NetworkNewsWire Editorial Coverage
NEW
YORK, Oct. 3, 2024 /PRNewswire/ --
Pharmaceutical companies are demonstrating innovation by not only
developing new drugs but also exploring combination therapies and
repurposing existing drugs to address unmet medical needs. This
strategic approach holds promise for providing hope to millions of
patients suffering from historically challenging diseases.
Alzheimer's disease (AD) for example, has become a focal point of
this innovation, with recent U.S. Food and Drug Administration
(FDA) approvals of Leqembi and Kisunla — although these treatments
only slow cognitive decline rather than improve cognitive function.
New uses for approved glucagon-like peptide-1 (GLP-1) and
phosphodiesterase 5 (PDE5) inhibitor drugs show promise in treating
Alzheimer's, with companies such as Annovis Bio Inc. (NYSE:
ANVS) (profile) leading the way with treatments ready for
late-stage clinical trials. Beyond Alzheimer's, the pharmaceutical
industry is experiencing a surge of innovation across various
disease areas. Major players, including Johnson &
Johnson (NYSE: JNJ), Novartis (NYSE: NVS), Merck
& Co. Inc. (NYSE: MRK) and GSK plc (NYSE: GSK) are
at the forefront of medical innovation, tackling previously
intractable diseases.
- Annovis is leading the way in the development of buntanetap,
currently testing the drug in pivotal clinical trials for
Alzheimer's and Parkinson's diseases.
- The company has secured intellectual property for innovative
combination therapies involving buntanetap and other drugs,
including Trulicity(R) and Viagra(R), which work together to
enhance cognitive function.
- Annovis' planned phase 3 studies may evaluate both double
combinations (buntanetap with GLP-1 agonist or PDE5 inhibitor) and
a triple combination of all three drugs.
Click here to view the custom infographic of the Annovis
Bio editorial.
Buntanetap Targeting Alzheimer's Disease
Annovis Bio Inc. (NYSE: ANVS) is leading efforts to
develop innovative and safe treatments for neurodegenerative
diseases such as Alzheimer's. The company's main focus is enhancing
nerve cell health to improve cognition in such conditions, a target
that has proved elusive for peers. The company's flagship drug
candidate, buntanetap, has completed advanced-stage clinical trials
for both AD and Parkinson's disease (PD) and has shown compelling
results in both indications.
Earlier in the year, Annovis shared positive data from a phase
2/3 trial evaluating buntanetap as an oral therapy for early-stage
AD. This trial, which included 353 participants, assessed both the
drug's effectiveness alongside standard care, as well as providing
insight on the safety profile. The results demonstrated cognitive
improvements across all doses compared to placebo, with the 30mg
dose showing the greatest benefit, measured by the ADAS-Cog 11
scale. These findings aligned with prior studies (NCT04524351,
NCT02925650), with buntanetap also reducing key disease biomarkers
including neurofilament light (NFL), tau protein and the
inflammatory biomarker glial fibrillary acidic protein (GFAP).
Annovis is currently planning for a confirmatory phase 3 trial in
biomarker-positive early AD patients to support an anticipated New
Drug Application (NDA) submission.
Recently, Annovis expanded its approach by exploring
combinations of buntanetap with drugs such as Trulicity
(dulaglutide) and Viagra (sildenafil), either as individual
combination therapies or a three-prong approach utilizing all for
their unique strengths. The three drugs bring their own strengths
to the combination table. Trulicity, a popular GLP-1 agonist, has
been shown to improve brain glucose metabolism. Viagra is known to
enhance cerebral blood flow. Buntanetap inhibits the production of
neurotoxic proteins, including amyloid beta, tau, alpha-synuclein
and TDP-43, and improves the flow of information, offering a
potential to restore cognitive function in patients.
Next-Generation AD Opportunity
Annovis recently unveiled preclinical data demonstrating that
combining buntanetap with Trulicity in an Alzheimer's mouse model
yielded synergistic benefits. While both drugs individually
improved cognitive function, their combined impact surpassed that
of healthy controls by 16%, reinforcing the potential of
combination therapies for AD treatment.
It is theorized that the improvement as a combination is
undergirded by the neurotoxic inhibiting attributes of buntanetap
paired with Trulicity's ability to penetrate the blood-brain
barrier and normalize glucose metabolism. This groundbreaking
research marks the first instance of a treatment restoring
cognitive function beyond normal levels.
"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.
A Fresh Perspective on an Old Problem
The fight against neurodegenerative disease potentially could
get a boost from unexpected sources, as drugs traditionally used
for diabetes and erectile dysfunction (ED) are used for AD.
GLP-1 Agonists
Originally designed to treat type 2 diabetes, these drugs (such
as semaglutide and liraglutide) mimic a hormone that regulates
blood sugar. While helping diabetics control glucose, researchers
noticed an additional benefit: significant weight loss. This led to
the approval of drugs such as Wegovy for obesity treatment that act
by suppressing appetite and increasing fat burning.
The benefits do not stop there. Recent studies suggest GLP-1
drugs may also reduce the risk of heart disease, kidney disease and
stroke, and even possibly protect the brain from AD by reducing
inflammation, improving brain's insulin sensitivity and enhancing
neuroplasticity (the brain's ability to form new connections).
