January 8, 2024 -- InvestorsHub NewsWire -- via NetworkNewsWire
Editorial Coverage: Already proven to be a revolutionary
treatment for type 2 diabetes and weight loss, glucagon-like
peptide-1 (GLP-1) agonists now appear to have a multitude of
potential blockbuster therapeutic uses, according to recent
research. Obviously, diabetes remains a primary indication, given
the massive global need. However, the impact of this extraordinary
molecule extends far beyond type 2 diabetes. The reach of GLP-1
drugs has widened in ways its inventors likely never
imagined. Clinical
trials are underway testing GLP-1 drugs to treat
Alzheimer’s, Parkinson’s, and even drug addiction, plus there are
strong indications of therapeutic efficacy in heart disease and
chronic kidney disease, as well as a wide range of other
conditions, including weight loss. The newfound applications of
this super-drug re-enforce both the reach and impact
of Lexaria Bioscience Corp. (NASDAQ:
LEXX) (Profile). By supercharging GLP-1
drugs with its DehydraTECH(TM) drug-delivery formulation and
processing technology, Lexaria intends to improve both delivery and
efficacy of GLP-1 for diabetes and potentially a host of other
maladies. With several key studies on the near-term horizon,
Lexaria has positioned itself in the midst of these market
opportunities alongside others changing the landscape, such
as Pfizer Inc. (NYSE:
PFE), Merck & Company Inc.
(NYSE:
MRK), AstraZeneca PLC (NASDAQ:
AZN) and Novo
Nordisk (NYSE:
NVO).
- GLP-1 agonists are the hottest
drugs in healthcare today, with uses targeting multibillion-dollar
diabetes and obesity markets and much more
- Lexaria Bioscience is
utilizing its patented DehydraTECH drug-delivery platform to
improve the way active molecules enter the bloodstream upon oral
ingestion
- A pilot study showed that a
DehydraTECH-processed form of blockbuster Rybelsus (a GLP-1) was
more effective controlling blood glucose than standard
Rybelsus
- Lexaria recently received
final data from the study and plans to conduct additional human
studies during Q1 2024
Click here to view the custom infographic of
the Lexaria Bioscience
Corp. editorial.
GLP-1: A Therapeutic Oasis
GLP-1 agonists have emerged as the preferred weapons in the
fight against diabetes, a disease affecting some 422 million people
worldwide. Prolonged elevated blood sugar from diabetes results in
significantly higher risk for serious comorbidities such as kidney
disease, vision loss, heart and cardiovascular disease, and more.
Diabetes is often closely connected to obesity, a common global
health concern, and the relationship is disconcerting. Data
collected between 2017 and 2020 showed 41.9% of adults
in the United States are obese, and worldwide, obesity tripled
from 1975 to more than 1.9 billion in 2016. With diabetes and
obesity affecting some 25% of the world, the global impact on both
health and economy is enormous, with one study reporting a
conservative estimate of more than a $2
trillion global economic burden.
Little wonder the global diabetes drug market, estimated at
$61.87 billion in 2022, is projected to explode to ~$118 billion
by 2032. Similarly, product sales for obesity drugs are
forecast to reach $100 billion within a decade, and the most
promising drugs at the head of the pack are GLP-1 agonists.
With each new study, the horizon of GLP-1’s therapeutic
potential expands, painting a vibrant picture of a future where a
single molecule could tackle a multitude of human afflictions,
including neurological disorders (e.g., Alzheimer’s and
Parkinson’s), cardiovascular conditions (e.g., heart disease, high
blood pressure, atherosclerotic plaques, inflammation), cancer,
autoimmune disease (e.g., Crohn’s), and many new possibilities;
studies are investigating the efficacy of GLP-1 drugs on kidney
disease, liver disease, bone health and even aging.
With so many proven and potential blockbuster indications,
enhanced delivery and increased efficacy would supercharge the
impact of GLP-1 agonists. Lexaria
Bioscience Corp. (NASDAQ:
LEXX) intends to do just that with its patented
DehydraTECH platform developed to improve the way active molecules
enter the bloodstream upon oral ingestion. DehydraTECH has
demonstrated enhanced delivery of certain active molecules into
brain tissue, which has particular importance for centrally active
compounds via oral administration. Lexaria has also developed
DehydraTECH formulations for other applications demonstrating
superior bioabsorption when administered intraorally (sublingual or
tissues of the mouth).
