NFTs made up of aggregated tau protein are a hallmark of several neurodegenerative diseases, including Alzheimer’s disease.

As part of the agreement, Cerveau will be responsible for the clinical development and commercialization of MK-6240 in return for payment of license fees, milestone payments and royalties on worldwide sales of any future marketed products. Cerveau plans to initiate a Phase III clinical program in early 2018.

“At Cerveau, we are focused on providing information and technologies to researchers and clinicians to enable the improvement of brain health,” said Rick Hiatt, President and Chief Executive Officer of Cerveau Technologies, Inc.

 “We are excited by the opportunity to work with Merck and the pharmaceutical industry in providing access to this novel imaging agent to the broader scientific community.”

“There is a critical need for sensitive biomarkers for diagnosis and monitoring of tau pathology in neurodegenerative diseases to allow for more appropriate staging of disease states, and measuring the effect of candidate disease-modifying therapeutics,” said Darryle Schoepp, vice president discovery, Merck Research Laboratories.

 “Agreements such as this represent an important platform for this field of research to realize the full potential of novel Tau imaging agents in clinical practice.”

In early studies published in the Journal of Medicinal Chemistry, Merck scientists reported that [18F]MK-6240 has a high specificity and selectivity for neurofibrillary tangles with favorable physicochemical properties and in vivo pharmacokinetics that warranted clinical investigation as a potential PET neuroimaging agent.

Merck and Cerveau are currently conducting an open-label Phase 1 study to investigate the safety and characterize the use of [18F]MK-6240 as a PET imaging agent for quantifying brain burden of neurofibrillary tangle pathology.