Full Press Release Details
Frequently Asked Questions
Annovis Bio Phase 2a Data Results
Answer: On July 28, we announced
interim results among both Alzheimer's disease (AD) and Parkinson's disease (PD) patients from Phase 2a clinical trials of
our lead compound, ANVS401 (Posiphen).
The results were positive - over the
first 25 days of treatment, the initial patient cohorts demonstrated statistically significant positive results in both cognitive and
motor skills. The biomarkers presented and analyzed also corroborated the efficacy of ANVS401.
We are aware that some initial reporting after our presentation at
the AAIC 2021 conference included an error in which the scores of the WAIS test were transposed between placebo and treated PD patients.
We have received a number of questions regarding this error and believe it led some people to conclude that the placebo was more effective
than treatment with ANVS401, which is incorrect.
Answer: Statistical significance separates random events from
events that are caused by a specific intervention. The FDA looks at a drug as being effective if the efficacy measured has a less than
5% chance (p<0.05) of being due to the random daily behavior of patients. If the effect observed has a greater than 5% chance (p>0.05)
of being due to random behavior, then it is called non statistically significant and it means that the drug did not affect treated patients.
In the case of ANVS401 we saw statistically significant changes (p<0.05)
in ADAS-Cog11, MDS-UPDRS and WAIS, showing efficacy of the drug in AD and PD patents.
We also showed non statistically significant data in the mini mental
state examination (MMSE) and clinical dementia rating sum of boxes (CDR), reflecting that the scores were due to random changes in behavior.
Answer: The WAIS coding scale measures visual-motor dexterity,
associative nonverbal learning, and nonverbal short-term memory. It measures fine-motor dexterity, speed, accuracy, and ability to manipulate
a pencil and perceptual organization.
Answer: After 25 days of treating PD patients with 80 mg a day
of ANVS401, the speed and accuracy of the patients is faster than at baseline (6.1 points, p<0.05) and faster than the placebo treated
group (9.8 points, p<0.05). Both scores are statistically significantly better in the treated group, whether compared to baseline or
Answer: After 25 days of treating AD patients with 80 mg a day
of ANVS401, the speed of the treated group is faster than at baseline, and the patients on average coded 6.6 more correct fields. The
improvement in treated AD patients compared to baseline was statistically significant. At 25 days, the placebo group improved slightly,
but not as much as the ANVS401 treated group.
Answer: Yes, the outcome of the WAIS coding test is statistically
significant and confirms the statistical significance of the ADAS-Cog11 and MDS-UPDRS tests in both AD and PD patients.
Answer: This study was planned with the primary endpoints being
biomarkers. The fact that we saw cognitive and functional improvement is an additional benefit.
We saw statistically significant improvements in the ADAS-Cog11, MDS-UPDRS,
and in the WAIS tests and not statistically significant results in the MMSE and CDR.
While we conducted all of these tests to look at a full cognition panel,
we did not necessarily expect the MMSE and CDR to change, because while the ADAS-Cog11 and MDS-UPDRS are nimble tests that can show a
change in a short period of time, the MMSE and CDR are less sensitive and generally would not be expected to change in one month.
Answer: No, the changes in patients in the MMSE and CDR tests
were not statistically significant, which is interpreted to mean that the difference is due to randomness and not to the effect of the
drug, whereas statistical significance means that the change is due to the effect of the drug.
Answer: The cytotoxic cascade data is important because chronic
brain insults lead to high levels of neurotoxic proteins, that cause impairment in the axonal transport, inflammation, and nerve cell
death, and ultimately impair a patient's cognition and/or movement.
Answer: Yes, the Phase 2a data revealed ANVS401 lowered levels
of neurotoxic proteins for both AD and PD patients and improved cognition and motor function. The data also revealed significant reductions
of neurotoxic proteins levels and inflammation, as well as biomarkers for axonal damage, and highlighted the efficacy data. Our data reveals
ANVS401 improves axonal transport in vitro and in vivo, and by doing so restores normal brain function.
Answer: ANVS401 showed that it improved cognition in Alzheimer's
disease, as measured by ADAS-Cog11 and WAIS assessment scales. ANVS401 improved movement in Parkinson's disease patients as measured
by MDS-UPDRS and WAIS. The efficacy data is corroborated by the biomarkers of the toxic cascade that all point in the direction of an
improvement in AD and PD.
This is the first double-blind placebo-controlled study ever conducted
of which we are aware that shows cognitive improvement in AD and functional improvement in PD patients by the same therapy.
Cautionary Statement Regarding Forward-Looking Information
The foregoing frequently asked questions contain "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than those of historical
fact in the frequently asked questions documents are forward-looking statements. Forward-looking statements may be identified by terminology
such as "believe," "anticipate," "plan," "may," "intend," "will,"
"should," "expect," "estimate," "potential" and "continue" and similar expressions,
including the negative of these words, but not all forward-looking statements contain these words. Forward-looking statements include,
but are not limited to, statements regarding Annovis Bio's expectations and timelines regarding Annovis Bio's Phase 2a clinical
trial and expectations regarding current or future clinical trials. Forward-looking statements are based on Annovis Bio'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. Actual results could differ materially from
those described or implied by such forward-looking statements as a result of various important factors, including, without limitation,
the failure of preliminary data to predict final study results and impacts from the COVID-19 pandemic and the other important factors
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 ("SEC") and elsewhere in our filings
and reports with the SEC. Forward-looking statements speak as of the date they are made, and Annovis Bio undertakes no obligation to update
them except as may be required under applicable law.