Target product profiles for small molecule or engineered antibody therapeutics for treatment of snakebite envenoming

Overview

The first WHO public-benefit 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.

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 were 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.

These TPPs are intended to provide guidance to manufacturers, regulators, procurement agencies, clinicians, and researchers, to improve antivenoms and thus treatment of snakebite envenomation.