RAISE: Recombinant Antivenoms for Intervention of Snakebite

Objective

Snakebite envenoming is a neglected tropical disease that causes over 100,000 deaths and claims 6 million disability-adjusted life years annually. Plasma-derived antivenoms are life-saving but face major limitations, including high cost, batch variability, narrow species coverage, risk of severe adverse reactions, and poor efficacy against local tissue damage. Safer, more effective, and broadly neutralizing therapies are urgently needed. RAISE will advance the world’s first recombinant snakebite antivenom. My team and I have developed an oligoclonal mixture of eight broadly neutralizing nanobodies that reduces local tissue damage and protects against lethality from 17 of the most medically relevant African elapids in mice (Ahmadi et al. Nature 2025). However, rodent models poorly predict human pharmacokinetics, making large-animal models essential for generating translational data on circulation, distribution, and toxin-neutralizing properties. In RAISE we will: (i) conduct pharmacokinetic studies in a large animal model, comparing monomeric and half-life-extended nanobody constructs to generate data that will guide product design, dosing, and regulatory dialogue for first-in-human trials; (ii) map regulatory and clinical trial pathways in relevant geographies, benchmarking against EMA, FDA, and WHO prequalification requirements while aligning with Target Product Profiles (TPPs); and (iii) develop a business plan covering market and pricing analysis, go-to-market strategy, growth opportunities with partners and investors, exit strategies, and intellectual property strategies. By addressing critical scientific, regulatory, and business uncertainties, RAISE will de-risk the path to clinical translation and lay the foundation for a spin-out company. In doing so, we will RAISE the standard of care and improve access to safe, effective, and affordable recombinant antivenoms for snakebite victims.