Proof of Concept Behind Neuroprotective Agent NA-831 and Lecanemab for Alzheimer Disease: Lloyd Tran, PhD

WATCH TIME: 7 minutes

"We think that by targeting the brain with two pathways, there is more potential benefit than risk. That’s our hypothesis... One targets amyloid, the other targets neurogenesis—can both benefit the patient? This is something we can find out in the clinical trials."

Even as novel therapeutics for Alzheimer disease (AD) are starting to bloom, there is still a wide consensus among clinicians that treating the disease will take a multimodal approach, with a combination of different targeted treatments. To date, there are 2 FDA-approved antiamyloid treatments on the market, lecanemab (Leqembi; Eisai) and donanemab (Kisunla; Eli Lilly).

At the recently concluded Alzheimer’s Association International Conference (AAIC), held July 28-August 1 in Philadelphia, Pennsylvania, investigators from Biomed presented the design of a new phase 3 study assessing NA-831, an investigational small molecule agent, with lecanemab, in patients with early-stage AD. Comprised of a core study and open-label extension, the trial program is expected to include 600 participants aged 50 to 90 years who will be randomly assigned to either one 30 mg of NA-831 capsule once a day or placebo, intravenous lecanemab (10 mg per kilogram of body weight every 2 weeks) or placebo, or 1 30 mg of NA-831 capsule orally once a day and intravenous lecanemab (5 mg per kilogram of body weight every 2 weeks) or placebo.

NA-831’s mechanism of action is based on neurogenesis, directly related to restoring memory loss and improvement of cognitive functions. Thus far, the drug has shown an ability to cross the blood brain barrier with great bioavailability, and is safe, with no toxicity observed.

During the meeting, Lloyd Tran, PhD, chairman and chief executive officer at Biomed, sat down to discuss the mechanism of action of NA-831 and the hypothesis behind the study. He gave a brief overview of lecanemab’s limitations and the potential synergistic effects the company believes it can show between the 2 drugs. Additionally, he touched on the importance of neurogenesis, research on the role of hippocampus in AD, and its effects on cognitive decline. Lastly, he provided further comment on the rationale behind combination approaches in neurology and why it hasn’t been done before.

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REFERENCE
1. Tran L, Tran ZV, Vu F, et al. Phase 3 clinical protocol: placebo-controlled, double-blind, parallel-group to study safety and efficacy of NA-831 in combination with lecanemab in subjects with early Alzheimer’s disease. Presented at: AAIC; July 28-August 1, 2024; Abstract 95755