First, the caveats: in June of 2013, we reported on Lilly’s β-amyloid inhibitor drug candidate — LY-2886721 — as Lilly stopped its studies for Alzheimer’s, due to a safety signal in the livers of study participants. [Baxter had earlier seen a similar (but not one-for-one) flame out.]
Given this morning’s announcement, though, it would seem likely tht a class-wide side effect will not be seen in the livers of patients on the Merck candidate, MK-8931. That this BACE inhibitor is not showing the emergence of a class-wide effect is very good news for Mr. Frazier. Now, it is time to complete the small study, and move on to much larger trials.
And so, this candidate is still perhaps about four years from being on market in the United States, even if all goes as planned from this point forward. I am aware that my timeline is slightly longer than Whitehouse Station’s. But I suspect that there will be (as there invariably are) one or two hiccups along the way. Here is Merck’s press release — and a snippet, from it:
. . . .[Whitehouse Station] provided an update on the development program for MK-8931, a novel investigational oral β-amyloid precursor protein site-cleaving enzyme (BACE) inhibitor. The Data Monitoring Committee (DMC) for the Phase II/III “EPOCH” study in patients with mild to moderate Alzheimer’s disease recently completed its planned interim safety analysis and recommended that the trial continue to recruit patients, with no changes to the protocol.
The DMC recommendation was made following a planned analysis of interim safety data that included a safety cohort of 200 patients treated with MK-8931 for at least 3 months. Based upon the DMC’s recommendations, Merck will continue enrollment of the EPOCH study. In addition, Merck will initiate dosing in a new Phase III study (APECS study) evaluating MK-8931 in patients with amnestic mild cognitive impairment due to Alzheimer’s disease, also known as prodromal Alzheimer’s disease.
“We are pleased to receive the DMC’s recommendation and look forward to continuing the clinical development program for MK-8931,” said Dr. David Michelson, vice president, Neuroscience, Merck Research Laboratories. “Studies to evaluate potential new treatment options are critical as the global health and financial burden of Alzheimer’s disease grows. . . .”
Yes, this is decidely good news. We will keep an eye on this — as it could be very a very important Merck product launch, come late 2018, or so.