Berwyn, Pennsylvania, May 21, 2021 (Newsfile Corp via COMTEX) -- Berwyn, Pennsylvania--(Newsfile Corp. - May 21, 2021) - Annovis Bio Inc. /zigman2/quotes/216213707/composite ANVS +11.10% , a clinical-stage drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD) and other neurodegenerative diseases, today announced new results from a double-blind, placebo-controlled study of ANVS401, its lead drug candidate for the treatment of AD and PD. Patients treated with ANVS401 for 25 days showed statistically significant cognitive improvement as measured by the Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog11). The 11-part test is one of the most frequently used tests to measure impaired cognition in clinical trials for AD.
Dr. Maria L. Maccecchini, CEO of Annovis Bio, explained: "We previously reported that ANVS401 significantly increased speed, coordination and motor function in PD patients in this trial. We set up this study to measure the toxic cascade leading to nerve cell death and loss of function and its reversal in AD and PD. Since the study was powered to investigate changes in biomarker levels, not to demonstrate efficacy, we believe these results are that much more impactful."
From baseline to 25 days in the ANVS401-treated group, ADAS-Cog11 improved by 4.4 points, a statistically significant improvement of 30% (p=0.04).
Additionally, the ANVS401-treated group compared to placebo group at 25 days showed an improvement of 3.3 points, or 22% (p= 0.13).
This is the first double-blind, placebo-controlled study that shows cognitive improvements in AD patients as measured by ADAS-Cog and functional improvements in PD patients as measured by the Unified Parkinson's Disease Rating Scale (UPDRS).
"The results from the first cohort of 14 AD and 14 PD patients, show that the drug is effective in both diseases," stated Dr. Maccecchini. "Seeing efficacy in both patient populations supports our hypothesis that the impairment of axonal transport, the information highway of the nerve cell, affects nerve cells in the same way in both diseases. The toxic cascade in neurodegeneration begins with high levels of neurotoxic proteins, which impair axonal transport, increase inflammation and eventually lead to nerve cell death and permanent loss of cognition and function."
High levels of neurotoxic proteins lead to impaired axonal transport, which is responsible for the communication between and within nerve cells. By inhibiting the translation of multiple neurotoxic proteins, ANVS401 improves axonal transport, reduces inflammation, protects nerve cells from dying and leads to better cognition and function.
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On the left (Figure 1) there are three pictures of axonal transport through an axon (arm) of a nerve cell. The first picture shows the axon of a normal healthy nerve cells: the black dots depict information packages which flow smoothly from the left to the right. In the middle is the arm of a sick nerve cell. The information packages stop, then move, then stop again. At the bottom, the same sick nerve cell is treated with ANVS401 and the information flow is re-established. This shows in a very visual way, how normalizing axonal transport increases the flow and re-establishes normal function.
Comparison to Other Studies
In 2019, Biogen reported the data from its EMERGE study, a double-blind, placebo-controlled large phase 3 study and showed an improvement of 1.4-points in ADAS-Cog13 over one year.
In February 2021, Cassava reported in an open-label phase 2 study a 1.6-point improvement in ADAS-Cog11 over six months.
With ANVS401 in a double-blind, placebo-controlled study, Annovis Bio is reporting statistically significant improvements in ADAS-Cog11; specifically, a 4.4-point improvement, when the same people are measured at baseline and 25 days later. We also see a 3.3-point improvement when at 25 days we compare placebo to treated in less than one month. While we do not know how ANVS401 will affect cognition after more than one month of treatment, the present results show promise that the drug may improve or stop the course of AD.