Eli Lilly Quietly Scraps a BACE Program for Alzheimer’s


By Alex Keown


It seems that the sands of time are slowly running out on Eli Lillys BACE program for treating Alzheimer’s disease.

This week during its third quarter conference call, David Ricks, Eli Lilly’s Chief Executive Officer, slid in the fact that the company has scrapped a Phase II clinical trial for N3pG, a humanized IgG1 monoclonal antibody, plus BACE in the treatment of Alzheimer’s. Ricks did note that Eli Lilly was still studying N3pG as a monotherapy.

Lilly’s throwing-in of the towel on the BACE program sends a signal that a treatment for Alzheimer’s is still somewhere in the future. BACE, also known as beta-site amyloid precursor protein cleaving enzyme 1, is seen as a precursor to amyloid-beta, which is believed to be the leading cause of Alzheimer’s disease. The scrapping of this program is another setback for Eli Lilly in the ever-futile-seeming quest to develop a treatment for this dreaded form of dementia.

It was only a few months ago that Eli Lilly and its developmental partner AstraZeneca announced they had shut down two late-stage clinical trials of lanabecestat, a BACE inhibitor, for Alzheimer’s disease. The decision to shut down the trials was made following an analysis conducted by an independent data monitoring committee. The committee concluded that the primary endpoints of that trial were not likely to be met. The companies said they would continue to work together in an attempt to develop a treatment for Alzheimer’s.

Eli Lilly certainly isn’t the first company to scrap a BACE inhibitor. In February, Merck & Co. halted its APECS Phase III clinical trial that was studying verubecestat, a BACE inhibitor for treatment of Alzheimer’s disease. The decision to shutter that trial was also made following an analysis from an independent data monitoring committee. However, the reason for closing down the Merck trial had more to do with safety than efficacy. The committee said the likelihood of benefit from the drug did not outweigh the safety risks.

In addition to Merck shutting down the verubecestat program, Johnson & Johnson announced in May that it was also ending its BACE program for atabacestat. Much like Merck, Johnson & Johnson’s Janssen division said it was closing down the atabacestat trial due to safety concerns. The data showed that patients in the EARLY Phase IIb/III trial were showing elevated liver enzymes. The patients participating in that trial were considered to have preclinical Alzheimer’s disease. The EARLY trial was scheduled to conclude in 2024.

While it seems that companies are reporting multiple failures in Alzheimer’s on a near-weekly basis, the companies that have been in the thick of researching potential treatments for Alzheimer’s have stressed they are not giving up hope on developing a therapy. Biogen is still driving forward with its amyloid-plaque targeting drug, aducanumab.

Alzheimer’s and other forms of dementia are a growing healthcare concern. In the United States, Alzheimer’s disease is the sixth-leading cause of death across all ages and the fifth-leading cause of death in people over 65 years of age. By 2050, the number of global patients is expected to hit 131.5 million.



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