The company’s initial focus is on diabetes and obesity with a
bevy of other conditions on tap for upcoming studies of the
disruptive drug-delivery platform, including oral nicotine where
its rapid and effective drug absorption into the bloodstream and
brain tissue is theorized as highly beneficial. The
company just
received final results from its first human pilot study of
GLP-1, and those results are very positive.
DehydraTECH Enhancing Approved Drugs
Lexaria began its DehydraTECH diabetes-related formal studies in
2022. The company’s first-generation DehydraTECH research in animal
studies reduced blood-sugar levels and lowered body weight. In
recent days, Lexaria’s results within its diabetes and weight-loss
study program have significantly improved, including results from
the company’s first human study investigating GLP-1. Eye-popping
results showed DehydraTECH-processed Rybelsus(TM) (oral
semaglutide) was more
effective at controlling blood glucose than standard
Rybelsus alone. That might be because DehydraTECH delivered more of
the GLP-1 drug into human bloodstream than did Rybelsus(TM) itself.
Lexaria may have changed treatment efficacy with a supercharged
GLP-1 agonist.
These results dovetailed with other details from the recent
study showcasing the potential for DehydraTECH to make a
blockbuster drug better. Rybelsus is one of the most popular drugs
in the diabetes market, posting sales of ~$1.63 billion in 2022 and
already posting $1.234 billion in sales during just the first half
of 2023. By comparison, Ozempic, a weekly injectable semaglutide,
posted sales of $6.174 billion in the first half of 2023.
Injectables may be the best-selling drugs, but they are the least
favorite delivery method and an impetus for a more powerful oral
drug.
Lexaria’s study was performed by a university research center
that compared a control group receiving a single dose of a Rybelsus
tablet to a treatment group receiving a matching dose of Rybelsus
that had been formulated using DehydraTECH processing-technology
enhancements. Data from the pilot study (n=7) showed the
DehydraTECH-processed Rybelsus led to sustained higher levels of
semaglutide in blood, faster achievement of peak drug delivery,
better control of blood glucose, and reduced side effects.
Twenty-four hours after administration, blood glucose levels in
the Rybelsus control group were unchanged from baseline, compared
to a 5.01% reduction for the DehydraTECH GLP-1 treatment group, an
obvious improvement. Furthermore, the data showed the control group
to experience a 21.7% spike in glucose levels after a meal, versus
just a 6.2% increase in the DehydraTECH treatment group.
Up Next: Building a Commercial Data Set. .
.
Lexaria intends to replicate and further validate the enormously
enhanced efficacy and reaffirm the safety of its technology in
larger-scale studies for statistically significant analysis as soon
as possible. Lexaria has been clear that it wants to attract a
commercial partner.
During the next several months, Lexaria is planning to begin
more human pilot studies expected to test at least one additional
GLP-1 drug as well as test an oral dissolvable that is not required
to be swallowed. It is also planning to start a very large and
comprehensive multiweek animal pharmacokinetic and efficacy
modelling study program using different DehydraTECH compositions
and different GLP-1 drug molecules. Although all study plans might
change, that animal study will specifically measure weight loss and
other performance indicators over a multi-week period. Lexaria is
also planning to begin a long-term stability test program to
discover whether DehydraTECH formulated GLP-1 drugs can avoid
refrigeration during storage, unlike existing injectable GLP-1
drugs that require costly refrigerated manufacturing and storage
conditions.
In Q2 2024, Lexaria intends to study DehydraTECH-GLP-1 in a
multiweek human clinical trial to examine both diabetes-related
control (in part via reduced blood sugar levels) as well as weight
loss and side effects.
It’s difficult to estimate the potential impact of Lexaria’s
DehydraTECH on the GLP-1 drug market. Lexaria is moving quickly to
build a thorough data set that it hopes will lead to an agreement
with one of the giant pharmaceutical players in the global GLP-1
space. However, with early indications of a manyfold increase in
efficacy, the technology could disrupt a booming
multibillion-dollar market.
