Biogen, Eisai throw out remaining Alzheimer's BACE hope

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Biogen and Eisai's last major, late-stage attempt at stopping Alzheimer’s using a BACE inhibitor has ended up on the trash pile. This comes after the Data Safety Monitoring Board raised safety concerns over the drug. (Biogen)

One of the last major, late-stage attempt at stopping Alzheimer’s disease (AD) using a BACE inhibitor has ended up on the trash pile with so many others.

Earlier this year, Biogen and partner Eisai canned the remaining phase 3 trial of aducanumab, their anti-amyloid asset aimed at AD, effectively killing off the program after it turned out to be a dud.

This came after much hype and expectation that it could be a pivotal treatment in treating the memory-wasting disease. There was another, however: elenbecestat, a second beta amyloid drug and a BACE inhibitor from the pair they hoped (though this hope has been diminishing in recent times fter failures from Pfizer, Lilly et al) could, somehow, pick up where aducanumab had fallen.

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With more than touch of inevitability, this turned out not to be. Today, both released a joint statement saying elenbecestat, too, will now be axed as it, too, was a dud and likely unsafe.

“The decision is based on the results of a safety review conducted by the Data Safety Monitoring Board, which recommended to discontinue these trials due to unfavorable risk-benefit ratio,” the pair said.

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Dr. Lynn Kramer, chief clinical officer of Eisai’s neurology business group, said: "We would like to thank the patients and the families, as well as medical professionals, that participated in the MISSION AD studies. Without their contributions we would not be able to advance Alzheimer's disease research. We are very disappointed with the news, and intend to learn from these data and continue engaging with patients and investigators, to pursue the discovery of new medicines for Alzheimer's disease."

This sees the end of two phase 3 tests across more than 2,000 patients with mild AD as well as a phase 2 long-term extension test.

Biogen has in recent months been trying to uncouple itself from AD R&D and its reliance for future growth on it, despite spending a good few years talking up its prospects.

The company has in the past year tried to diversify outside of its focus on aducanumab, recently delving into gene therapies with its $877 million Nightstar buy, but these AD drugs were a central pipeline asset for the big biotech.

Eisai said it would however keep going with yet another AD hopeful, the anti-amyloid BAN2401, which is also in phase 3.

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