Upcoming 2024 Alzheimer's Treatment Milestones

After years of challenges, the Alzheimer's treatment landscape is poised to introduce two new therapeutic options. Biogen and Eisai's Leqembi received full regulatory approval in July last year, and a similar endorsement for Eli Lilly's donanemab is anticipated soon, following the company's guidance of a decision by the end of 2023.

The journey for anti-amyloid therapies has been tumultuous, especially after Aduhelm's controversial approval in 2021. Biogen has since ceased sales of the contentious therapy and halted the post-approval study. Despite these setbacks, several firms are advancing their experimental drugs towards commercialization.

Graig Suvannavejh, a senior analyst in biopharmaceuticals and biotechnology equity research at Mizuho Americas, stated that the field of Alzheimer's treatment is still in its infancy. Many of the drugs in development are targeting specific aspects of the disease, such as TREM2 and the HGF system. Suvannavejh suggested that a combined approach, similar to those seen in oncology, is likely the future direction for this sector.

Here are the highlights of five Alzheimer's therapeutic assets with anticipated data releases in 2024 that excite Suvannavejh:

Alector/AbbVie’s AL002: Alector Therapeutics' AL002 is a monoclonal antibody targeting TREM2, which is linked to the onset of Alzheimer's and other dementias. The antibody is in Phase II trials, with results expected in the fourth quarter of 2024 that could shape the therapy's future. AbbVie has the option to advance to Phase III if the data are promising.

Athira Pharma’s fosgonimeton: This novel therapy is designed to regulate the HGF system, activating neuroprotective and anti-inflammatory pathways. Despite an initial setback in a Phase II trial for Parkinson's disease dementia, a significant cognitive improvement was observed in a smaller patient group. Athira has completed enrollment for a Phase II/III trial for mild-to-moderate Alzheimer's, with results expected later this year.

Alzheon’s ALZ-801: Alzheon is developing what could be the first oral treatment to modify Alzheimer's disease by preventing the formation of toxic amyloid oligomers. ALZ-801 is being tested in patients with the APOE4 gene variant, who are more prone to amyloid-beta accumulation. The drug has shown promise in preserving the hippocampus without increasing the risk of ARIA in a Phase II trial. Phase III results are expected mid-year.

Prothena’s PRX012: With the FDA's Fast Track designation, PRX012 is a next-generation anti-amyloid antibody delivered subcutaneously. Despite being in Phase I, the drug has garnered investor interest due to its convenient administration and potential to avoid ARIA. However, clinical readouts have been delayed.

Axsome Therapeutics AXS-05: This candidate is a symptomatic treatment for Alzheimer's disease-related agitation, a condition affecting approximately 70% of Alzheimer's patients. Axsome is repurposing an existing antidepressant for this purpose. The company's second pivotal Phase III study is expected to report results in the second quarter of 2024.

As of January 2023, there were numerous trials underway for Alzheimer's disease, with many more expected to report in 2024, offering hope for new treatment options. Suvannavejh expressed enthusiasm for the innovation in this field.