French health regulators have yet to determine exactly went wrong in a drug trial that left one volunteer dead last month, working to establish the cause of a Phase I disaster that has shaken up the drug industry.
As Reuters reports, French Health Minister Marisol Touraine said at a news conference on Thursday that her staff had identified three failings in the study, run by CRO Biotrial on behalf of drugmaker Bial, but declined to specify what the issues were.
"It's not possible to identify the direct causes of the accident," she said, adding that the 5 patients hospitalized after the trial are improving, according to Reuters.
Bial's drug, which blocks the enzyme FAAH to treat anxiety, was administered to 90 healthy volunteers in a Phase I trial that began last year. The 6 hospitalized patients joined near the end of the dose-escalating study, receiving multiple daily administrations of the drug, the company said. Investigators are now poring over Bial and Biotrial's records and screening all of the study participants to determine whether the injuries are related to the drug's mechanism of action, contaminated doses or any other misconduct.
The issue has put a spotlight on FAAH, a seemingly well-understood drug target. Short for fatty acid amide hydrolase, FAAH helps regulate the body's cannabinoid receptors, making it a seemingly promising target for the treatment of pain and anxiety. But the Bial trial has led some drugmakers to reexamine its safety.
Last month, Johnson & Johnson ($JNJ) voluntarily paused studies on an FAAH blocker in development for major depressive disorder and social anxiety. The company said it planned to keep the program on hold until more details from the Bial study come to light, noting that it hasn't seen any reports of serious side effects tied to its drug.
Pfizer ($PFE), Sanofi ($SNY) and Vernalis have all invented and abandoned FAAH drugs in the past, but none of those decisions were related to safety, the companies said.
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