Drug Development, R&D

J&J axes its big BACE program in asymptomatic Alzheimer’s patients as the drumbeat of PhIII failures rolls on

Researchers at J&J $JNJ have pulled the plug on yet another BACE program for Alzheimer’s.

Unlike Merck, which scrapped their leading BACE program for verubecestat after it clearly failed to help patients on cognition and function in a major Phase III study, J&J was forced to halt the Phase IIb/III trial of atabecestat (JNJ-54861911) after some of the patients in the drug arm began to demonstrate serious spikes in liver enzymes.

Merck’s study was a classic pivotal attempt to bend the curve of the erosion of cognition and function among patients suffering from what’s been defined as an early stage of the disease, with symptoms of an ailment that is wiping the memories of millions of patients around the world. And it was a classic failure, joining a long and growing list of late-stage pratfalls despite doing what the researchers expected it to — halting the flow of amyloid beta into the brain.

J&J’s study, though, was one of several that want to see if the BACE approach can work in preventing the onset of the disease in asymptomatic patients. They launched their main study — alongside a longterm safety trial — back in the fall of 2015. Investigators had treated more than 600 people with an eye to completing a marathon trial that would stretch out to 2024, eventually including 1650 subjects.

J&J had good reason to be leery of tox. Eli Lilly had to scrap their initial BACE effort in 2013 for the same reason, and Vitae Pharma and Boehringer Ingelheim’s BI 1181181 was suspended two years later due to skin rashes.

Eli Lilly later went on to in-license AstraZeneca’s BACE drug, paying to jockey it into a Phase III trial for symptomatic patients. But a host of analysts are shaking their heads over its prospects now that Merck has offered some compelling evidence to show that strategy is a non-starter.

Alzheimer’s has tested the patience and budgets of a large group of pharma giants and biotechs. Pfizer executed one of the more recent exits, axing a group of 300 in the process. And Axovant shares were shredded after its unsurprising collapse. Still, new players like Celgene and Denali have been expanding their pipelines in a hunt for a drug that can help patients. Anyone who’s successful, even marginally, will have a big league blockbuster on their hands. But the odds against it are daunting.


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