Merck Has Been Enrolling Mild To Moderate Alzheimer’s Patients — In MK-8931 Phase II Study Since December 2012

And so, it makes sense that, as of Wednesday, Merck had signed up a collaboration and license agreement with Luminex, to allow Luminex to build a companion diagnostics device — one dedicated to measuring the levels of two candidate biomarkers (Aβ42 and t-tau) in cerebrospinal fluid samples from likely Alzheimer’s patients with mild to moderate cognitive impairment.

The goal of creating such a device, of course, is to quickly assess whether a given likely Alzheimer’s patient is a suitable candidate for the now-enrolling Phase II clinical trial — and to establish baseline (and post treatment) levels of the two biomarkers.

Here is a bit of yesterday’s press release on the matter:

. . . .Luminex will be responsible for development, regulatory submission and commercialization of the candidate companion diagnostic device, which will employ Luminex’s xMAP® Technology to measure concentrations of two candidate biomarkers (Aβ42 and t-tau) in cerebrospinal fluid (CSF) samples from patients with mild cognitive impairment (MCI). The candidate device will be evaluated as a means to identify subjects with MCI who have a higher risk of developing AD to support patient selection for Merck’s therapeutic BACE inhibitor clinical program.

“This collaboration has the potential to deliver a novel companion diagnostic to identify patients at increased risk of developing Alzheimer’s disease,” added Patrick J. Balthrop, president and CEO of Luminex. “We are pleased to leverage our technologies and development capabilities and look forward to expanding our activity into the companion diagnostic segment of personalized medicine. . . .”

This is the sort of bold risk Mr. Frazier said Merck would take, under his stewardship. I applaud it — with these sorts of “big science” risks, more than occasionally come big market rewards. To be sure, there will be bumps in the road, along the way — but Alzheimer’s may be one of the largest remaining great white whales in the deep blue, out there. We just know so little about it. . . This Phase II trial will likely not be completed until late 2017.

And so — here’s to the process of discovery! Let us all hope it leads to relief from the dread disease called Alzheimer’s.

We will keep you posted.

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