November 1, 2023 -- InvestorsHub NewsWire -- via NetworkNewsWire
Editorial Coverage: GLP-1 agonists have become incredibly
popular obesity drugs, reshaping the standard of care as people
increasingly turn to the new class of drugs in lieu of conventional
weight-loss procedures. There is a growing body of clinical
evidence showing GLP-1 agonists safely control blood sugar
(glucose) levels and deliver tremendous positive outcomes, such as
a recent New England
Journal of Medicine study reporting weight loss of 49 to
52 pounds. As good as GLP-1 agonist are, they can get better, which
is part of the mission of Lexaria Bioscience Corp.
(NASDAQ:
LEXX) (Profile), a global innovator in drug-delivery
platforms. The company started diabetes-related formal studies in
2022 evaluating its DehydraTECH(TM) platform, which showed lower
blood-sugar levels and decreased body weight. This compelling data
is undergirding the next phase of research, new human and animal
studies for the purpose of demonstrating DehydraTECH processing can
make GLP-1 drugs even more effective and more accessible. Positive
developments on DehydraTECH could catch the attention of companies
dedicated to developing drugs that support better health— companies
such as Johnson & Johnson
(NYSE:
JNJ), Sanofi (NASDAQ:
SNY), Amgen (NASDAQ:
AMGN), and Novartis AG (NYSE:
NVS).
- Lexaria’s DehydraTECH is a
platform technology that seamlessly integrates in manufacturing
processes to enhance delivery of API payloads, subsequently
improving pharmacokinetics and reduce side effects
- Lexaria is researching the
effect of DehydraTECH on oral performance of GLP-1 drugs for
diabetes and weight loss, markets expected to climb to $200 billion
annually
- DehydraTECH is scalable and
shown to have utility for a multitude of applications, including
oral nicotine products, for which Altria has secured rights from
Lexaria
- DehydraTECH promotes rapid
uptake and better efficacy through less expensive, oral
administration, as validated through laboratory and clinical
testing
Click here to view the custom infographic of
the Lexaria Bioscience
Corp. editorial.
A Dire Need for New Therapies
The number of people dealing with chronic, serious health
challenges, including diabetes, obesity and hypertension, is
spiraling out of control. The U.S. Centers for Disease Control and
Prevention estimates that 37.3 million Americans have diabetes
today, while nearly 100 million more adults have prediabetes.
What’s more, an estimated 8 out of 10 don’t even know they are
prediabetic and are unaware of the potential problems they could
face in the future. Worldwide, the numbers are equally depressing.
The World Health Organization estimates 422 million people were
living with diabetes in 2014, a four-fold increase from 1980.
Obesity and hypertension are common culprits in diabetes, and
diagnoses have reached epic proportions, including 41.9% incidence
in the U.S. in 2017. Globally, the number of obese people is a
staggering 1.9
billion, lending some color as to why diabetes rates are
spiking. And WHO reports that an estimated 1.28 billion adults
worldwide have hypertension.
Numbers like these lead to astronomical market
opportunities. Markets and
Research sees the global diabetes drug market at $63.1
billion in 2021 on its way to $82.93 billion in 2027. Without
question, one of the most popular type of diabetes medicines to hit
the market in recent years are GLP-1 (glucagon-like peptide-1)
receptor agonists. These work by imitating the effects of GLP-1, a
hormone involved in regulating glucose and hunger.
Lexaria
Bioscience Corp. (NASDAQ:
LEXX) has amassed highly compelling data since initiating
diabetes-related formal studies last year. The effects have been
multifold, comprised of lower glucose levels, body weight and
triglyceride levels with the added perk of increased locomotor
activity. This positive data has set the stage for Lexaria to widen
its diabetes study program, namely using DehydraTECH to process and
deliver GLP-1 drugs either alone or in combination with other
compounds.
Completed work on DehydraTECH has repeatedly shown it to improve
therapeutic profiles of active pharmaceutical ingredients (“APIs”).
The DehydraTECH process improves the way APIs enter the bloodstream
through oral administration, while further improving the
pharmacokinetics of several types of drugs, including PDE5
inhibitors and antiviral medicines. Moreover, the technology aids
in APIs crossing the blood-brain barrier, which can potentially
unlock new medicines for areas of great unmet medical need, such as
neurodegenerative brain diseases and addictions.
Now diabetes, obesity and hypertension are targets too, making
Lexaria’s portfolio all the more attractive.
Lexaria intends to initiate new human and animal studies to
examine GLP-1 drugs processed with DehydraTECH. Some of these drugs
are the most highly valued today, such as Wegovy(R), Rybelsus(R)
and Ozempic(R). Outcomes with evaluate DehydraTECH’s ability to
improve bioavailability, cost effectiveness, tolerability,
weight-loss potential, management of diabetes and more. This puts
Lexaria at a key inflection point where biotechs can surge in
value, according to calculations proffered by Bay Bridge
Bio.
