Future Plans for Lantheus’ Next-Generation Amyloid-ß PET Imaging Agent NAV-4694

Alzheimer disease (AD) stands out as the most prevalent neurodegenerative disease, accounting for approximately 60% to 70% of all dementia cases. Over the years, the understanding of the underlying process of AD has improved. It is widely known that there are 2 pathological features in the brain of those with AD: extracellular senile plaques composed of amyloid-ß deposits and intracellular neurofibrillary tangles formed by hyperphosphorylated tau protein. In addition, those with AD experience brain atrophy, neuronal loss, synaptic dysfunction, and glial cell activation.

As the population ages, the need for tools to accurately detect AD at the earliest stages remain critical. Earlier this month, Lantheus, a radiopharmaceutical-focused company, announced its acquisition of Meileur Technologies, which includes NAV-4694, an amyloid-ß PET imaging agent. NAV-4694 is currently in phase 3 development and is also being used in academic and industry investigational therapeutic trials. With the acquisition, Lantheus is responsible for providing an upfront payment as well as potential additional development and commercial milestone payments.

Following the announcement, a spokesperson from Lantheus provided comment on the promise behind this agent, and how it will be used in combination with the company’s other next-generation F18-labeled PET agent candidate, MK-6240. Furthermore, they described the importance of such tools and how they will aid in the early detection of AD going forward.

NeurologyLive: How does NAV-4694 operate? Describe some of its clinical advantages/benefits

NAV-4694 (Flutafuranol) is a late-stage investigational ß Amyloid PET imaging agent targeting Beta Amyloid plaques, a neuropathological marker that is a core characteristic of Alzheimer’s disease pathology. Flutafuranol complements Lantheus’ existing portfolio, adding another precision imaging tool with the potential to aid in diagnosis, staging and monitoring of Alzheimer’s disease.

How does it differ from MK-6240? Can they be used in combination?

We see a need for options and believe each agent can aid in more accurate diagnosis, better disease staging and monitoring the impact of treatments. NAV-4694 (Flutafuranol) targets beta-amyloid plaques, while MK-6240 (Florquinitau) targets Tau neurofibrillary tangles. Having a best-in-class PET tracer portfolio for both Tau and Beta Amyloid will benefit patients and provide HCPs with the tools to optimize patient selection and monitoring of disease-modifying therapy (DMT).

In this pivotal time within the Alzheimer field, how will amyloid-ß PET imaging agents be used to better diagnose and treat patients earlier?

As noted in our press release, recently published updated guidelines developed by a working group of the National Institute on Aging and the Alzheimer's Association (NIA-AA) state that Alzheimer’s disease should be defined biologically, using protein-based biomarkers. These guidelines recommend that biomarkers, including both amyloid- and tau-PET imaging, may be used to diagnose Alzheimer's disease and provide an indication of its severity. We believe that NAV-4694 (flutafuranol) and MK-6240 (florquinitau) are both next generation PET diagnostics for patients with Alzheimer’s disease and could provide crucial insights for diagnosis, disease staging and monitoring.

Provide an overview of the phase 3 development of NAV-4694 and where we currently stand.

NAV-4694 (Flutafuranol) is currently in Phase 3 development and is also being used in academic and industry trials evaluating investigational therapeutics. During the clinical development of NAV-4694 (flutafuranol), several clinical trials were started, including an autopsy study. We will provide updates on our regulatory plan and timeline in due course.