2016s worst clinical trial failures

Days after a phase 1 clinical trial studying an experimental fatty acid amide hydrolase (FAAH) inhibitor being developed by the Portuguese company Bial-Portela left one patient dead and five others hospitalized in France, numerous questions remain unanswered, according to an article on the BioSpace website.

FAAH inhibitors are designed to break down endocannabinoids, including anandamide, in the brain and are being investigated for use in the treatment of chronic pain. These molecules activate cannabinoid receptors—the same ones that bind THC, the key component of cannabis, an article in Science magazine said. BIA 10-2474, the drug tested at the French facility, is designed to inhibit FAAH, thereby slowing the breakdown of endogenous cannabinoids, which might help fight pain, the magazine said.

The drug was administered to 108 patients, but only six were negatively affected, which leads to the unanswered question of “why.” Stephen Alexander, a molecular pharmacologist at the University of Nottingham in the United Kingdom, told Science that it’s possible BIA 10-2474 had “unexpected effects because it binds to another target besides FAAH.” It also could have been a dosing accident, another pharmacologist told the magazine.

FAAH inhibitors are being studied by other pharmaceutical companies. Janssen is developing an FAAH inhibitor for social anxiety disorder, while Merck and Pfizer are developing FAAH inhibitors for the treatment of osteoarthritis pain, insomnia, Tourette syndrome, and cannabis withdrawal, Forbes reported.

Initial press reports said BIA 10-2474 was cannabis based, but it turned out to be a drug aimed at targeting the body’s cannabinoid system. Seth Yakatan, chief executive officer of Kalytera Therapeutics, a California company developing cannabinoid-based drugs for the treatment of obesity and osteoporosis, said he has spent a lot of time dispelling rumors about the Bial drug. Because of the inaccuracies being reported, Yakatan said it was important to quell any relationship between the Bial trial and cannabis-based therapeutics.

Source: BioSpace; January 19, 2016.

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