Why the ADDF Is Betting $5M on This Experimental Alzheimer’s Drug

By | July 3rd, 2024

Drugmaker Coya Therapeutics received a $5 million investment for their experimental Alzheimer’s treatment COYA-302, which targets the body’s immune system.

A new anti-amyloid drug for Alzheimer’s disease might receive FDA approval as soon as this month. Although anti-amyloid drugs have shown us that clear amyloid plaques from the brain can slow cognitive decline, experts say they aren’t a silver bullet for Alzheimer’s disease.

In fact, while drugs like Leqembi and its likely soon-to-be-approved follow-up donanemab are “proof of the amyloid hypothesis as a contributing factor to the pathogenesis of Alzheimer’s,” the tangible benefits of these drugs for patients are “rather modest,” according to Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation. Fillit believes other approaches are needed to treat Alzheimer’s. 

The ADDF is hoping to accelerate the development of drugs that target the biology of aging, as it is the greatest risk factor for developing Alzheimer’s. The foundation recently invested $5 million into Coya Therapeutics to accelerate the development of COYA-302, an experimental Alzheimer’s drug currently in Phase 2 trials for Alzheimer’s, frontotemporal dementia, and amyotrophic lateral sclerosis (ALS).

What is COYA-302, and how does it work?

COYA-302 is a biologic consisting of two components. 

The first is low-dose interleukin-2 (IL-2), an immune-signaling protein called a cytokine, which activates T regulatory (Treg) cells to mediate inflammation. The second component is CTLA4-Ig, an antibody that suppresses immune cells that might be hyperactive and damaging the brain. This antibody is currently approved for treating two different forms of arthritis.

“We’ve known since the time [Alois] Alzheimer first described Alzheimer’s disease that there are inflammatory cells surrounding the plaques in the brain,” Fillit said. “ It’s finally being recognized that inflammation plays an important role in the disease process, accelerating the disease and causing neurodegeneration, and so there’s a renewed interest in inflammation as a therapeutic target in Alzheimer’s disease.” 

This treatment hopes to hit the sweet spot of inflammation — activating microglia enough to remove plaques in the brain without causing excess damage and inflammation. The drug is also administered subcutaneously, meaning that it doesn’t require hard-to-access infusions like Leqembi.

A Phase 2 study testing low-dose IL-2 alone in 40 patients with mild to moderate Alzheimer’s disease is currently underway.


Mechanism behind Coya Therapeutics’ experimental Alzheimer’s drug COYA-302.

What’s next for the ADDF?

The ADDF has invested $100 million into a program to accelerate the development of new diagnostics, initially funded by billionaires Leonard Lauder and Bill Gates. So far, the fund has made 65 investments into biotech companies and academic programs worldwide, developing blood tests, retinal tests, and digital tests for diagnosing Alzheimer’s disease. 

The ADDF is also funding various experimental drugs in different phases of research that target inflammation, insulin resistance and sensitivity, metabolism, mitochondrial disorders, vascular problems, epigenetics, and autophagy. 

Fillit was excited by two early-stage companies, Therini Bio and Aprinoia Therapeutics, which have unique approaches to treating Alzheimer’s disease. 

Therini Bio is developing a monoclonal antibody that targets a protein called fibrin, which can cause inflammation near the brain’s blood vessels, preventing the activation of microglia in the brain, which can lead to neurodegeneration. 

Their drug, THN391, is currently in Phase 1 trials and is the first drug tested for Alzheimer’s that directly targets vascular contributors to the disease. Aprinoia Therapeutics is developing drugs in pill form with the potential to break down different types of plaques in the brain —These drugs might soon hit human clinical trials. 

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