October 2, 2024 -- InvestorsHub NewsWire -- via NetworkNewsWire
Editorial Coverage: Alzheimer’s disease (“AD”) has become a
focal point in the pharmaceutical industry as recent drugs such as
Leqembi and Kisunla have received U.S. Food and Drug Administration
(“FDA”) approval. However, while these treatments may slow
cognitive decline in AD patients, they do not actually improve
cognition, a critical target for the millions suffering from the
progressive disease. In addition, GLP-1 (glucagon-like peptide-1)
drugs, which were originally developed to manage type 2 diabetes
and since have seen significant effectiveness in treating obesity,
have also shown potential in the treatment of Alzheimer's. However,
there is no molecule or a combination of molecules that enhance
cognitive functions. Thanks to innovative approaches by companies
such as Annovis Bio Inc. (NYSE:
ANVS) (profile), there is reason to be optimistic
about potential future breakthroughs in the AD space. Annovis has
completed early research with compelling results utilizing its lead
drug, buntanetap, in combination with popular drugs approved for
other indications. Broadly speaking, there is ample reason to be
bullish on new treatments for a variety of significant diseases,
including AD and obesity, as companies such as Eli
Lilly (NYSE: LLY), Pfizer Inc. (NYSE:
PFE), Novo Nordisk
(NYSE: NVO) and AbbVie Inc. (NASDAQ: ABBV) are making
investments and progress on historically hard-to-treat
diseases.
- Annovis is at the forefront, testing buntanetap in pivotal
clinical trials as a therapy for Alzheimer’s and Parkinson’s
diseases (“PD”).
- Company has filed three new patents protecting combinations of
buntanetap with drugs such as Trulicity and Viagra, which work
synergistically to improve cognition.
- Double combinations of buntanetap with Trulicity and Viagra, as
well as a triple combination of all three drugs, are prepared to
enter phase 3 clinical trials.
Buntanetap vs. AD
Annovis Bio
Inc. (NYSE: ANVS) is at the forefront of the movement to
develop new safe and effective drugs for neurodegenerative
diseases, including AD. The company has long pursued the goal to
improve the health of nerve cells and, in the process, improve
cognition in neurodegenerative disorders. The company’s lead drug
candidate, buntanetap, has completed late-stage AD and PD clinical
trials and was shown to be efficacious in both indications.
Earlier this year, Annovis announced promising results from its
phase 2/3 clinical trial of buntanetap as an oral therapy for early
AD. The study involved 353 patients and assessed buntanetap’s
efficacy on top of standard of care medications as well as its
safety. The trial demonstrated dose-dependent cognitive benefits in
each treatment dose compared to placebo in patients with early
Alzheimer’s, with the 30mg dose showing the most improvement, as
measured by the AD Assessment Scale-Cognitive Subscale 11
(“ADAS-Cog 11”).
The data was consistent with previous phase 2 AD/PD (NCT04524351) and DISCOVER (NCT02925650)
studies. Additionally, buntanetap was shown to
reduce plasma biomarkers associated with the disease, including
neurofilament light (“NFL”, axonal biomarker), glial fibrillary
acidic protein (“GFAP”, inflammatory biomarker) and tau. Based on
these findings, Annovis plans to conduct a confirmatory phase 3
trial in biomarker-positive early AD patients, the last step before
filing a New Drug Application (“NDA”) for buntanetap as a
symptomatic treatment.
Most recently, the company took an extra step by combining this
drug with available treatments that treat the cognition issue more
holistically. In particular, Annovis began to explore a combination
of buntanetap with Trulicity(R) (dulaglutide) or Viagra(R)
(sildenafil), or even a combination of all three. Each of these
drugs brings its own set of cognitive benefits. Trulicity, a
glucagon-like peptide-1 (“GLP-1”) agonist, helps restore glucose
metabolism in the brain while Viagra improves cerebral blood flow.
When complemented by buntanetap, which inhibits the production of
neurotoxic proteins in the brain, such as amyloid beta, tau,
alpha-synuclein and TDP-43, and improves the flow of information,
these combinations enhance cognition beyond the levels seen in
healthy mice and have the potential to enhance cognition in
patients.
