Then, once you have the drug, you need to see if it’s doing what you want it to do. In the case of amyloid, we’re looking to see if the drug is removing amyloid plaque, which we can measure with PET. But we can also use blood-based biomarkers to see if the treatment is having the desired effect.
But it doesn’t stop there. Once a drug is on the market, the FDA requires that we monitor the safety of the drug. And we can use blood-based biomarkers for that as well. We can see if there are any signals that might lead us to think there’s a problem before it becomes a big issue.
And finally, we’re working on companion diagnostics that could be used to identify patients who might be more likely to respond to therapy. That’s the next horizon for us, to be able to identify patients with amyloid pathology as early as possible, even before symptoms develop.
What impact do you see these advances having on patients and the Alzheimer’s community?
Right now, we’re seeing a lot of variability in patient diagnosis and treatment. We want to move towards a more structured, more informed diagnosis so we can get patients the right therapy as soon as possible. That’s the ultimate goal — to get patients on therapy before they get to the point of no return.
And the community is starting to understand that. There’s a sense of urgency now, both in patients and in providers, to get these tests done. We’ve seen the same thing in oncology, and I think we’re starting to see it in Alzheimer’s.
But the biggest impact will be on the patients themselves. If we can get these tests to patients earlier, identify them earlier, and get them on therapy earlier, we have the potential to really change the course of the disease for them. That’s why we’re so committed to this work.
Ultimately, this is about improving the lives of patients, and that’s our driving force.
What’s next for Alzheimer’s disease diagnosis and treatment at Eli Lilly?
We’re continuing to invest in biomarker research. We’re looking at new targets, new ways to measure them, and new ways to use them. We want to make sure we’re at the forefront of this field so we can continue to drive progress in Alzheimer’s disease.
And we’re also working on expanding access to these tests. We want to make sure that every patient who needs these tests can get them, regardless of where they are or who they see. Our goal is to make these tests as routine as a cholesterol test, so we can catch this disease early and treat it effectively.
It’s an exciting time to be in this field, and we’re just getting started.
In the Trailblazer-Alz 2 phase 3 trial for preclinical patients, a blood biomarker was utilized to define the study population. This innovative approach allowed researchers to assess the engagement and efficacy of the medicine being tested, rather than focusing solely on symptom progression as an ultimate outcome. Biomarkers have been extensively used in cancer research as surrogate endpoints for trial design, indicating progress and patient response to treatment. While biomarkers are not yet widely utilized in Alzheimer’s disease research, there is potential for them to serve as valuable endpoints in the future.
Lilly has made significant strides in the Alzheimer’s diagnostic space with the approval of the Lumipulse p-tau217/Aβ42 assay for early symptomatic patients. This milestone marks a crucial advancement in identifying patients with amyloid pathology before the onset of symptoms. Moving forward, the goal is to develop blood tests that can detect amyloid deposition in the brain at an even earlier stage, providing patients with the opportunity for early intervention.
Despite the availability of biomarker tests, their uptake in health systems has not been universal. Physicians may be hesitant to utilize these tests due to a lack of belief in their efficacy or limitations in current guidelines. To address this issue, continued publication of research findings, updates to guidelines, and patient education are essential to increase the utilization of biomarkers in clinical practice.
Lilly is committed to aligning diagnostic and therapeutic pathways in Alzheimer’s disease to ensure more precise treatment approaches in the future. Collaboration with partners for additional validations and approvals of biomarkers, as well as expanding access to high-quality testing globally, are key priorities. The ultimate goal is to integrate biomarker testing into routine healthcare practices, potentially making it a standard part of annual blood work for individuals over a certain age. This proactive approach to diagnostics could revolutionize the early detection and management of Alzheimer’s disease.
