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French safety authority confirms what had been speculated--Phase I volunteers received the fifth of the highest dose escalation of the investigational drug at the same time, which goes against EMA recommendations.
The French national drug safety agency (ANSM), released the timeline of events (downloadable in English) for the Phase I clinical trial of BIA 10-2474, and it confirms what had been speculated, that the eight healthy volunteers received the fifth of the highest dose escalation (50 mg) of the investigational drug at the same time. This goes against EMA recommendations released in 2007, to address failures of a 2006 Phase I trial conducted in the UK, that specifically stated that trials be designed with “sequence and interval between dosing of subjects within the same cohort,” among other ways to help mitigate risk.
The Phase I trial contracted by Portuguese pharma company Bial to CRO Biotrial was conducted in Rennes, France. The ANSM document outlines that after the eight received their doses, one was hospitalized that evening. The remaining seven then received the sixth dose the next morning. The eighth man succumbed to a coma that day. Biotrial and Bial then discontinued the trial and notified ANSM, three days later. In the interim, five additional participants were hospitalized and now MRIs are indicating brain injuries to four of them.
On January 22, the FDA announced it would work with the EMA and ASNM to learn more about the safety issues around BIA 10-2474, a fatty acid amide hydrolase (FAAH) enzyme inhibitor. Additionally, the regulatory authority is in the process of collecting and reviewing safety information pertinent to FAAH inhibitors under investigation in the United States.
Read more on this trial from Medscape as well as a report we provided January 19.