Merck & Co. enters collaboration with Luminex to develop companion diagnostic for experimental Alzheimer's disease drug

Merck & Co. announced Wednesday a collaboration and license agreement with Luminex to develop a companion diagnostic device to help screen patients for recruitment into Merck's clinical programme for the experimental Alzheimer's disease drug MK-8931, an oral BACE inhibitor. "Evaluation of biomarkers that may provide an indicator of disease onset and enable earlier diagnosis is an important goal toward facilitating early intervention and potentially improving the treatment of Alzheimer’s disease," said Darryle D. Schoepp, head of neuroscience and ophthalmology at Merck Research Laboratories.

In an early-stage trial, results showed that MK-8931 can reduce levels of beta amyloid in cerebral spinal fluid (CSF) by more than 90 percent in healthy volunteers and those with Alzheimer's disease without dose-limiting side effects. Based on the findings, Merck is conducting a Phase II/III trial called EPOCH to evaluate the safety and efficacy of MK-8931 versus placebo in patients with mild-to-moderate Alzheimer's disease. The drugmaker is also planning to initiate a study in prodromal subjects.

The companies noted that recent clinical evidence suggests that measuring beta amyloid 42 and t-tau in CSF may be useful in identifying patients at greater risk of developing Alzheimer's disease. Under the agreement, Luminex will be responsible for the companion diagnostic device's development, regulatory submission and commercialisation. The device will employ Luminex' xMAP Technology to measure the concentrations of beta amyloid 42 and t-tau in patients with mild cognitive impairment and will be evaluated as a means to identify subjects who have a higher risk of developing Alzheimer's disease to support patient selection for Merck’s clinical studies. Financial terms of the deal were not disclosed.

In December, Merck and GE Healthcare announced a clinical study collaboration, license and supply agreement for use of the investigational positron emission tomography imaging agent [18F]flutemetamol to support development of MK-8931.

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