Full Press Release Details
Bio Presented at the 14th Clinical Trials on Alzheimer's Disease Conference
additional data, the primary, secondary, and exploratory endpoints were met in Phase 2a study
PA., November 12, 2021 -- Annovis Bio, Inc. (NYSE American: ANVS) ("Annovis" or the "Company"), a clinical-stage
drug platform company addressing Alzheimer's disease (AD), Parkinson's disease (PD), and other neurodegenerative diseases, today reported
new data on ANVS401 from the Company's Phase 2a study during the 14th Clinical Trials on Alzheimer's Disease conference (CTAD).
is an oral translational inhibitor of neurotoxic aggregating proteins (TINAPs) currently being developed for AD, AD in Down Syndrome,
and PD. In the Phase 2a trial, ANVS401 was shown to be well-tolerated and safe, and its pharmacokinetics was found to be in line with
levels measured earlier in humans, meeting both the primary and secondary endpoints. Additionally, exploratory endpoints were met when
the Phase 2a data showed that ANVS401 treatment resulted in statistically significant improvement in motor function in PD patients and
cognition in AD patients.
from the Phase 2a clinical trial presented today at CTAD showed that treatment with ANVS401 reduced neurotoxic proteins in both AD and
PD patients (Figure 1). Further, ANVS401 decreased inflammation and improved axonal integrity and synaptic functions in both AD and PD
patients (Figure 2 and Figure 3). All values are in comparison to placebo and are based on all data points.
1 - APP (and its downstream products), t-Tau, and p-Tau are the neurotoxic proteins involved in AD, while -Synuclein ( -Syn)
is the neurotoxic culprit of PD.
2 - Inflammatory markers are lowered in both AD and PD patients, showing a stabilization of inflammation in both neurodegenerative disorders.
3 - Neuronal and synaptic markers are lowered in both AD and PD patients, meaning that the nerve cells are healthier.
data strengthens the understanding of optimal ANVS401-induced neurotoxic protein reduction in both animal models and humans. In the Phase
2a study, most biomarkers and inflammatory markers of both AD and PD treated patients were reduced by 3 to 20% at ANVS401 doses that
saw significant improvement in cognition and function. This aligns with AD and PD mouse model studies that showed APP and -Syn
were reduced by 5 to 20% and 3 to 10%, respectively, at ANVS401 doses that also saw significant improvement in cognition and function.
This suggests that slight changes in ANVS401-reduced neurotoxic proteins result in significant downstream effects in both animals and
believe we have begun to unravel the relationship between biomarker reduction and efficacy, a topic that has been a focus of research
for some time. By comparing biomarker levels at fully effective doses of ANVS401 in both mice and humans suffering from AD and PD, we
see that a small reduction in biomarkers and inflammatory markers is sufficient to lead to statistically significant improvements in
outcomes," commented Founder, President and CEO of Annovis Maria Maccecchini, Ph.D. "Meeting primary endpoints and the reversal
of the toxic cascade combined with improvements in cognition and function are the foundation for us to ask the FDA for two meetings -
one to move into two phase 3 clinical trials for AD and one to move into two phase 3 clinical trials for PD."
primary endpoint of the Phase 2a clinical trials, safety, was met as no serious adverse events (AEs) and no AEs leading to dosage withdrawal
were observed in both Phase 2a clinical trials. It should be noted that most AEs were due to spinal fluid collection, which typically
results in headaches and back aches in patients. Another endpoint was pharmacokinetics and the plasma levels of ANVS401 measured in this
study corresponded to plasma levels seen in previous human studies.
replay of the presentation will be available on demand on the conference website after 48 hours. The presentation slides will be also
available on the Investors & Media tab of the Annovis website.
in Berwyn, Pennsylvania, Annovis Bio, Inc. (Annovis) is a clinical-stage, drug platform company addressing neurodegeneration, such as
Alzheimer's disease (AD), Parkinson's disease (PD), and Alzheimer's in Down Syndrome (AD-DS). We believe that we are the only company
developing a drug for AD, PD, and AD-DS that inhibits more than one neurotoxic protein and, thereby, improves the information highway
of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. We conducted
two Phase 2 studies: one in AD patients and one in both AD and PD patients. In the AD/ PD study our drug improves memory loss and dementia
associated with AD, as well as body and brain function in PD.
in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking
statements contained in this press release may be identified by the use of words such as "anticipate," "expect,"
"believe," "will," "may," "should," "estimate," "project," "outlook,"
"forecast" or other similar words, and include, without limitation, statements regarding the timing, effectiveness, and anticipated
results of ANVS401 clinical trials. Forward-looking statements are based on Annovis Bio, Inc.'s current expectations and are subject
to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based
on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully
in the section titled "Risk Factors" in the Annual Report on Form 10-K for the year ended December 31, 2020, filed with the
Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Annovis Bio,
Inc. undertakes no duty to update such information except as required under applicable law.
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