January 10, 2024 -- InvestorsHub NewsWire --
via NetworkNewsWire
Editorial Coverage: On Sept. 20, 2019, history was made
when the U.S. Food and Drug Administration approved Rybelsus as the
first oral glucagon-like peptide-1 (GLP-1) agonist for type 2
diabetes (T2D). However, it wasn't just a milestone for T2D
management. It was a turning point in medicine, opening the
floodgates to a universe of potential therapeutic applications for
this remarkable molecule. While undeniably transformative for
diabetes and weight loss, GLP-1's reach now extends far beyond,
likely surpassing even the wildest dreams of its creators. From
Alzheimer's and Parkinson's to drug addiction, clinical trials are
painting a stunning picture of GLP-1's versatility. And it doesn't
stop there. Strong evidence points to opportunities in heart
disease, chronic kidney disease and a plethora of other conditions.
The newfound applications of this super-drug re-enforce the
significant potential for Lexaria Bioscience Corp.
(NASDAQ:
LEXX) (Profile),
with its powerful DehydraTECH(TM) drug-delivery formulation and
processing technology that improves both delivery and efficacy of
GLP-1 for diabetes and potentially a host of other maladies.
Lexaria joins other companies, including Amgen Inc. (NASDAQ:
AMGN), Eli
Lilly and Company (NYSE:
LLY), Roche (OTCQX:
RHHBY) and WW
International Inc. (NASDAQ:
WW), that are committed to providing powerhouse
solutions in the fields of diabetes, weight loss and more.
- GLP-1 agonists are among the hottest
drugs in healthcare, with uses targeting multibillion-dollar
diabetes and obesity markets and much more.
- Lexaria Bioscience has developed
DehydraTECH drug-delivery platform, which is being shown to improve
pharmacokinetics of orally administered drugs.
- A pilot study evaluated a dose of the
GLP-1 drug Rybelsus to one processed with DehydraTECH, showing
Lexaria's tech improves the safety and efficacy of the drug.
- Lexaria issued final data from the pilot
study and is planning for multiple human and animal studies early
in 2024.
Click here to view the custom infographic of
the Lexaria Bioscience
Corp. editorial.
Diabetes and Obesity: A Growing Concern with a Glimmer
of Hope
Imagine a silent storm raging inside countless bodies, a chronic
battle against rising blood sugar. This is the reality for the 422
million people worldwide battling diabetes, a disease with
tentacles that reach far beyond elevated glucose levels.
Uncontrolled blood sugar dramatically increases the risk of
devastating comorbidities, including kidney disease, vision loss,
amputations, heart attacks, strokes and early death.
The storm often gathers strength in the wake of another global
health crisis: obesity. Data paints a disturbing picture
— 41.9% of U.S.
adults now obese, with the worldwide number ballooning to 1.9
billion in 2016 from about 650 million in 1975. This unholy
alliance of diabetes and obesity affects a staggering 25% of the
world and exacts a heavy toll, not just on health but also on the
economy. A conservative estimate puts the global economic burden
at more than $2
trillion.
Amid the storm clouds, a glimmer of hope emerges. Enter GLP-1
agonists as a new frontline defense. These drugs mimic a natural
gut hormone, prompting the body to produce insulin, regulate blood
sugar and even suppress appetite. They're proving to be powerful
weapons in the fight against both diabetes and obesity, offering a
chance for a diabetes patient to reclaim control of their blood
sugar.
The rising rate of diabetes and obesity diagnoses is creating
unprecedented demand for innovative treatments. In 2022, the global
diabetes drug market alone surged to $61.87 billion, a figure that
pales in comparison to the projected tsunami of spending
reaching ~$118
billion by 2032. Scientists are counting on GLP-1 drugs to
fight obesity too, another market figured to also top $100 billion
in the next decade.
GLP-1 agonists, already blockbusters for diabetes and obesity,
are just getting going. That's the potential Lexaria
Bioscience Corp. (NASDAQ:
LEXX) unlocks with its DehydraTECH platform. The
DehydraTECH solution is designed to enhance drug delivery and
efficacy, not only orally but even into the brain for centrally
acting compounds. Consider bypassing injections and unlocking new
treatment possibilities — that's DehydraTECH's revolutionary
promise. With proven benefits for oral medications and potential
for dissolvable oral applications, Lexaria positions itself at the
forefront of maximizing the impact of these life-changing
drugs.