Buntanetap + Combinations vs. AD
Last month, Annovis released new
preclinical data showing a synergistic effect between
buntanetap and dulaglutide (Trulicity) in a mouse model of AD.
Dulaglutide was selected due to its superior blood-brain barrier
permeability, enhancing its ability to work with buntanetap. While
buntanetap alone restored cognitive function to 100% and
dulaglutide to 80%, the combination of the two compounds improved
cognitive function beyond levels in healthy controls by an
estimated 16%, reinforcing management’s contention that combining
therapies can amplify treatment effects.
This data is the very first evidence of a treatment that not
merely restores cognition back to normal levels but exceeds
them.
“We are excited to see that buntanetap significantly amplifies
the effects of dulaglutide on memory and learning, with a 6- to
10-fold increase in efficacy,” said Annovis Bio founder, president
and CEO Maria Maccecchini, PhD, regarding the study results.
Amping up Nonconventional Approaches
GLP-1 agonists
GLP-1 drugs were originally developed to manage type 2 diabetes
by mimicking a hormone that stimulates insulin release and
regulates blood sugar levels. Drugs such as semaglutide and
liraglutide have been highly successful in helping diabetic
patients control glucose levels, as they improve insulin
sensitivity and slow digestion, reducing blood sugar spikes after
meals. However, during clinical trials, researchers noticed an
additional benefit: significant weight loss. This discovery led to
the approval of
GLP-1 drugs such as Wegovy and others for obesity treatment, as
they help suppress appetite and enhance the body’s ability to burn
fat, offering new hope for millions struggling with weight
management. Further, GLP-1 drugs are showing signs to reduce the
risk of heart disease, kidney disease and stroke.
Recently, GLP-1 drugs have shown early promise in the treatment
of AD. Studies suggest that these medications may protect the brain
from damage related to Alzheimer’s by reducing inflammation,
improving insulin signaling in the brain and enhancing
neuroplasticity. According to phase 2b clinical trial data reported
at the Alzheimer’s
Association International Conference(R) 2024 in Philadelphia in
July, the GLP-1 compound liraglutide (Victoza) was shown to
minimize shrinking in specific parts of the brain responsible for
memory, learning, language and decision-making by nearly 50%
compared to placebo.
PDE5 inhibitors
PDE5 inhibitors represent another promising class of molecules
with potential benefits for AD patients and individuals
experiencing cognitive decline. Known for their potent
anti-hypertensive effects, PDE5 inhibitors are commonly used to
treat conditions such as erectile dysfunction (“ED”), where smooth
muscle relaxation is beneficial. Currently, there are four oral
PDE5 inhibitors available in the United States for the treatment of
ED: sildenafil (Viagra, Pfizer), vardenafil (Levitra[R]/Staxyn[R]/,
Bayer), tadalafil (Cialis[R], Eli Lilly), and avanafil (Stendra[R],
Vivus).
Preclinical
studies suggest that PDE5 inhibitors can enhance synaptic
function and improve cognitive abilities, while real-world patient
data suggest they can reduce the risk of dementia. One notable
example is sildenafil (Viagra), which has shown encouraging results
in improving cerebral blood flow, highlighting its potential
therapeutic value in neurodegenerative diseases like
Alzheimer’s.
A Cleveland
Clinic study has supported sildenafil’s potential as an AD
treatment. In the study, millions of de-identified insurance claims
from two independent patient databases were analyzed, indicating a
30–54% reduced prevalence in AD diagnoses among patients who took
sildenafil compared to those who did not.
“In brain cells from Alzheimer’s patients, researchers also
showed that sildenafil lowers levels of neurotoxic tau
proteins, which are known to be associated with AD when they
build up,” stated the Cleveland Clinic report. “They also found
that neurons treated with sildenafil expressed genes related to
cell growth, improved brain function, reduced inflammation and
other processes known to protect against the neural degeneration
associated with Alzheimer’s disease.”
This potential neuroprotective effect of GLP-1 agonists and PDE5
inhibitors open new doors for attacking AD from multiple angles
ensuring a more holistic approach to developing novel
treatments.
