Btobioinnovation.com

Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #19.27

Dear Readers,

We had a very long summer break and we are now resuming our editorial activities with a special report dedicated once again to a major failure of an Alzheimer’s drug.

Is this Setback the Last Nail in the Amyloid-beta Coffin?

On September 12, both Biogen and its partner Eisai, have announced the stopping of the development of elenbecestat, a BACE (beta-secretase) inhibitor for the treatment of Alzheimer’s disease.  “The decision is based on the results of a safety review conducted by the Data Safety Monitoring Board (DSMB) which recommended to discontinue these trials due to unfavorable ris-benefit ratio” according to a statement by Biogen.

Earlier this year Biogen and Eisai had already stopped the late stage development of aducanumab, their first BACE inhibitor aimed at Alzheimer’s disease and at the time analysts were already wondering why both partners would continue the development of elenbecestat, giving it vitually no chance of success.

A few months ago, CNP520, or umibescestat, a selective BACE1 inhibitor developed jointly by Amgen and Novartis, had been stopped because of a worsening rate of cognitive decline in patients taking the drug.

For almost 30 years, BACE inhibition which has been selected as a valuable target for lowering the production of amyloid beta and many selective inhibitors had been selected to undergo clinical trial. Unfortunately, this approach has been the most disproven approach in all of Alzheimer’s disease R&D programs with failures of Phase III drugs from Amgen, AstraZeneca, Biogen, Eisai, Eli Lilly, Johnson & Johnson, Merck and Novartis. 

In a recent coverage of the BACE saga, John Carroll from EndPoints wrote” This failure adds to the weight of evidence, that the amyloid-beat appraoach to treat Alzheimer’s disease with a monotherapy – dominant for the past two decades – is wrong.

In a rought estimate, we consider that at least $ 10 billion have been invested in the BACE approach by the biopharmaceutical companies.

You can always get in touch with me, at the following email. There are no filters and no gatekeepers, I just hope you enjoy this coverage.

Jean-Claude Muller  jcm9144@gmail.com

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