On May 19th, Annovis Bio (ANVS) a clinical staged drug platform dealing with Alzheimer Disease, Parkinsons’s Disease and other neurodegenerative diseases announced results from it’s double blind, placebo-controlled trial for its lead drug ANVS401 for the treatment of Alzheimer and Parkinsons Diseases.
Currently the stock is up +115%.
The results successfully shows that levels of inflammatory markers in Parkinson’s Disease patients are significantly lower than before taking treatment.
“These positive results confirm ANVS401’s potential to be a meaningful treatment for neurodegeneration. Our study reveals a highly statistically significant lowering of inflammatory markers in Parkinson’s disease patients, which is one step in reversing the toxic cascade. Today’s news combined with our previous study results revealing ANVS401 increases speed, coordination and motor function in PD patients mark important milestones, as we continue to pursue a novel approach and therapy to fight Parkinson’s and Alzheimer’s diseases.”
“Our hypothesis is that nerve cells die because high levels of neurotoxic proteins impair axonal transport, increase inflammation and eventually lead to nerve cell death and permanent loss of function. When we administer our drug, we expect a reversal of this toxic cascade leading to efficacy. Inflammation is a very important step in the toxic cascade, because it lasts for years and takes over the entire brain. Therefore, reversing inflammation means that we have reversed at least one step of the toxic cascade leading to nerve cell death.”
Annovis Bio CEO – Dr Maria Maccecchini, PhD
The trial measured 4 inflammatory markers that are in the brains of Alzheimer and Parkinson’s Disease patients. The results showed significant reduction in these inflammatory markers after 25 days of treatment with ANVS401.
| Inflammatory Marker | % Change from Baseline p-Value |
| Complement C3 | -24.9 | 0.0072 |
| YKL40 | -22.9 | 0.0213 |
| sTREM2 | -28.2 | 0.0108 |
| GFAp | -34.6 | 0.000001 |
“The inflammatory marker data presented here substantiates and confirms the efficacy of ANVS401 in PD patients we reported in March.”
Annovis Bio CEO – Dr Maria Maccecchini, PhD
Annovis Bio’s Next Steps
The cerebral spinal fluid and plasma samples of patients who completed treatment are currently being analyzed to measure the reversal of the toxic cascade. The data is expected to be reported in the next 2 months and the full study data and analysis of the 40 Parkinson Disease patients is expected to be released in July or August of this year.
Following completion of the Phase 2a trial Annovis Bio will request a meeting with the FDA to present the data and results of the trial and it’s chronic toxicology study in animals. The company believes that its data and prior clinical results support the potential of the advancement of ANVS401 into late stage studies which is targeted in late 2023, assuming successful Phase2a study.
