Results, Setbacks

Looking for an early success in PhII Alzheimer’s study, Biogen and Eisai just racked up the latest setback

Chalk up another big setback for the amyloid beta theory and another failed attempt at blazing a clinical path to success.

Investigators for Biogen $BIIB and Eisai say that their anti-amyloid beta antibody BAN2401 flunked the 12-month primary endpoint in their Phase II study. They had hoped that using Bayesian analysis methods would set them up for an early win, based on a new goal for success using a composite disease score with the patients enrolled. Now they will go on to the full 18 month mark and then run a check of biomarkers for the disease — which has proven to be a remarkably unreliable assessment for clinical efficacy.

Biogen shares dropped more than 4% this morning.

Lynn Kramer, Eisai

Still, the biotechs aren’t giving up, holding out hope that they can move into late-stage testing — a mine field for companies in the space which no one has successfully navigated in the past 15 years.

The notion that eliminating the toxic tangles seen in many, though not all, patients diagnosed with this memory-wasting disease has cost billions of dollars of research cash in recent years. Eli Lilly tried and failed with solanezumab three times, and still has work ongoing. Merck recently failed on the first step with their BACE approach and Vivek Ramaswamy’s Axovant tanked after they took another failed approach on a different strategy for amping cognition.

With the potential earnings from any success generally ranking in the billions, though, don’t look for anyone in the field to slow down or stop.

Biogen and Eisai are allied on three different therapies for Alzheimer’s, with the late-stage aducanumab and the BACE drug E2609 included in the package.

For it to be considered a success at 12 months, the data would need to demonstrate a greater than 80% chance of success for seeing a greater than 25% reduction in the disease score. EvercoreISI’s Umer Raffat says that we won’t really know about the result until we get to 18 months, and then he expects to see it move ahead into late-stage studies.

“By using Bayesian statistics in this uniquely-designed trial we had hoped that it would enable us to demonstrate clinical success faster than more traditional study designs. We now await the final study analysis which will be conducted after 18 months of treatment, which represents an amount of treatment time that is considered as appropriate for assessing efficacy in disease modifying agents for Alzheimer’s disease,” said Lynn Kramer, Eisai’s R&D chief for neurology.

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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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