Drug Development

Eli Lilly sweeps the rest of the BACE work out of the pipeline following their latest major setback on Alzheimer’s

Eli Lilly has suffered through the biggest setbacks in late-stage drug development work for Alzheimer’s — piling up high-profile failures for semagacestat, solanezumab and just months ago lanabecestat after it became apparent that the BACE approach was a non-starter in symptomatic patients. Today, it’s signaling that the company is now ready to fold their hand early if it doesn’t look like they have a reasonable chance to go on to win the pot.

Out in the quarterly cleanup went a Phase II BACE combo including an antibody for N3PG. And the company also axed what was termed an SEL BACE 1 Phase I study. N3PG will continue on its own.

“There are many variabilities at play with the BACE class and recent findings from Lilly and others have challenged the BACE hypothesis,” notes a spokesperson from Eli Lilly in an email followup with me. “As a field we are still evaluating the class and will continue to have robust scientific discussions about its viability.”

Merck dealt a decisive blow to BACE with back-to-back Phase III studies in which the drug did what was expected in terms of turning the tap off on amyloid beta, the longtime culprit for a disease that wipes out memory. With clear evidence that the strategy is a non-starter, Lilly and its partners at AstraZeneca agreed to kill off their late-stage program for lanabecestat after reviewing the results to date.

But BACE isn’t quite finished yet. 

Back in early June, Eisai and Biogen claimed a significant success for their BACE drug, elenbecestat. But while the biomarker for amyloid beta reduction was hit, the researchers failed to see a statistically significant improvement in the decline of cognition. That didn’t stop them from maintaining that they had tracked a response “suggesting a delay of clinical symptom decline in exploratory endpoints.”

It wasn’t exactly a big win, raising fresh doubts for two companies that continue to have a big stake in the amyloid beta theory.

Eisai and Biogen have had their hands full defending their data on a different drug, BAN2401, after a changeup in the study design drew a host of critics suggesting that they had tilted the trial toward a positive outcome. And the critics haven’t backed off after a recent attempt to defend those results.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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