Cassava Science Announces Positive Results in Phase 2 Trial for New Alzheimer’s Disease

Losing a loved one with Alzheimer’s disease is a horrifying and painful process, and many Americans are familiar with it all. Still, little is known about how to treat and prevent this degenerative condition, despite the fact that more than 5 million Americans live with Alzheimer’s disease.

On Monday, September 14, biotechnology company Cassava Science announced that its Alzheimer’s disease treatment, Sumiphyllum, had positive results in the treatment of patients with Alzheimer’s disease in a phase II trial. The data will be presented at HC Wayne Light’s 22nd Global Investment Conference.

“I feel this is a drug that ultimately provides some real hope for patients with Alzheimer’s disease as well as those with a family history of Alzheimer’s disease,” said Remi, founder and CEO of Cassava Science. Barbier said. “Until now, these patients had little hope.”

< position="inread" progressive="" ad-id="article-0-inread" aria-hidden="true" role="presentation"/>

In a cassava phase II trial, of the 64 patients, those treated with Sumiphyllum showed improvements in biomarkers and cognitive tests that showed multiple diseases compared to patients treated with placebo. Patients treated with 100 mg of Sumiphyllum had an 18% reduction in total tau levels and a 14% increase in amyloid beta 42 (in Alzheimer’s disease, high tau levels and low amyloid beta 42). Although these results were not statistically significant, patients treated with Sumiphyllum also showed improved memory tests.

Alzheimer’s disease is a neurological disorder that causes progressive cell death in the brain, leading to confusion and memory loss. It can affect people of all ages, but it is most common in the elderly, and 1 in 10 people over 65 I have Alzheimer’s disease. The disease can overwhelm the female, black, and Hispanic communities and ultimately be fatal. Even though it is the sixth leading cause of death in the United States, it remains a mystery why some people get the disease and whether it can be cured.

We know two proteins found in the brain, Beta amyloid and tau, Has been found at abnormal levels in the brains of people with Alzheimer’s disease. Both proteins are toxic, forming clumps and tangles and disrupting cell function in the brain. Most of the Alzheimer’s disease drugs approved and studied today target beta-amyloid or tau and seek to purify the accumulation of these toxic proteins from the brain. However, this is not the root cause of the disease, as we still do not know why and how these proteins are unknown to some, not to others. “Not all approved drugs actually cure the underlying disease,” says Adam Boxer, a researcher at Alzheimer’s and head of the UCSF Neuroscience Clinical Research Unit. The boxer was not involved in the study of cassava.

Sumiphyllum works by targeting filamin A, a protein that, when altered, can affect the toxic proteins that cause Alzheimer’s disease. “Amyloid destroys protein tau, which requires the complicating protein filamin A,” said Lindsay Burns, principal investigator of Cassava’s Alzheimer’s disease program. She says that when Filamin A is restored to its normal form, amyloid does not confuse Tau.

With a focus on Filamin A, cassava’s approach is clearly different from most other life sciences companies. “I think the most developed drugs and treatment programs are still focused on amyloid and tau proteins,” says Boxer. Biogen, one of the leaders in the competition for the new Alzheimer’s drug, has received FDA priority review for its drug aducanumab last monthIt targets amyloid proteins and may be approved as early as the first quarter of 2021.

Austin-based cassava science was founded in 1998 and has not yet brought medicines to market. With a market capitalization of $ 83 million, Sumiphyllum is currently the only candidate drug. So there is a lot of pressure on the success of this drug. In May 2020, the company faced a hurdle when an independent laboratory analyzing Cassava data reported a Phase 2 study funded by the National Institutes of Health. Does not meet the primary endpoint.. “Our heart has sunk,” says CEO Barbier. But if you take a closer look at the data, “there were some very quirky data,” he said. Biomarkers that should rise and fall together moved separately, and patients in the placebo group of the study showed significantly different results. The company sent the data to a second independent lab for analysis, but the first analysis found inconsistencies and the Phase 2 trial reported positive results.

The trial is still limited. First, the drug was tested in only 64 patients over a 28-day period. Alzheimer’s disease can progress very slowly, and it can take months or years to notice the difference in symptoms. This is the next step in cassava science. This is a large-scale Phase 3 study that will take several years. Cassava plans to begin Phase 3 trials by the end of 2021, according to Barbie.

In addition to Sumiphyllum, Cassava Science is also working on the development of diagnostic tests for Alzheimer’s disease. The goal is to draw blood to identify who is at risk for Alzheimer’s disease or who is in the early stages of developing the disease before the onset of symptoms. This allows people to start treatment early and hopefully delay or even reverse the illness.

Cassava Science is not the only company working on new drugs and trials for Alzheimer’s disease. But based on their latest results, Barbier says.