Cerveau Technologies said today that the FDA cleared the investigational new drug application for its tau imaging agent.
The company plans to work with pharmaceutical partners to evaluate the product’s use in positron emission tomography scans to assess neurofibrillary tangles in the brain. NFTs composed of aggregated tau protein are characteristic of certain neurodegenerative conditions like Alzheimer’s disease.
“We are pleased to reach this important milestone in the development of our novel, next-generation agent for the detection and quantitation of NFT in patients,” president Rick Hiatt said in prepared remarks. “We believe that it validates the faith our pharma partners have placed in us. Clinical studies will proceed to determine the ability of MK-6240 to stage disease and quantify the potential effects of therapeutic treatments for neurodegenerative disease, including Alzheimer’s disease. We are excited to work with our current collaborators as well as other partners to develop this agent as a potential biomarker for staging patients, and monitoring their therapy throughout treatment.”