The Rennes-based contract research organisation (CRO) made the accusation in response to a Le Figaro article (here in French), which suggested side effects suffered by other volunteers should have prompted it to halt the trial last year.
A Biotrial spokeswoman told us the firm’s “attorneys are outraged by the smear campaign led by the national daily newspaper Le Figaro against the clinical trial center from Rennes.
“Monday evening an umpteenth article of Le Figaro brings out no new rational information when a judicial inquiry is ongoing at the same time by an expert judge from the health department of Paris court.”
According to Le Figaro, neurological side effects experienced by volunteers who received low doses of BIA 10-2474 during earlier stages of the trial should have prompted Biotrial to halt the study before dosing in the high dose group began.
The Biotrial spokeswoman told us “We object to this article and to previous ones as the journalist is building up conclusion and making big titles with almost nothing tangible and no new information, the newspaper is behaving like a judge where as one is working on our case right now, so we’d just like to let the justice do its work and we are waiting for their conclusions, not the Figaro’s one.
“The article is written to entertain confusion and use part of truth to build its own and very personal truth.”
French authorities are still investigating the trial. In May, France’s social affairs inspectorate (IGAS) criticised Biotrial over how it conducted the study, including its decision to administer BIA 10-2474 to patients in the high dose cohort after the first volunteer was hospitalised.