Annovis Bio Announces Positive Interim Independent Analysis for Statistical Power in Its Alzheimer’s Study
Annovis Bio, Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a
clinical-stage drug platform company addressing neurodegenerative
diseases, today announced that the independent statistical group
concluded that its Phase 2/3 AD study was sufficiently powered to
continue as originally planned without the addition of patients.
This phase 2/3 AD study is designed to enroll a total of 320 mild
to moderate AD patients, who are randomly assigned to receive 7.5,
15, 30 mg of buntanetap or placebo once per day. The trial’s
co-primary endpoints are the change from baseline to the end of
treatment of Alzheimer’s Disease Assessment Scale-Cognitive
Subscale 11 (ADAS-Cog11) and Alzheimer’s Disease Cooperative Study
Clinician’s Global Impression of Change (ADCS-CGIC), which assess
cognition and activities of daily living.
The Company has received the results of the pre-planned interim
analysis conducted by an independent data analytics provider. The
interim analysis was based on 107 patients at 6 weeks from all
cohorts collectively and showed that the AD trial should continue
as planned with the same trial size to maintain the statistical
power for both co-primary endpoints.
The Company remains blinded to the Phase 3 trial and does not
have safety or efficacy data from the trial. A separate safety
interim analysis is in process and we expect that interim analysis
to be released in two weeks.
Maria L. Maccecchini, Ph.D., Founder, President, and CEO of
Annovis, commented: “Although we remain blinded to the data,
results from this interim analysis supports our original
statistical powering for enrolling 320 patients into the Phase 2/3
Alzheimer’s study. Therefore, sample size re-estimation for the
study is not necessary, which in our view, may signal an emerging
positive treatment effect in patients receiving buntanetap versus
those receiving placebo after just 6 weeks of treatment. While the
interim analysis does not mean that the trial will necessarily be
successful, it does mean that the trial is powered for potential
Update and projections of our ongoing activities:
- to date, 230 patients have been enrolled and 62 have finished
- safety interim analysis, conducted by the DSMB on October 18,
will be released the week of October 23;
- full enrollment anticipated in November;
- completion of treatment expected in February 2024;
- phase 2/3 data expected in March 2024.
- to date, 305 patients have finished the study;
- completion of study expected by the end of November;
- phase 3 data expected in January 2024.
In addition to the ongoing clinical studies, we are also excited
about the novel crystal form of buntanetap - ANVS402. We expect to
discuss with the FDA the transition buntanetap to ANVS402 and the
development of the new form. The bridge studies are expected to be
completed in Q1 2024.
As we move forward with our advanced, clinical-stage AD and PD
programs, we hope to demonstrate buntanetap’s unique ability to
inhibit the accumulation of pro-inflammatory, neurotoxic proteins
and potential to address unmet medical need across a number of
neurodegenerative conditions and diseases.
About BuntanetapBuntanetap (previously known as
ANVS401 or Posiphen) is an investigational, oral translational
inhibitor of neurotoxic aggregating proteins (TINAPs), which mode
of action is thought to lead to a lower level of neurotoxic
proteins and consequently less toxicity in the brain. In a Phase 2a
clinical trial in AD and PD patients, buntanetap was shown to be
generally well-tolerated, and its pharmacokinetics were found to be
in line with levels measured earlier in humans, meeting both the
primary and secondary endpoints. Additionally, exploratory
endpoints were also met, as treatment with buntanetap resulted in
statistically significant improvement in motor function in PD
patients and cognition in AD patients. Presently buntanetap is
being studied in a Phase 3 early PD study and in a Phase 2/3 study
in AD patients.
About Annovis Bio, Inc.Headquartered
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 other chronic neurodegenerative diseases. We
believe that we are the only company developing a drug for AD and
PD 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. Annovis conducted two Phase 2 studies: one in
AD patients and one in both AD and PD patients. In the AD/PD study
buntanetap showed improvements in cognition and memory in AD as
well as body and brain function in PD patients.
For more information on Annovis Bio, please visit the
Company's website www.annovisbio.com and follow us
on LinkedIn and Twitter.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements relate to all information other than
historical matters, such as expectations or forecasts of future
events. Forward-looking statements may be identified by the use of
words such as "forecast," "intend," "seek," "target," "anticipate,"
"believe," "expect," "estimate," "plan," "outlook," and "project"
and other similar expressions that predict or indicate future
events or trends or that are not statements of historical matters.
Forward-looking statements with respect to the operations,
strategies, prospects and other aspects of the business
of Annovis Bio are based on current expectations that are
subject to known and unknown risks and uncertainties, which could
cause actual results or outcomes to differ materially from
expectations expressed or implied by such forward-looking
statements. These risks and uncertainties include but are not
limited to delays in clinical trials and in reporting of the data.
These and other risks and uncertainties are described more fully in
the section titled "Risk Factors" in Annovis Bio's Annual
Report on Form 10-K for the year ended December 31, 2022, and
other periodic reports filed with the Securities and Exchange
Commission. You are cautioned not to place undue reliance upon any
forward-looking statements, which speak only as of the date made.
Although it may voluntarily do so, from time to time, Annovis
Bio undertakes no commitment to update or revise the
forward-looking statements contained in this presentation, whether
as a result of new information, future events or otherwise, except
as required under applicable law.
Media Contact:Maria Maccecchini,
Annovis Bio (AMEX:ANVS)
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