BIA 10-2474 was a phase 1 pipeline drug that in its initial human safety trials left a volunteer brain dead in January 2016 and four of the six given the highest dose with neurological injury. It was being developed as a fatty acid amide hydrolase inhibitor by Bial. A report was released by the French medicines regulatory agency in April 2016 that revealed that toxicity unreported at the time to the relevant regulators could have occurred in monkey studies and that dosing and pharmacodynamics in man were based on animal models and pharmacomolecular modelling that was incomplete. It is clear from the fact that one out of the volunteers given an equivalent dose had no severe adverse reaction that human pharmacodynamics and drug actions showed marked variation. Recommendations have followed on the conduct of phase 1 human clinical trials.
- ↑ Moore N. Lessons from the fatal French study BIA-10-2474. BMJ (Clinical research ed.). 2016; 353:i2727.(Epub)
- ↑ Lessons from the fatal French study BIA-10-2474. BMJ (Clinical research ed.). 2016; 353:i2956.(Epub)
- ↑ Report by the Temporary Specialist Scientific Committee (TSSC),"FAAH(Fatty Acid Amide Hydrolase)", on the causes of the accident during a Phase 1 clinical trial in Rennes in January 2016 Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) 25 April 2016, accessed 234 August 2016