The World Health Organization (WHO) has published a first set of Target Product Profiles (TPPs) for the treatment of snakebites using novel therapeutics. The objective of these TPPs is to provide researchers, regulators and manufacturers with essential information about the minimum and optimum characteristics of potential treatments for snakebites, whether small molecule drugs or engineered antibody biologics. Our aim in doing this is to generate a set of guidelines for products in development, to ensure that they are designed and manufactured to match the clinical needs of populations at risk, and are both safe and effective.
New treatments for approximately 5.4 million people who are bitten by snakes each year are urgently needed. Safe, effective antivenoms could prevent many of the 83 000-138 000 deaths caused by snakebites and reduce the severity of serious disabilities that impact many thousands more victims.
These new TPPs complement equivalent documents published in 2023 and 2024 for conventional antivenoms intended for the sub-Saharan Africa and South Asian markets. By making the three documents as similar as possible, we hope to engender greater global equity in the antivenom market. Where they differ markedly is that the previous TPPs are primarily aimed at improving conventional antivenom products already on the market whereas this new document is aimed for products in early-stage drug development and/or in clinical trials.
Two TPPs for different clinical settings
The first TPP is for therapeutics to be used in a hospital setting. Conventional antivenoms are all used in hospitals and nay new treatment may be an adjunct to treatment with a conventional antivenom, or replace it. It is for treatment of bites from any species of venomous snake.
The second TPP is for products to be used against any species of snake in a post-snakebite pre-hospital setting, either ‘buying time’ to move a victim to a hospital for more conventional treatment or abrogating the need to go to hospital at all.
These TPPs, are intended to provide guidance to researchers, regulators and manufacturers, and will contribute to improvements in the quality, safety and effectiveness of treatments for snakebites.