FDA moves to understand fateful France-based Biotrial Phase I study

The US Food and Drug Administration is conferring with European regulators after a Phase I clinical study, conducted by French clinical research organization Biotrial, recently resulted in the death of one enrolled subject and neurological injury to four others.

The study had focused on BIA 10-2474, an Investigational New Drug (IND) manufactured by Portugal’s largest drugmaker Bial (The Pharma Letter January 16). Although no clinical studies with BIA 10-2474 have occurred in the USA, the FDA is conferring with the European Medicines Agency and the French national medicines agency (ASNM). French authorities continue to investigate the events reported by Biotrial. FDA will learn as much as possible about BIA 10-2474 and the results of the French Phase I study.

BIA 10-2474 is reported to be an inhibitor of fatty acid amide hydrolase (FAAH), an enzyme involved in cell function in the nervous system. FAAH inhibitors have been studied for their potential therapeutic use in a number of neurological disorders. This week’s tragedy in France is the first human fatality following exposure to an FAAH inhibitor.