Merck makes Alzheimer’s deal
pharmafile | March 14, 2013 | News story | Research and Development, Sales and Marketing | Alzheimer's, Merck
Merck is teaming up with Texas-based Luminex Corporation to develop a companion diagnostic to help in its dementia programme.
The idea is to find a test to support recruitment into the development of Merck’s lead candidate in Alzheimer’s disease modification, MK-8931, an investigational oral BACE inhibitor.
No financial details were disclosed, but the two companies will seek a device to help screen patients with mild cognitive impairment (MCI), for increased risk of developing the degenerative brain condition.
Merck is set to carry out a global, multi-centre Phase II/III clinical trial, EPOCH, to evaluate the safety and efficacy of MK-8931 versus placebo in patients with mild-to-moderate Alzheimer’s.
Phase I studies suggested the drug reduces levels of beta amyloid in cerebral spinal fluid (CSF) by more than 90% in healthy volunteers and in sufferers, without dose-limiting side effects.
“This collaboration has the potential to deliver a novel companion diagnostic to identify patients at increased risk,” said Luminex president Patrick Balthrop.
Luminex’s part of the deal will be to develop, submit and commercialise the candidate device, which will use the company’s xMAP technology.
This measures concentrations of two possible biomarkers – Aβ42 and t-tau – in CSF samples from patients with MCI.
The cause of the disease is unknown, but build-up of beta amyloid in the brain is a key indicator of Alzheimer’s, and researchers believe measuring these may be useful in identifying patients at greater risk.
Beta amyloid precursor protein site cleaving enzyme (BACE) is believed to be a key enzyme in the production of beta amyloid peptide, which contributes to the formation of plaques in the brain.
Inhibiting BACE is thought to decrease the production of beta amyloid and may therefore reduce plaque formation and modify disease progression.
“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 Schoepp, head of neuroscience and ophthalmology at Merck Research Laboratories.
At present the disease is diagnosed by clinical examination and MRI or CT scans, with diagnosis only confirmed by investigating post-mortem brain samples.
Adam Hill
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