Fabentech announces the launch and first results of first-in-human clinical trial evaluating the safety of its antidote against a deadly plant-based toxin of bioterrorism interest.

Lyon, 20 June 2024 – Fabentech, a pharmaceutical-stage biotechnology company specialized in the development, production, and marketing of polyclonal antibodies to answer emergency situations and to treat emerging infectious diseases, received approval from ANSM to conduct a phase 1 clinical trial for FBT-002. Today, the company announces that the target therapeutic dose of the clinical trial has been administrated to healthy volunteers after dose escalation and is well tolerated.

FBT-002 is an innovative post-exposure antidote designed to combat lethal plant-based toxin intoxication and to counter fatal consequences on human body.

This highly lethal toxin causes death within a few hours to a few days regardless of the intoxication route. It can be weaponized and disseminated by bioterrorists. To date, no treatment is available in the market and FBT-002 addresses this unmet medical need. The antidote, a polyclonal antibodies treatment based on Fabentech broad-spectrum technology, is capable of countering different varieties of this deadly plant-based toxin.

Conducted as a single-center, randomized, double-blind, placebo-controlled trial, this phase 1 clinical study endeavours to primarily assess treatment safety in healthy volunteers through dose-ranging studies. The secondary objective is to determine the pharmacokinetic profile of a single intravenous dose of FBT-002.