Early clinical trials are promising. Mid-stage data showed
Liraglutide (Victoza), a GLP-1 drug, to significantly minimized
brain shrinkage in memory, learning and language areas compared to
a placebo.
PDE5 Inhibitors
These medications (such as Viagra and Cialis), known for
treating ED where smooth muscle contraction is paramount, are also
being explored for AD. Although commonly used for their blood
pressure-lowering effects, preclinical studies suggest they can
improve synaptic function (communication between brain cells) and
cerebral blood flow while also enhancing cognitive abilities.
Currently, four oral PDE5 inhibitors are available in the United States: sildenafil (Viagra(R),
Pfizer), vardenafil (Levitra/Staxyn(R), Bayer), tadalafil
(Cialis(R), Eli Lilly), and avanafil (Stendra(R), Vivus).
Real-world data also paints a hopeful picture. Notably,
sildenafil (Viagra) is linked to a reduced risk of dementia in
patients who take it. Cleveland Clinic-led research discovered that
in Alzheimer's patients, sildenafil reduces levels of neurotoxic
tau proteins, known contributors to the disease. Additionally,
neurons treated with sildenafil exhibited enhanced cell growth,
improved brain function and reduced inflammation, all of which are
crucial for protecting against the neural degeneration associated
with Alzheimer's.
This promising research suggests both GLP-1 agonists and PDE5
inhibitors could have a neuroprotective effect, offering a new
approach to combatting AD. By targeting the disease from multiple
angles, these drugs hold potential for a more holistic treatment
strategy.
Growing Patent Estate
Annovis has taken a proactive step to protect its intellectual
property by filing three new patents for innovative
combination therapies involving buntanetap. These patents encompass
combinations with Trulicity and Viagra, as well as a synergistic
approach using all three drugs. The combination of these drugs
provides a competitive advantage to Annovis insomuch that
buntanetap has completed phase 3 studies as a standalone treatment
and the others are already FDA approved. To wit, Annovis is well
positioned to initiate phase 3 clinical studies.
Further, this multifaceted approach offers unprecedented
potential in combating neurodegeneration, especially considering
the growing prevalence of AD in the U.S. Neurodegenerative diseases
are on the rise, with Alzheimer's affecting nearly 6.7 million
Americans today. Without significant medical breakthroughs, this
number is projected to double to 13.8 million by 2060. With
buntanetap already completing phase 3 trials and Trulicity and
Viagra being FDA approved, these combination therapies are well
positioned for further clinical development under the protection of
Annovis' patents.
Other Innovators
A wave of innovative treatments is emerging, offering hope for
patients with previously challenging conditions. The outlook is
brightening as promising therapies are being developed, paving the
way for a brighter future in healthcare.
Johnson & Johnson (NYSE: JNJ),
a multinational pharmaceutical, biotechnology,
and medical technologies corporation, is focused on
healthcare innovation that builds a world where complex diseases
are prevented, treated and cured; and where treatments are smarter
and less invasive; and solutions are personal. Most recently the
company invested more than $2 billion
in new, advanced technology manufacturing facility in North Carolina to support robust portfolio
growth. The new facility will expand production of Johnson &
Johnson's innovative biologic medicines in areas including
oncology, immunology, and neuroscience; construction on the
state-of-the-art structure is slated to begin in the first half of
2025.
Novartis (NYSE: NVS) is an innovative medicines
company with research and development at its core. The company's
R&D engine powers an industry-leading pipeline that is focused
on delivering transformative medicines to fight disease, restore
possibility and help people live life on their own terms. The
company's researchers work across several diseases areas to drive
drug discovery and early development, while its development
organization leads the advanced clinical development of those
medicines. This work is powered by technology platforms that help
the company innovate across its core therapeutic areas:
cardiovascular, renal and metabolic, oncology, immunology and
neuroscience.
Merck & Co. Inc. (NYSE: MRK) is developing an
investigational GLP-1/glucagon receptor co-agonist: efinopegdutide
(MK-6024). The experimental drug efinopegdutide, which is being
developed as a treatment for nonalcoholic steatohepatitis
(NASH) and was granted Fast Track
Designation by the U.S. Food and Drug Administration (FDA) for this
treatment, also showed a weight-loss benefit, said CEO Robert Davis during the 45th Annual Goldman
Sachs Healthcare Conference.
GSK plc (NYSE: GSK) was at this year's Alzheimer's
Association International Conference, presenting four new abstracts
contributing to early science in neurodegenerative diseases. More
specifically, GSK was presenting results from the ZOSTER-122
retrospective, observational matched-cohort study in adults aged 50
years and over, which examines the potential association between
Shingrix (Recombinant Zoster Vaccine or RZV) vaccination and
reduced risk of dementia compared to two other vaccines.
These pharmaceutical players are working to find effective
treatments for diseases that for decades have been underserved.
Potential breakthroughs in the development of new drugs could mean
big success for these companies and, even more important,
significant benefits for the individuals suffering from these
diseases.
For more information about Annovis Bio Inc. (NYSE:
ANVS), please visit Annovis Bio Inc.
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