Of Concern? Lilly’s BACE Inhibitor Candidate Drug — For Alzheimer’s — Shows Liver Toxicity

UPDATED | 06.14.13 @ 1 PM EDT: My buddy, Ed, this time writing for Forbes, has amplified my small observations — and collected some great additional Merck-related detail, from on the record sources, here. Do go read his. [End, Updated portion.]

Let’s hope that Lilly’s drug candidate — LY-2886721 — is not showing the emergence of a class-wide effect.

Overnight, Eli Lilly, in Indy, announced that it was stopping work on its BACE inhibitor candidate for Alzheimer’s, due to a safety signal in the livers of study participants. The patients showed some liver toxicity while on the drug. [Previously, in other classes, both Lilly and Baxter have seen drug candidate flame-outs, chasing the elusive white whale — an Alzheimer’s cure. But the rewards would be vast, should any of these majors harpoon the fearsome Moby Dick.]

And so, recall now that Merck has an Alzheimer’s beta-amyloid pathway (or BACE inhibitor) candidate in mid-stage trials, called MK-8931, as well.

While both Lilly’s drug candidate, and Merck’s, are of the same basic class, it is often the case that subtle variances in the composition/structure of the chemicals turn out to be responsible for these “off-target” effects. Let’s hope that is so, here. I continue to applaud Mr. Frazier and Dr. Perlmutter for taking these “big science” (i.e., big risk; big reward) projects forward. This is how the face of Alzheimer’s medicine will change — with some great leap forward — acheived by some bold risk-taking CEO and science team.

Here’s a bit of the Lilly story — do go read it all, at Bloomberg:

. . . .Lilly ended the trial of the therapy, called LY2886721, after participants showed abnormal liver biochemistry, the Indianapolis-based company said today in a statement. The drug was in the second of three phases of clinical trials typically required before regulatory approval and was being tested in about 150 patients, the company said.

“Lilly will further evaluate this data prior to determining next steps for the entire LY2886721 clinical development program,” the company said.

The drug was in a category called beta secretase, or BACE, inhibitors. Merck is developing a drug in the same class. The therapies help prevent the formation of plaque tangles in the brain called beta amyloid, which is associated with Alzheimer’s. . . .

Finally, recall that Merck is working with Luminex to develop a companion diagnostic panel for the ultimate commercialization of its BACE inhibitor program (thus the file graphic at right — I don’t have time to create a custom Lilly-Merck graphic for this story).


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