FDA indicates the Company may proceed with the Phase 3
clinical study of buntanetap for the treatment of Parkinson's
disease
BERWYN,
Pa., July 7, 2022 /PRNewswire/ -- Annovis Bio,
Inc. (NYSE: ANVS) ("Annovis" or the "Company"), a late-stage
clinical drug platform company addressing neurodegenerative
diseases, announced today that the Company received notice from the
FDA that the Phase 3 clinical study in early Parkinson's patients
may proceed. The FDA accepted the final protocol and the clinical
development plan, approved the use of the Company's new large-scale
batch of good manufacturing practice material, and found the
chronic toxicology in rats and dogs safe and adequate to support
long-term human studies lasting decades compared to the previous
restriction of one month.
Following a successful Type B meeting for the continued
development of buntanetap in Parkinson's disease with the FDA
earlier this year, the Company requested consideration from the FDA
on amending the accepted development plan, finalizing the protocol
for the Phase 3 study, and proceeding with longer duration clinical
trials. The Company submitted all the safety data in mice, rats,
dogs and over 200 humans, the chemistry, manufacturing, and
controls package for the new large-scale batch, and all the data
accumulated over the years for the Company's Alzheimer's disease
program that also pertained to Parkinson's disease program.
PROTOCOL
TITLE
|
A 6-month
prospective, randomized, double-blind, placebo-controlled
clinical trial investigating the efficacy, safety, and tolerability
of two
different doses of buntanetap or placebo in patients with early
Parkinson's disease
|
STUDY
DESIGN
|
Placebo-controlled and
double-blind in 100 sites in the US and EU
|
INVESTIGATIONAL
PRODUCT
|
Buntanetap 10 mg, 20
mg, or placebo capsules, taken orally once a day for 6
months
|
SUMMARY OF KEY
ELIGIBILITY CRITERIA
|
Diagnosis of idiopathic
PD, Age 40 to 85, MMSE 22-30,
Hoehn & Yahr = 1,2,3 and OFF-state < 2hrs per day
|
PRIMARY OUTCOME
MEASURES
|
MDS-UPDRS Part
II+III
|
SECONDARY OUTCOME
MEASURES
|
• Total
MDS-UPDRS score
•
Participant Global Impression of Change (PGIC)
•
Clinical Global Impression of Severity of illness
(CGIS)
|
"We are pleased that the FDA has approved our clinical trial
design in early PD patients and called it a well-designed study.
The positive FDA review affirms the Company's path to securing
approval for buntanetap to treat neurodegenerative diseases,
including Parkinson's and Alzheimer's diseases, with longer
treatment regimens," said Maria L. Maccecchini, Ph.D., Founder,
President, and CEO of Annovis Bio. "With this FDA notice in hand,
we are thrilled to start recruiting for the US clinical trial soon,
expected later this summer."
About Buntanetap
Buntanetap (previously known as ANVS401 or Posiphen) is an oral
translational inhibitor of neurotoxic aggregating proteins
(TINAPs), which mode of action leads to lower levels of neurotoxic
proteins and consequently less toxicity in the brain. In a Phase 2a
clinical trial in AD and PD patients, treatment with buntanetap
resulted in statistically significant improvement in motor function
in PD patients and cognition in AD patients. Additionally, the drug
was well-tolerated and safe, and its pharmacokinetics were found to
be in line with levels measured earlier in humans, meeting both the
primary and secondary endpoints.
About Annovis Bio, Inc.
Headquartered in Berwyn,
Pennsylvania, Annovis Bio, Inc. is a late-stage clinical
drug platform company developing transformative therapies that
treat neurodegenerative disorders such as Alzheimer's disease (AD),
Parkinson's disease (PD) and other chronic and acute
neurodegenerative diseases. The Company believes that it is the
only company developing a drug that inhibits more than one
neurotoxic protein, improves the information highway of the nerve
cell, known as axonal transport, reduces inflammation and protects
nerve cells from dying in chronic and acute neurodegeneration.
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
Statements
Statements 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 buntanetap 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, 2021, 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.
Media and Investor Contact:
Nic Johnson
Russo Partners, LLC
(303) 482-6405
nic.johnson@russopartnersllc.com
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SOURCE Annovis Bio