OPHIREX, INC — Department of Defense SBIR Phase II: DHA18-002

Description

The treatment of snakebite envenoming is an urgent, global unmet medical need and clear occupational hazard with a pervasive psychological burden to U.S. and allied military personnel. Our soldiers, non-combat service members and their canine companions face the occupational hazard of snakebite while working in remote areas, potentially unable to evacuate because of combat or inclement conditions. It is estimated that worldwide more than 5 million snakebite envenomings occur annually with approximately 400,000 permanent deformities or amputations and over 135,000 deaths every year1,2. While not all snakebites result in envenoming and morbidity and mortality, often by the time patients receive the appropriate medical care in a hospital setting it is far too late and the toxicities of snakebite envenoming have substantially progressed and no longer amenable to effective treatment by antivenom therapy3,4. To underscore the urgency of the global public health crisis posed by snakebite envenoming, the World Health Organization (WHO) recently classified snakebite envenoming as a neglected tropical disease2. Furthermore, the WHO’s Snakebite Envenoming Working Group stated that the accelerated development of promising prehospital treatments, such as Varespladib, the phospholipase A2 (PLA2) inhibitor being developed by Ophirex, may lead to improvements in prehospital survival. Snake venom PLA2 is involved in virtually every critical venom effect and exists as a major weapon in virtually all venomous snakes around the world7-12. Phase II enhancement funds will be used to develop a low dose oral formulation of Varespladib to broaden applicability to a greater variability of patient weights and allow oral dosage in a patients with difficulty swallowing. Eventually, the Varespladib low dose capsule will be used as a first step towards development of a combination prinomastat and Varespladib drug to provide full efficacy against snakebite envenoming. Ultimately, treatments with Varespladib, in its IV and oral formulations, will support significantly better patient outcomes over current antivenom capabilities. The eventual addition of a metalloprotease inhibitor, such as prinomastat will provide complete coverage for snakebite and minimize the burden of snakebite envenoming globally where the burden is greatest and the need desperate for attention to this long-neglected scourge.