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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