Expert: How Lomecel-B Stands Out in the Treatment of Alzheimer Disease

During the 2024 Alzheimer's Association International Conference (AAIC), Pharmacy Times interviewed Joshua Hare, MD, FACC, FAHA, co-founder, chief science officer, and chairman at Longeveron, on the phase 2a CLEARMIND (NCT05233774) clinical trial results. In this interview, Hare discusses how Lomecel-B differs from other treatments currently available for Alzheimer disease (AD) as well as his biggest takeaway from the study.

Pharmacy Times: How do cellular therapies, and specifically Lomecel-B, differ from currently available treatments for AD (i.e. lecanemab and donanemab)?

Joshua Hare: So, it's been very difficult to develop a disease-modifying drug for Alzheimer disease (AD). And it's only in the last year that we've seen approval of the monoclonal antibodies that remove amyloid from the brain. The one approval was just within the last month or 2. So the monoclonal antibodies that reduce the amyloid in the brain are considered to be what we would call disease-modifying drugs, but if you look at the clinical results, they slow the acceleration of cognitive decline. They also have a side effect profile. So there's a real need to develop other classes of drugs that address different mechanisms of action. Lomacel-B (Longeveron) addresses a completely novel mechanism of action. It's addressing neuroinflammation as opposed to amyloid deposition.

Pharmacy Times: What is your biggest takeaway from the CLEARMIND trial (NCT05233774) results?

Hare: So, like in many other chronic diseases that we've had success in treating over the many decades, I see a future where treating physicians will use not just 1 class of medicine for AD but different classes of therapy in combination. And I think we will see that here as we develop a new class of drugs that addresses a novel mechanism of action for AD.

The biggest takeaway from the trial is that we have advanced the safety profile of Lomecel-B from single to multiple dosing. We met our pre-specified composite clinical end point, and we developed a larger database of other specific end points in the cognitive area, in the brain imaging area, and in the activities of daily living domain. This data is incredibly valuable for us as we design and power the next phase of trials.

So, the key takeaway was that we have a consistency of outcome metrics and multiple domains that help us in our understanding of mechanism of action, and in the design of future trials.