During tests carried out on animals, the molecule (entitled BIA 10-2474, aimed at treating mood and anxiety disorders, and motor disorders, linked to neurodegenerative diseases) implicated in the death of a participant in the Rennes clinical trial reportedly killed dogs. Information revealed by the daily newspaper Le Figaro.
January 15, 2016 the Biotral laboratory was on the front page. Six participating volunteers – one of whom has since died – in clinical trials were hospitalized with injuries to the base of the skull that resulted in coordination and movement disorders. One of them died as a result of this test.
After analysis of the available toxicological data, the scientific committee of the National Medicines Safety Agency (ANSM) considered that the results of the studies carried out in animals met the required prerequisites and authorized a passage to the clinical trial in man. He also considered that “the pharmaceutical quality of the product also met the requirements expected for a clinical trial”. However, the information unveiled by Le Figaro seems to point to the responsibility of the laboratory.
Shedding light on accountability during this clinical trial
“The deaths of dogs would be extremely important information. This can be a real warning signal, ”explains Daniele Piomelli, professor of neurobiology and pharmacology at the University of California at Irvine, interviewed by the daily.
“Three dogs died in a study, that means everything and saying nothing, replied on BFMTV François Peaucelle, director of Biotrial. The conclusions of these studies were sufficiently clear and sharp so that there is no particular ambiguities for a passage on the man. “
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