Lexaria is initially focused on diabetes and obesity as the
low-hanging fruit, but the company isn't just tackling these
indications with its DehydraTECH platform; it's aiming for a whole
menu of medical victories. This disruptive drug-delivery tech
boasts faster, better absorption into both bloodstream and brain,
making it applicable for conditions such as oral nicotine (where
rapid delivery could be a major benefit). This isn't simply
hyperbole. Lexaria recently announced its first human
GLP-1 study, with compelling results fueling excitement for a
future where DehydraTECH supercharges the molecule's effect. While
diabetes and obesity are tremendous market opportunities, Lexaria
is thinking bigger as a platter of medical hope.
DehydraTECH + Rybelsus(TM)
Lexaria Bioscience is aiming to plant its flag in the GLP-1
agonist space with its DehydraTECH platform. After early animal
studies hinted at DehydraTECH's blood-sugar-lowering abilities, the
company's first human test has impressed. DehydraTECH-powered
Rybelsus(TM) (oral semaglutide), a blockbuster diabetes
drug, lowered
blood glucose levels much better than the original alone,
possibly thanks to its superior delivery punch to deliver more of
the GLP-1 drug into human bloodstream than did Rybelsus itself.
It's early in the game, but Lexaria commands attention to possibly
improve the standard of care with a supercharged GLP-1 agonist.
Rybelsus is a top-selling drug in the diabetes market, posting
sales of ~$1.63 billion in 2022 and recording $1.234 billion in
sales during just the first half of 2023. Moreover, Ozempic, a
weekly injectable semaglutide, registered sales of $6.174 billion
in the first half of 2023. Recent studies by Lexaria show their
platform boosts Rybelsus' blood-sugar-bludgeoning power, which
certainly opens discussions about the potential. The stakes are
high to find the most efficacious oral medication considering that
injections are a pain point for patients.
The research, conducted by a university researcher, completed a
head-to-head comparison of Rybelsus alone versus
DehydraTECH-formulated Rybelsus. Compared to a single dose of
standard Rybelsus, DehydraTECH-powered Rybelsus showed sustained
higher drug levels, quicker peak delivery, superior blood sugar
control and even fewer side effects. The seven-participant study
hints at a future where oral diabetes drugs could pack a much
bigger punch, potentially giving injections a run for their
money.
The data speaks volumes. At 24-hours post administration,
blood-sugar levels in patients treated with Rybelsus were unchanged
from baseline, while those in the DehydraTECH group experienced a
5.01% reduction, a significant improvement. Further, while the
control group's glucose soared 21.7% after a meal, DehydraTECH kept
that number locked down to a mere 6.2%, showcasing its superior
blood sugar control.
Besting a $1.8 Billion Technology
Armed with this data, Lexaria's is moving forward with a purpose
to validate and capitalize on its initial DehydraTECH results. The
company is fast-tracking larger trials to confirm the improved
efficacy and safety shown in the most recent research while its
focus is firmly fixed on a commercial partnership.
Moving forward, Lexaria is planning to initiate multiple studies
further proving the prowess of DehydraTECH. For starters, the
company will conduct additional human pilot studies in the next
several months to examine another GLP-1 drug as well as evaluate a
swallow-free oral dissolvable. It will also launch a multiweek
animal pharmacokinetic and efficacy trial to optimize DehydraTECH
for weight loss and other performance metrics. Elsewhere, the
company is in the planning stages for a long-term stability test
program for the purpose of determining if DehydraTECH-formulated
GLP-1 drugs can go unrefrigerated during storage, unlike today's
injectable GLP-1 drugs, a factor that will reduce cost and increase
logistic simplicity.
Beginning in the April–June quarter, Lexaria has intentions to
study DehydraTECH-GLP-1 in a multiweek chronic human trial. In this
study, the company will gain insight in both diabetes-related
control (in part via reduced blood sugar levels) as well as weight
loss and side effects.
