Ophirex Enrolls First Patient in BRAVO Study for Snakebite Treatment
— Phase 2 Study Designed to Provide Pivotal Clinical Data on Varespladib as a Broad-Spectrum Snakebite Antidote —
— Additional Proof-of-Concept Phase 2 Study Underway to Evaluate Varespladib’s Potential to Treat Acute Respiratory Distress Syndrome (ARDS) Associated with Covid-19 —
Corte Madera, Calif., August 16, 2021 — Ophirex, Inc., a public benefit biotechnology company, announced today that the first patient has enrolled in the Phase 2 BRAVO study of its lead investigational drug candidate, oral varespladib for the treatment of snakebite. Each year, bites by venomous snakes kill or maim at least 500,000 people worldwide.
“Initiating our BRAVO study is a huge step forward in Ophirex’s effort to address the unmet medical needs associated with venomous snakebite,” said Nancy J. Koch, CEO of Ophirex. “Our team is driven by the goal of shifting the current treatment paradigm and improving treatment outcomes. We want to reach more victims of snakebite envenoming globally and help alleviate their and their families’ suffering by providing an accessible oral treatment. We’re honored to work alongside clinical and scientific leaders in this field, and we appreciate the continued support of everyone associated with our program.”
BRAVO (Broad-spectrum Rapid Antidote: Varespladib Oral for snakebite) is a multi-center, randomized, double-blind, placebo-controlled, Phase 2 study designed to evaluate the safety, tolerability and efficacy of oral varespladib concurrently with the standard of care, usually including antivenom, in subjects bitten by venomous snakes (copperhead, cottonmouth, rattlesnake, cobra, krait, Russell’s viper and saw-scaled viper). Ophirex expects the BRAVO study to enroll approximately 110 subjects ≥ 5 years of age at 17 sites in the United States and India, with most sites opening for enrollment by the end of 2021. Ophirex anticipates completing the study in 2022.
“Based on our extensive preclinical work, we believe varespladib can address several limitations, especially with respect to accessibility, of serum-based antivenoms that constitute the current standard of care for snakebite,” said Matthew R. Lewin, MD, PhD, Ophirex’s founder, Chief Scientific Officer and Chief Medical Officer. “Varespladib blocks the most lethal, nearly universal component of venom — secretory phospholipase 2 (sPLA2) enzymes — with tremendous efficiency compared to antivenoms that generally target single snake species. We have seen that, even with delayed administration, varespladib can reverse paralysis and restore normal blood clotting caused by venoms across a broad spectrum of geographically diverse snake species, giving us great hope for its life- and limb‑saving potential.”
The study will enroll patients based on a qualifying snakebite severity score (SSS). The SSS is a well-established tool used to measure the severity of envenoming based on gradings for six body categories. Both treatment arms (active and placebo) will receive standard-of-care treatment concurrently, ensuring subjects receive the best emergency care in a timely manner while being assessed for enrollment. The study’s primary outcome measure is change in combined SSS subscores from the pulmonary, cardiovascular, hematologic, and central nervous systems from baseline to post-treatment (the average of scores from 6 hours and 9 hours after the first dose).
Ophirex recently initiated an additional Phase 2 study of varespladib, as a potential treatment for acute respiratory distress syndrome (ARDS) associated with COVID-19. The STAIRS (Small Molecule Targeting Acute Inflammatory and Respiratory Symptoms in SARS-CoV-2) study is a multi-center, randomized, double-blind, placebo-controlled, proof-of-concept study to evaluate the safety, tolerability and efficacy of varespladib in patients hospitalized with ARDS and severe COVID-19. Ophirex expects STAIRS to enroll approximately 90 subjects 18–80 years of age at approximately 10 sites in the United States.
In the STAIRS study, Ophirex is gathering dose-finding data and testing varespladib’s ability to address two critical mechanisms of ARDS — stabilizing the disregulated inflammatory response and preventing lung surfactant degradation. The study’s primary outcome measure is the proportion of subjects who are free of respiratory failure after 28 days. From there, Ophirex will determine next steps for the program in consideration of the status of the pandemic.
About Ophirex, Inc.
Ophirex, Inc. is a public benefit corporation working to develop safe, effective, and accessible initial treatment for snakebite envenoming, which kills or disables at least half a million people worldwide annually, mostly in rural, impoverished areas. The company’s lead drug candidate, varespladib, blocks sPLA2, a prevalent, highly toxic component of venom present in at least 95 percent of snake venom types from around the world. Varespladib is intended for worldwide human and veterinary use, including an oral formulation suitable for use in the field, where most bites occur. The company is also working to improve outcomes for global victims of other life-threatening bites and stings as well as from diseases and conditions with related mechanisms of illness and injury. Ophirex was founded by expedition doctor Matthew R. Lewin, MD, PhD, with support from musician and entrepreneur Jerry Harrison.
Contact