2 studies of varespladib in snakebite envenomation—BRAVO and BRAVIO—have been completed. Both studies were conducted with emergency department patients who had already started standard-of-care treatment, including antivenom. The primary endpoint in BRAVO was not met, but there were signals consistent with benefit in the pre-specified subgroup of patients receiving study drug in the first five hours after the bite. The results of the BRAVIO trial as well as experimental mouse studies testing varespladib against the most important venomous snakes in the U.S. will be published in the next few months.

Varespladib has received FDA Orphan Drug, Rare Pediatric Disease and Fast Track designations and is being developed with support from the Defense Health Agency’s Small Business Innovation Research (DHA SBIR) program and the Operational Medical Systems (OPMED) team under the Broad-Spectrum Snakebite Antidote (BSSA) program. The BSSA program aims to provide an FDA-approved solution for snakebite envenomation that is shelf-stable, lightweight, cost effective, easy to use in austere environments, and snake-species agnostic, while alleviating many of the logistical and administrative burdens associated with antivenom, the current standard of care for snakebite envenomation.

Animal Health Strategy
Ophirex announced that varespladib, which is also being developed as an oral rescue treatment for snakebite envenomation in dogs, has received MUMS designation for minor use in a major species from the FDA Center for Veterinary Medicine for the treatment of snakebite in dogs.

MUMS designation provides several development incentives, including eligibility for seven years of exclusive marketing rights following approval, qualification for FDA user-fee waivers and the opportunity to apply for FDA grant funding to support required studies. This designation underscores the need for a new approach to snakebite treatment, a therapeutic area that has not seen significant innovation in more than a century.

To further support Ophirex’s Animal Health market entry, Ophirex has appointed Aaron Schacht to its Board of Directors. Schacht brings deep experience in animal health research and development, regulatory affairs and business development. This includes his current role as CEO and Board Director of BiomEdit, an animal health biotechnology company, and prior leadership positions at Elanco and Eli Lilly. He has led major animal health acquisitions and has served on several biotechnology boards.

Website relaunch
Ophirex has launched a refreshed brand identity and corporate website (https://ophirex.com), reflecting the Company’s updated business strategy. The new brand underscores the company’s commitment to addressing unmet needs in human and animal health in the United States and globally by enhancing outcomes for envenomation victims.

“The team at Ophirex is committed to fundamentally changing the treatment of snakebite envenomation, offering patients an oral treatment that can be administered at the time of bite and in acute-care settings before the administration of standard-of-care antivenom,” said Gowler. “An oral treatment for snakebite has the potential to positively impact the 4-5 million people who experience venomous snakebite each year. We are committed to being a catalyst for change in how snakebite envenomation is treated in the U.S. and around the world.”

About Ophirex
Ophirex is a Public Benefit Corporation developing varespladib, a first-of-its-kind oral rescue treatment for snakebite that can be administered at the time of bite. There are approximately 4-5 million venomous snakebites globally each year, resulting in approximately 125,000 deaths and 400,000 permanent disabilities. Seventy-five percent of snakebite deaths occur prior to hospital arrival. Varespladib is a small-molecule inhibitor of snake venom secretory phospholipase A2 (sPLA2), a class of toxins present in the venom of more than 95% of venomous snake species. It rapidly inhibits sPLA2 activity and mitigates downstream toxic effects. Varespladib has received FDA Orphan Drug, Pediatric Rare Disease and Fast Track designations, recognizing its potential to address significant unmet needs in treating snakebite. Additionally, varespladib has received MUMS designation from the FDA’s Center for Veterinary Medicine for the use of varespladib for the treatment of snakebite in dogs when antivenom is not immediately available. For more information, visit www.ophirex.com.

The information contained in this press release does not necessarily reflect the position or the policy of the U.S. Government and no official endorsement should be inferred.

Media Contact:
Dan Boyle
Orangefiery
dan@orangefiery.com
(818) 209-1692