A Pill for Alzheimer’s Treatments?
Although new Alzheimer’s drug Leqembi is FDA-approved as a potentially disease-modifying treatment, it remains challenging for many patients to access. Compared to taking pills like Advil or Tylenol, getting a dose of this new Alzheimer’s infusion can be expensive, not to mention time-consuming. Many Americans might find themselves driving more than two hours round trip for treatment.
Drugmakers have taken notice of the access problem associated with infusion-based Alzheimer’s treatments. Now, there are a number of clinical trials underway, testing Alzheimer’s treatments in pill form.
The chemistry behind these experimental new Alzheimer’s drugs makes them easier and cheaper to manufacture than antibody drugs like Leqembi. And, since pills can be taken safely at home, patients don’t need to travel to a specialist to receive the treatment.
Here’s what you need to know about the Alzheimer’s pills currently in phase 3 clinical trials.
Alzheon: valiltramiprosate
From drugmaker Alzheon, Alzheimer’s pill valiltramiprosate is designed to prevent healthy forms of beta-amyloid from clumping up into toxic plaques in the brain. In phase 2 trials, the data showed the drug appeared to lower levels of Alzheimer’s biomarkers in the blood and reduced brain shrinkage.
In the ongoing phase 3 study, Alzheon is testing whether the drug can slow the progression of Alzheimer’s disease in 300 people with early-stage Alzheimer’s who have two copies of the APOE4 gene. This gene increases the chances of developing Alzheimer’s and speeds up its progression—and some scientists even contend that carrying two copies of APOE4 all but guarantees a genetic form of Alzheimer’s.
The company announced in an April press release that it expects to receive preliminary data from the trial and submit an application for drug approval by the end of the year.
Annovis Bio: buntanetap
In Alzheimer’s disease, protein plaques and deposits build up in the brain. These proteins are linked to inflammation, brain cell death, and cognitive decline. Annovis Bio’s experimental pill-based Alzheimer’s treatment, buntanetap, is designed to prevent the formation of multiple types of these toxic proteins.
Annovis Bio recently released results from buntanetap’s phase 2/3 clinical trial, which tested the drug in 353 patients diagnosed with mild to moderate Alzheimer’s. At the end of the study, the participants who received the drug showed no difference from the placebo group in terms of rate of cognitive decline. However, a subset of participants who were in the earlier stages of Alzheimer’s—with biomarkers of the disease in their blood—may have benefited. The company plans to conduct an additional Phase 3 trial of buntanetap to confirm these benefits.
AriBio: AR1001
AR1001 works similarly to Viagra, which is linked in multiple studies with a reduced Alzheimer’s risk. In fact, the two drugs have so much overlap, AR1001 is approved for erectile dysfunction in South Korea. The drugmaker is currently running a year-long phase 3 trial of 1,150 early-stage Alzheimer’s patients.
Cassava Sciences: simufilam
Simufilam is a small molecule drug that helps a certain protein, filamin A (FLNA)function properly. When FLNA isn’t working correctly, it might cause beta-amyloid build-up and inflammation in the brain.
Cassava announced positive results from participants in an open-label extension of its clinical trial. Despite skepticism from many Alzheimer’s researchers, the company expects to see results from the first two Phase 3 clinical trials of 1,929 patients with early Alzheimer’s by the end of next year.