Predicting the DehydraTECH impact on the GLP-1 market is a
difficult task at this point. The company is rapidly building a
data set with the hopes of sealing a deal with an interested
pharmaceutical giant. With whispers of efficacy multiplying and
side effects diminishing, the potential to disrupt a
multibillion-dollar market is, arguably, an achievable target.
To put this into perspective, understand that the last time a
drug-delivery technology achieved such an improvement, Novo Nordisk
agreed to pay $1.8 billion to acquire
Emisphere's SNAC technology, subsequently putting the
technology into Rybelsus tablets. That bears repeating, considering
the $1.8 billion technology currently embedded in Rybelsus tablets
was just outperformed by DehydraTECH technology.
Proving More Differentiation
GLP-1 drugs are undoubtedly popular due to their efficacy and
intriguing safety profile compared to other drugs for the same
indications, but they are still far from perfect. Their side
effects include diarrhea, vomiting, nausea and more. Plus, they are
still somewhat new, so long-term research is ongoing to evaluate
delayed effects that could be related to bone density and muscle
loss. To wit, DehydraTECH improving pharmacokinetics to reduce side
effects can be instrumental in gaining market share in the
future.
In the pilot study, DehydraTECH impresses on this front. None of
the participants treated with DehydraTECH-formulated Rybelsus
experienced any moderate or severe nausea or diarrhea. Conversely,
those receiving the Rybelsus control tablets dealt with moderate
nausea and diarrhea.
Lexaria isn't just about blockbuster potential, it's about smart
business. DehydraTECH delivers a double whammy: lower costs for
pharma giants and higher demand from patients seeking better
delivery and efficacy. And to lock this golden goose in, the
company has built a fortress of patents – 38 already granted and
counting across the globe.
Only the Beginning
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.
Additional companies and studies are investigating the efficacy of
GLP-1 drugs on kidney disease, liver disease, bone health and even
aging.
Amgen
Inc. (NASDAQ:
AMGN) is developing Maridebart
cafraglutide (formerly AMG 133), or Mari for short. Mari
is a gastric inhibitory polypeptide receptor ("GIPR") antagonist
and GLP-1 receptor agonist. It is being investigated in a phase 2
trial for the treatment of obesity with more than 640 patients,
with and without diabetes, enrolled in the study.
Eli
Lilly and Company (NYSE:
LLY) recently announced that the U.S. Food and
Drug Administration had approved its Zepbound(TM)
(tirzepatide) for chronic weight management, a powerful
new option for the treatment of obesity or overweight with
weight-related medical problems. Adults taking Zepbound in a
clinical trial lost on average 48 pounds at the highest dose.
Zepbound is the first and only approved treatment activating two
incretin hormone receptors, GIP and GLP-1, to tackle an underlying
cause of excess weight.
Roche (OTCQX:
RHHBY) announced last month that it
had entered into
a definitive merger agreement to acquire Carmot
Therapeutics Inc., a privately owned U.S. company based in
California. Carmot's R&D portfolio includes clinical-stage
subcutaneous and oral incretins with best-in-class potential to
treat obesity in patients with and without diabetes, as well as a
number of preclinical programs. The announcement noted that
existing clinical data for Carmot's assets, especially the lead
asset CT-388, suggests potential to achieve and maintain weight
loss with differentiated efficacy.
WW
International Inc. (NASDAQ:
WW) last month launched a
new behavior-change program designed to support the unique
needs of individuals on GLP-1 medications. The WeightWatchers GLP-1
Program was developed by a team of obesity specialists, clinicians,
behavior-change scientists, dietitians and fitness experts to solve
a gap in the market as members navigate life on new weight-loss
medications.
GLP-1 has transcended its initial promise — its story is
now a thrilling saga of scientific exploration and medical triumph.
The implications are vast, not only for the millions struggling
with diverse ailments but for the future of medicine itself. This
is just the beginning. The curtain has risen on a new era, where
GLP-1, the once-humble diabetes drug, stands poised to rewrite the
script for countless medical journeys.
For more information about Lexaria Bioscience
Corp., please visit Lexaria
Bioscience Corp.
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