Upcoming Alzheimer's Therapies: Key Data Releases to Watch

Breakthrough Therapies and Novel Approaches Emerge in Alzheimer's Disease Research

The landscape of Alzheimer's disease treatment is evolving rapidly, with several pharmaceutical companies making significant strides in developing innovative therapies. Recent developments span a wide range of approaches, from repurposing existing drugs to exploring entirely new mechanisms of action.

Novo Nordisk Explores GLP-1 Agonist for Alzheimer's

In a surprising turn of events, Novo Nordisk is positioning its popular weight loss drug semaglutide as a potential treatment for Alzheimer's disease. Two Phase III studies, EVOKE and EVOKE Plus, are set to report results in September, potentially opening new avenues for GLP-1 agonists beyond metabolic disorders.

The rationale for investigating semaglutide in Alzheimer's stems from growing evidence linking insulin resistance to neurodegenerative disorders. A real-world study in October 2024 associated semaglutide use in type 2 diabetes patients with a 40% to 70% reduction in Alzheimer's diagnoses. Furthermore, recent research has shown that both semaglutide and Eli Lilly's tirzepatide correlate with lower risks of dementia and stroke.

Novo Nordisk's earlier Phase IIb data on liraglutide, another GLP-1 agonist, demonstrated an 18% slowdown in brain function decline compared to placebo in mild Alzheimer's patients. While the exact mechanism of action in Alzheimer's remains unclear, these studies could shed light on the relationship between metabolic function and cognitive decline.

Next-Generation Anti-Amyloid Antibodies Show Promise

Eli Lilly is advancing remternetug, a successor to its recently approved Alzheimer's drug Kisunla (donanemab). The Phase III TRAILRUNNER-ALZ 1 trial, involving over 1,600 patients with early symptomatic Alzheimer's, is expected to yield results by March 2026. This study is evaluating both subcutaneous and intravenous formulations of remternetug against placebo, primarily assessing amyloid plaque clearance.

Interim Phase I data presented in April 2023 showed that remternetug effectively lowered beta-amyloid plaques in patients with mild-to-moderate Alzheimer's-related dementia. The drug cleared plaques in 75% of patients receiving the three highest doses, although some patients developed amyloid-related imaging abnormalities (ARIA-E).

Meanwhile, ProMIS Neurosciences is developing PMN310, a humanized IgG1 monoclonal antibody targeting soluble amyloid-beta oligomers. The company believes this approach could maximize efficacy and safety by avoiding interaction with amyloid-beta monomers and plaques. Phase Ia results presented in October 2024 demonstrated that PMN310 was generally well-tolerated and could cross the blood-brain barrier. ProMIS anticipates releasing interim Phase Ib data in the first half of 2026.

Addressing Neuropsychiatric Symptoms in Alzheimer's

Beyond cognitive decline, pharmaceutical companies are also targeting the neuropsychiatric symptoms associated with Alzheimer's disease. Bristol Myers Squibb is repurposing its antipsychotic drug Cobenfy (KarXT) for Alzheimer's-related psychosis. The Phase III ADEPT-2 trial, involving approximately 400 patients with mild to severe Alzheimer's and moderate to severe psychosis, is expected to report results in the latter half of this year.

Cobenfy, which combines xanomeline with a muscarinic blocker, was initially approved for schizophrenia in September 2024. Its potential in Alzheimer's stems from xanomeline's historical development as an Alzheimer's treatment by Eli Lilly and Novo Nordisk in the 1990s.

In a similar vein, Neumora Therapeutics is developing NMRA-511, an oral vasopressin 1a receptor blocker, to treat agitation associated with Alzheimer's disease. The company expects to release Phase Ib data by the end of the year. Preclinical studies in marmosets and healthy human volunteers have shown promising results in regulating mood and anxiety-related behaviors.

As these diverse approaches progress through clinical development, the Alzheimer's treatment landscape continues to expand, offering hope for more effective therapies in the coming years.