The last time a drug-delivery technology achieved that, Novo
Nordisk agreed to pay $1.8 billion to acquire
Emisphere’s SNAC technology, which it placed into its Rybelsus
tablets. That’s right: the $1.8 billion technology already embedded
within every Rybelsus tablet was just bested by Lexaria’s
DehydraTECH.
. . . And Further Differentiation
While GLP-1 drugs are touted for their efficacy and compelling
safety profile, they still can trigger nausea, vomiting, diarrhea
and more. In addition, ongoing research is examining long-term
effects related to bone density and muscle loss. Improving side
effects is critical for market share as the GLP-1 market matures.
Lexaria is working to deliver on this front as well.
In the first human pilot study, DehydraTECH again showed
evidence of its prowess. Not a single one of the people receiving
DehydraTECH formulated Rybelsus experienced any moderate or severe
nausea or diarrhea, whereas the Rybelsus control tablets alone did
provoke moderate nausea and diarrhea.
Other benefits are realized in the aggregate through the value
of improved pharmacokinetics and delivery methods, namely lowered
costs and greater patient demand. Lexaria has protected its
DehydraTECH technology with a patent portfolio already comprised of
38 granted patents in the United States, Canada, Mexico, Japan,
Australia, India and the European Union, with more patent
applications pending around the world.
Changing Outcomes
GLP-1 drugs are arguably the hottest topic in healthcare today.
They’ve proven to have a positive effect on type 2 diabetes and a
meaningful impact on weight loss. New research indicates a plethora
of other potential blockbuster applications that could change
protocols and outcomes for millions of people with a myriad of
maladies. GLP-1 will likely stay in the spotlight for years to come
with numerous companies targeting improvements and market
share.
Pfizer Inc. (NYSE:
PFE) this month announced
topline data from the phase 2b clinical trial
investigating its oral glucagon-like peptide-1 receptor agonist
(GLP-1RA) candidate, danuglipron, in adults with obesity and
without type 2 diabetes. The study met its primary endpoint
demonstrating statistically significant change in body weight from
baseline.
Merck & Company Inc.
(NYSE:
MRK) is approaching GLP-1 agonists from different
angles. In August, Merck entered an exclusive licensing agreement
with Hanmi Pharmaceutical for the development, manufacture and
commercialization of efinopegdutide (formerly HM12525A), Hanmi’s
investigational once-weekly GLP-1/glucagon receptor dual agonist,
for the treatment of nonalcoholic steatohepatitis.
AstraZeneca
PLC (NASDAQ:
AZN), a global, science-led biopharmaceutical company, has entered into an
exclusive license agreement with Eccogene for ECC5004, an
investigational oral once-daily GLP-1RA for the treatment of
obesity, type 2 diabetes and other cardiometabolic conditions.
Preliminary results from the phase I trial have shown a
differentiating clinical profile for ECC5004, with good
tolerability and encouraging glucose and body-weight reduction
across the dose levels tested compared to placebo.
Novo
Nordisk (NYSE:
NVO), the owner of Ozempic(R), Rybelsus(R), Victoza(R)
and Wegovy(R), is a world leader
in diabetes and GLP-1 drugs. In the first nine months of 2023,
sales within diabetes and obesity care increased by 36% in Danish
kroner to DKK 153.8 billion (40% at CER (constant exchange rate),
mainly driven by GLP-1 diabetes sales growth of 45% in Danish
kroner (49% at CER) and obesity care growing by 167% in Danish
kroner to DKK 30.4 billion (174% at CER).
Pharma giants around the world are looking for ways to cement a
GLP-1 foothold whether it’s for diabetes, obesity or new
indications. It appears certain that GLP-1 is here to stay, and
indications for use will likely expand beyond expectations.
Companies that enhance efficacy and expand usage could prove to be
the biggest winners in the progression of GLP-1 drugs.
For more information about Lexaria Bioscience
Corp., please visit Lexaria
Bioscience Corp.
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