Merck ($MRK) is pressing forward with its controversial Alzheimer's treatment, and now it has signed a deal with Luminex ($LMNX) to develop a companion diagnostic that will screen patients for its ongoing clinical program.
The blockbuster hopeful MK-8931 is designed to block an enzyme that helps produce beta amyloid peptide, believed to trigger Alzheimer's. Merck is in the midst of a Phase II/III trial of the drug, and Luminex's job is to craft and get approval for a diagnostic that will track two biomarkers in patients' cerebrospinal fluid, identifying those at risk for Alzheimer's who might benefit from MK-8931.
The resulting test will use Luminex's xMAP diagnostic platform, and, if the drug is the success Merck says it will be, the deal could be a major boon to Luminex's presence in the companion diagnostic world.
"This collaboration has the potential to deliver a novel companion diagnostic to identify patients at increased risk of developing Alzheimer's disease," Luminex CEO Patrick Balthrop said in a statement. "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."
The deal follows Merck's licensing of GE Healthcare's ($GE) flutemetamol, a beta amyloid-detecting imaging agent that can identify the Alzheimer's footprints in PET scans. Merck is using GE's investigational agent to identify patients for its ongoing trial, too, but the company hasn't decided whether it'll use flutemetamol as a companion diagnostic down the road.
Merck's commitment to MK-8931 has raised some eyebrows in the biotech world, as competitors Eli Lilly ($LLY) and Bristol-Myers Squibb ($BMY) have endured failures with similar therapies. The Phase II/III study is enrolling patients with mild to moderate Alzheimer's, which, as John Carroll points out in FierceBiotech, is much of the same population that failed Lilly and Bristol.
But Merck has faith in its treatment and confidence in its biomarkers, and if Luminex can come through with a diagnostic that helps recruit the patients most likely to succeed with MK-8931, the drugmaker could triumph where its contemporaries have periled.
- read the announcement