Johnson & Johnson’s Janssen Biotech said it will halt two clinical studies assessing its Alzheimer’s disease candidate atabecestat (JNJ-54861911), citing an unfavorable risk-benefit profile for the Beta-amyloid cleaving enzyme (BACE) inhibitor.
Janssen said it will stop screening, randomization and dosing of atabecestat in its Phase IIb/III EARLY trial ( NCT02569398 ) assessing the drug in late-onset preclinical-stage Alzheimer’s, as well as in a Phase II European long-term safety study ( EudraCT Number 2014-004274-41 ).
Both studies began in 2015, with the EARLY trial having an estimated primary completion date of April 10, 2024.
“Elevations of liver enzymes, which were serious in nature, have been observed in some study participants who received the Janssen BACE inhibitor, atabecestat,” Janssen said in a statement last night. “After a thorough evaluation of all available liver safety data from our studies, Janssen has concluded that the benefit-risk ratio is no longer ...