ProgN said:
techno-ag said:
confucius_ag said:
ProgN said:
No Decline in Cognition Scores in Patients with Mild Alzheimer's Disease Who Received Simufilam Continuously For 24 Months | Cassava Sciences, Inc.
Quote:
AUSTIN, Texas, Feb. 07, 2024 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (Nasdaq: SAVA), a biotechnology company, today reported top-line results of a two-year clinical safety study of simufilam, an investigational oral drug for the proposed treatment of Alzheimer's disease dementia. The study enrolled over 200 patients with mild to moderate Alzheimer's and consisted of two open-label treatment phases and a randomized, placebo-controlled withdrawal phase. Average changes in ADAS-Cog scores, baseline to month 24, indicate the following:
Patients with mild Alzheimer's disease who received simufilam treatment continuously for two years (n=47) had no decline in ADAS-Cog scores ( 1.51 SE) as a group.
Patients with mild Alzheimer's who received simufilam treatment non-continuously (n=40) declined 1 point on ADAS-Cog ( 1.65 SE) as a group. Non-continuous treatment consisted of one year on open-
label drug, six months on placebo and six months back on open-label drug.
In patients with mild Alzheimer's, the largest separation between the continuous and non-continuous treatment groups occurred at the end of the 6-month randomized, placebo-controlled withdrawal phase.
Patients with moderate Alzheimer's who received simufilam treatment continuously for two years (n=32) declined 11.05 points on ADAS-Cog ( 1.91 SE) as a group.
"We're fighting Alzheimer's disease by testing simufilam, a new type of drug that has a completely different mechanism of action from monoclonal antibody drug treatments," said Remi Barbier, President & CEO. "Stable ADAS-Cog scores over 2 years is clearly a desirable clinical outcome in Alzheimer's. Our data in mild patients may emphasize the importance of treating patients early in the disease."
Is 200 patients large enough of a sample size to be significant?
Beware. Lots of questions about that research. Read at the link if interested in learning more. I'll give summary paragraphs:
https://www.science.org/content/article/potential-fabrication-research-images-threatens-key-theory-alzheimers-disease
Quote:
In August 2021, Matthew Schrag, a neuroscientist and physician at Vanderbilt University, got a call that would plunge him into a maelstrom of possible scientific misconduct. A colleague wanted to connect him with an attorney investigating an experimental drug for Alzheimer's disease called Simufilam. The drug's developer, Cassava Sciences, claimed it improved cognition, partly by repairing a protein that can block sticky brain deposits of the protein amyloid beta (A), a hallmark of Alzheimer's. The attorney's clientstwo prominent neuroscientists who are also short sellers who profit if the company's stock fallsbelieved some research related to Simufilam may have been "fraudulent," according to a petition later filed on their behalf with the U.S. Food and Drug Administration (FDA).
Schrag, 37, a softspoken, nonchalantly rumpled junior professor, had already gained some notoriety by publicly criticizing the controversial FDA approval of the anti-A drug Aduhelm. His own research also contradicted some of Cassava's claims. He feared volunteers in ongoing Simufilam trials faced risks of side effects with no chance of benefit.
So he applied his technical and medical knowledge to interrogate published images about the drug and its underlying science-for which the attorney paid him $18,000. He identified apparently altered or duplicated images in dozens of journal articles. The attorney reported many of the discoveries in the FDA petition, and Schrag sent all of them to the National Institutes of Health (NIH), which had invested tens of millions of dollars in the work. (Cassava denies any misconduct [see sidebar, below].)
That came out years ago and investigate by the FDA. The FDA didn't find any reason to shutdown SAVA and allowed them to proceed with phase III human trials. It had all signs of attack financed by a big short seller and/or competitor developing their own Alz treatment.
It's not just the Cassava research that's in question, it's the original experiments pointing to a theory of causation for Alzheimer's that have shown to be very problematic. This has resulted in a couple decades of research chasing down (possibly) the wrong treatments.
Anyway, due diligence yada yada.