— Wellcome Award Funds Manufacture of Clinical Supply for Upcoming Ophirex Trials —
Corte Madera, Calif., Monday, March 2,2020 — Ophirex, Inc., a public-benefit biotechnology company working to improve outcomes for global victims of snakebite, announced today that it has received a $2.5 million award from the Wellcome Trust’s £80 million (approximately $100 million) commitment to improve treatment of snakebite. The award will fund manufacturing of oral and IV varespladib, Ophirex’s lead drug candidate, for use in Ophirex’s upcoming, potentially pivotal clinical trial studies.
Ophirex is developing varespladib as a first-in-class, toxin-targeting antidote for snakebite, with the ultimate goal of safe and rapid administration to snakebite victims in the out-of-hospital setting where — without immediate access to antivenom — most snakebite deaths occur. By inhibiting the progression of a key venom component called “sPLA2,” varespladib could mitigate many of the most common, immediately life-threatening effects of snakebite envenoming. In preclinical studies, the drug candidate has shown potential to act against this most lethal component of snake venoms, across a broad spectrum of geographically diverse snake species.
“Ophirex is targeting a crucial unfilled gap between when snakebite occurs and when victims can obtain medical care ¾if they have access to it at all,” said Dr. Nick Cammack, the leader of Wellcome’s snakebite priority area. “We have been impressed by the data amassed to date and excited to help support testing of the potential of Ophirex’s novel approach to transform outcomes for populations in need.”
“Wellcome has taken a leadership role in addressing the need for investment and development in snakebite treatment, and we are honored by their recognition of our potential to move the field forward,” said Nancy J. Koch, CEO of Ophirex.
Dr. Matthew Lewin, Ophirex’s founder, noted that “Wellcome is making snakebite a global public health priority and is providing a critical contribution to our effort to provide immediately accessible life- and limb-saving snakebite treatments where they are needed most.”
In conjunction with the Wellcome award, Ophirex and Wellcome have also established a group that will monitor developments in the field of snakebite treatment and identify opportunities involving Ophirex’s and other new technologies in a collaborative approach toward filling unmet needs in the field of snakebite envenoming.1,2
Wellcome’s groundbreaking £80 million program, announced in May of 2019, focuses on improving snakebite treatments and access to them and signifies important recognition of the enormous, largely unaddressed suffering of snakebite victims in often poor, rural areas of Africa, Asia and South America. The World Health Organization (WHO) reinstated snakebite envenoming to its list of neglected tropical diseases in 2017 and, more recently, has outlined strategies to reduce the death and disability toll from snakebite —currently approximately 500,000 people per year — by half by 2030. In early 2019, the WHO Snakebite Envenoming Working Group specifically identified Ophirex’s drug as a priority for accelerated study.1
1. Williams DJ, Faiz MA, Abela-Ridder B, Ainsworth S, Bulfone TC, Nickerson AD, Habib AG, Junghanss T, Fan HW, Turner M, Harrison RA, Warrell DA. Strategy for a globally coordinated response to a priority neglected tropical disease: Snakebite envenoming. Gutiérrez JM, ed. PLoS Negl Trop Dis. 2019;13(2):e0007059. doi:10.1371/journal.pntd.0007059.
2. Surugue L. Why is it so hard to stop people dying from snakebite? 2019. https://mosaicscience.com/story/snakebite-antivenom-crisis-Africa-Togo/.
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 disable sat 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. Varespladib is intended for worldwide human and veterinary use, with an oral formulation for use in the field, where most bites occur, and an intravenous formulation for use in medical settings. Ophirex was founded via the work of expedition doctor Matthew Lewin, MD, PhD, with support from musician and entrepreneur Jerry Harrison.
Ophirex, Inc., a biotechnology company dedicated to
addressing major unmet needs in tropical medicine, announced today that it has licensed data
related to sPLA2 inhibitors from Eli Lilly and Company and Shionogi & Co, Ltd. for Ophirex’s
development program for the field treatment of envenomation, especially by snakes.
