BIA 10-2474
BIA 10-2474 is an experimental fatty acid amide hydrolase (FAAH) inhibitor that was developed for the treatment of various medical conditions, including pain and anxiety. The compound gained significant attention due to a clinical trial in France that resulted in severe adverse effects, including one death.
Development
BIA 10-2474 was developed by the Portuguese pharmaceutical company Bial. The drug was intended to inhibit the enzyme FAAH, which is involved in the degradation of endocannabinoids such as anandamide. By inhibiting FAAH, BIA 10-2474 was expected to increase the levels of endocannabinoids, potentially providing therapeutic benefits for conditions like chronic pain, anxiety, and neurodegenerative diseases.
Clinical Trial
In January 2016, a Phase I clinical trial of BIA 10-2474 was conducted in Rennes, France. The trial was managed by the contract research organization Biotrial. The study aimed to assess the safety, tolerability, and pharmacokinetics of the drug in healthy volunteers.
Adverse Effects
During the trial, several participants experienced severe neurological symptoms. One participant was declared brain-dead and subsequently died, while others were hospitalized with serious neurological damage. The trial was immediately suspended, and an investigation was launched by French health authorities.
Investigation and Findings
The investigation revealed that the adverse effects were likely due to off-target effects of BIA 10-2474. The exact mechanism of toxicity remains unclear, but it was suggested that the drug might have interacted with other enzymes or receptors in the brain, leading to the observed neurotoxicity.
Impact and Aftermath
The incident had a significant impact on the field of drug development, particularly concerning the safety of first-in-human trials. It led to increased scrutiny and regulatory changes aimed at improving the safety of early-phase clinical trials.
See Also
References
External Links
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