Protected IP
Annovis has taken the requisite steps to extend its intellectual
property. This week, the company filed three
new patents for innovative combination therapies involving
buntanetap. These patents cover the combination of buntanetap with
Trulicity, Viagra or a combination of all three, creating a unique
multifaceted approach to tackling neurodegeneration.
It’s a novel approach with unprecedented opportunity considering
AD is one of the most common neurodegenerative diseases in the
United States, impacting approximately 6.7 million
Americans, with expectations that the number will reach 13.8
million by 2060 without any new medical breakthroughs.
Speaking to the importance of the patents and the company being
successful in its mission, Maccecchini commented, “Our early data
suggests a strong synergistic effect from combining these drugs,
resulting in significant cognitive enhancement. The combination of
buntanetap with Trulicity and Viagra not only has the potential to
restore cognition to healthy levels, but also to improve it beyond
normal, offering new hope in the fight against dementia. Since
buntanetap has completed phase 3 studies as a standalone treatment,
and both Trulicity and Viagra are FDA approved, these combinations
are well positioned for phase 3 human trials.”
Key Players
There are certain diseases and health conditions that for
decades have gone grossly underserved because of the extreme
challenges related to developing new drugs. However, sometimes a
breakthrough happens that moves the needle, and majors start seeing
the potential return on investment as a development catalyst.
Neurodegenerative diseases certainly fit into this category, as do
GLP-1 and PDE5 drugs, with respect to the vast diversity they are
showcasing in recent years.
Eli Lilly
and Company (NYSE: LLY), which has a portfolio of neuroscience,
GLP-1 and PDE5 drugs, including being the owner of Trulicity and
tadalafil (Cialis), is also spearheading new approaches for
Alzheimer’s. In July, the FDA approved Kisunla(TM) (donanemab-azbt,
350 mg/20 mL once-monthly injection for IV infusion), Lilly’s
medicine for adults with early symptomatic AD, which includes
people with mild cognitive impairment (“MCI”) as well as people
with the mild dementia stage of AD, with confirmed amyloid
pathology.
Pfizer Inc.
(NYSE: PFE), the owner
of sildenafil (Viagra), is also advancing a novel GLP-1 candidate,
danuglipron, for the treatment of adults with obesity and without
type 2 diabetes. The
company has released topline data from its phase 2b clinical
trial, which showed the study met its primary endpoint
demonstrating statistically significant change in body weight from
baseline. “We believe an improved once-daily formulation of
danuglipron could play an important role in the obesity treatment
paradigm, and we will focus our efforts on gathering the data to
understand its potential profile,” said Pfizer R&D chief
scientific officer and president Mikael Dolsten, MD, PhD.
Novo Nordisk
(NYSE: NVO) is the owner of liraglutide (Victoza), the
aforementioned drug candidate that showed some impressive
data in a phase 2b clinical trial for AD. It is right on point
to the diverse use of a medication with its roots in diabetes.
Victoza is a once-daily noninsulin medicine that lowers blood sugar
and A1C approved for adults and children 10 years of age and older
with type 2 diabetes. It also is for adults with type 2 diabetes
with known heart disease where it has been shown to reduce the risk
of major cardiovascular events such as heart attack, stroke, or
death.
AbbVie
(NYSE: ABBV) recently announced positive topline results
from its pivotal phase 3 TEMPO-1 trial for tavapadon as a
monotherapy in early Parkinson's disease. “The TEMPO-1 data,
coupled with the previously reported TEMPO-3 adjunctive trial
findings, further support the potential of tavapadon for people
living with Parkinson's disease,” said AbbVie SVP, immunology,
neuroscience, eye care and specialty development, Primal Kaur, MD.
"This marks a significant step forward in our commitment to
enhancing our neuroscience portfolio following the strategic
acquisition of Cerevel Therapeutics and further demonstrates our
dedication to supporting patients at all stages of this challenging
neurological condition.”
Annovis Bio and other leading pharmaceutical companies are
driving progress in an array of serious disease treatments, with
innovative combination therapies showing promising results for AD
patients. As breakthroughs continue, there is growing hope for new
treatments that not only slow disease progression but also improve
cognitive function, offering renewed optimism for millions of
patients.
For more information about Annovis Bio Inc. (NYSE:
ANVS), please visit Annovis Bio
Inc.
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