Ophirex is working to develop a potential treatment that could be administered in the field to inhibit the progression of venom, thereby mitigating immediate, life-threatening effects of snakebites. Every year, approximately 5 million people worldwide are bitten by venomous snakes. Many of these bites result in envenomation, where a snake injects venom (defined as poisons that are injected by bite or sting) from its fangs into the bloodstream of its victim, disabling or disfiguring an estimated 400,000 people annually, and killing as many as 100,000 people. More than 75 percent of these deaths occur before patients receive hospital-based medical care.
The Ophirex program focuses on sPLA2 inhibitors previously studied by Lilly and Shionogi in clinical trials for unrelated indications. Ophirex identified their potential to act against a broad spectrum of snake venom sPLA2s — one of the most common and lethal components of snake venoms — and has demonstrated their potency against 28 snake venom sPLA2s from six continents. In preclinical studies, Ophirex has produced data supporting the efficacy of sPLA2 inhibitors as a therapy for snake venom (Toxins 2016, 8(9),248; doi:10.3390/toxins8090248).
“We’re very excited by the potential of these sPLA2 inhibitors to hinder the rapidly fatal effects of snake venom and transform the landscape of this ancient and still devastating affliction,” said Matthew R. Lewin, M.D., Ph.D., Ophirex’s founder. “Thanks to Lilly and Shionogi’s true commitment to accelerating this program, we can move quickly to combine our preclinical evidence and their extensive preclinical and clinical data packages to pursue development of sPLA2 inhibitors as first-in-class treatments to address this huge unmet need. Our vision is to develop the world’s first field antidote to snakebite, allowing anyone to treat any bite, any place, at any time.”
The public health emergency of snakebite, which primarily affects the world’s most impoverished populations, has recently gained international attention. Doctors Without Borders / Médicins Sans Frontières (MSF) has identified snakebite as one of the most significant medical crises facing the globe and has flagged shortages of anti-venom, especially in Sub-Saharan Africa. This summer, the World Health Organization (WHO) officially declared snakebite a Neglected Tropical Disease. The crisis has also gained the support of celebrities dedicated to global health. The first of these was Rock & Roll Hall of Famer Jerry Harrison of the Talking Heads, who, upon hearing of Dr. Lewin’s ideas helped co-found the company.
“Connecting people with better access to care drives our collaboration with Ophirex,” said Evan Lee, M.D., Vice President of Global Health, Eli Lilly and Company. “Through our new initiative, Lilly 30x30, we’re committed to helping 30 million people in resource-limited settings each year access quality care. Thinking creatively and exploring innovative partnerships is exactly how we aim to reach more people and fulfill the promise of this commitment. We applaud Dr. Lewin and Mr. Harrison for their commitment to improving lives by addressing a critical global health priority.”
The extensive research produced by Lilly and Shionogi and now licensed by Ophirex provides important insights on sPLA2 inhibitors and their potential utility against snake venom. Large datasets from clinical studies in rheumatoid arthritis, asthma, and sepsis showed that the compound of interest was safe and well-tolerated. While the compound did not show efficacy against these diseases, it clearly demonstrated a reduction of key inflammatory indicators, many which are associated with envenoming.
Dr. Matthew R. Lewin, an emergency physician and neuroscientist best known as an expedition doctor, founded Ophirex to focus on developing field treatments for snakebite. Ophirex is a public benefit corporation committed to the ideal that treatment for any snakebite can begin anywhere, anytime, by anyone. For more information, please see www.ophirex.com.
With Ophirex co-founder Mr. Jerry Harrison, a Rock & Roll Hall of Famer (Talking Heads, Modern Lovers) an experienced technology entrepreneur (MicroUnity, Garageband), Dr. Lewin has helped to raise awareness of the need to address the global snakebite epidemic. Advocacy and research by leaders in the field of snakebite, including Dr. Lewin’s, is featured in the upcoming documentary, “Minutes to Die,” premiering in fall 2017 (www.minutestodie.com).