Understanding DehydraTECH
Years of work have gone into developing DehydraTECH to position
it as an integral component to the next generation of drugs.
Obviously high tech, the platform is brilliant in its design and
simplicity, easily integrated into the formulation and
manufacturing process of existing or new orally delivered or
topical products.
The DehydraTECH process includes mixing the API with specific
fatty acids and infusing the combination into a substrate material.
That is followed by a controlled dehydration synthesis processing
to associate the payload and fatty acids together at a molecular
level. Next, the newly combined molecules go through a final
product production, with the output being a variety of doses in
different forms, such as capsules or pills.
Tasteless and odorless, the end product works harmoniously with
physiological systems. The API is absorbed more quickly into brain
tissues and the bloodstream. Effectively, Lexaria has taken a
highly complex process and turned it into a scalable platform
easily integrated into systems for making drugs today and those of
the future.
A New Chapter in Weight-Loss Medicines
There is a long list of drugs that were touted to be
blockbusters for weight loss that ultimately failed miserably.
Ephedra, Meridian, and Fen-phen come to mind. With 1.9 billion
obese people worldwide, it is not difficult to understand why
everyone from drugmakers to analysts to doctors and patients get
excited about safely and effectively tapping the market.
Where those drugs have failed, GLP-1 drugs are succeeding and
reversing the negative stigma of weight-loss drugs. Lexaria is set
to play a key role in shepherding in the next generation of these
drugs. The company
said in September that its planned trials of new
formulations of GLP-1 drugs “could enable drug delivery via oral
capsule at lower costs than current injectables, with reduced side
effects and enhanced health benefits.” This is company maker
potential, as Lexaria stands alone with DehydraTECH, with nothing
else like it currently available.
GLP-1 drugs are experiencing booming sales by taking a new
route, a pathway known as a “mechanism of action.” The drugs are
remarkably good at activating hormones that regulate glucose while
concurrently reducing appetite and stomach emptying. Clinical
trials have shown risks to be outweighed by benefits, leading to
several new drug approvals by the FDA for weight control and
management of type 2 diabetes. If addition, research has emerged
that GLP-1 drugs show potential to be effective in curbing
cravings for addictions, such as alcohol and nicotine,
more indications that Lexaria can put in its crosshairs in the
future for use with DehydraTECH.
Good Becomes Great
GLP-1 drugs are impressive, but they are not perfect. This
relatively new class of drugs may be associated with certain
adverse effects that can keep many people from tolerating the
medicine. There are a spate of articles available on the web
detailing the potential for side
effects, including nausea, vomiting and potentially even
stomach paralysis and pancreatitis. The drugs have even been the
topic of an investigation by European regulators looking into
increased risk of suicidal thoughts in patients on the
medications.
To wit, there is a tremendous opportunity to make modifications
to these and other drugs to control or even eliminate serious
negative effects. What would the value be to improve a blockbuster?
For Lexaria, DehydraTECH has the potential to mitigate adverse
events by either improving the delivery process or increasing the
effectiveness, which can mean lower doses or fewer side effects —
or both. Based upon the work by Lexaria with other drugs that
showed a marked reduction in negative side effects, it seems
plausible that a similar positive effect could be achievable in
GLP-1 drugs.
In addition, most approved GLP-1 drugs are injectables, not the
ideal method for most patients. Plus, injectables are more
expensive for both the manufacturer and patient. It is not uncommon
for a monthly regimen of a GLP-1 injectable to cost up to $900. If
successful in developing an oral option, Lexaria could find itself
in an enviable position in a GLP-1 drug market forecast to
reach $150 billion
to $200 billion. If so, the days of a $15 million market cap
for Lexaria could be ancient history.
Heavily Protected
Lexaria has an impressive patent estate protecting its unique
technology. The IP portfolio includes 37 domestic and international
patents spanning antiviral drugs, specific molecules for
hypertension and central nervous system disorders, nicotine, NSAIDs
(non-steroidal anti-inflammatory drugs) and vitamins. Management is
relentless in its patent pursuit, with more pending globally to
further cement DehydraTECH’s utility, including uses for
hypertension, hormone treatments and other drug formulations.
The company is starting to get noticed by major players. Tobacco
behemoth Altria has already licensed DehydraTECH, agreeing to pay
Lexaria royalties on future oral nicotine product sales. The idea
is DehydraTECH could be instrumental in making reduced risk
non-combustible nicotine products for the purpose of reducing the
millions of deaths each year attributed to cigarette smoking. For
many companies, this alone would be enough to get investors
excited, but for Lexaria, it’s just one potential revenue
stream.
Train Just Getting Going
GLP-1 drugs are definitely a hot topic, but the science is still
relatively young. Companies such as Lexaria have the potential to
improve outcomes and expand into an array of new areas. The company
is not alone in its pursuit of new drugs and delivery methods to
give caregivers and patients new options. In reality, it is still
early in what could be one of the most exciting areas of medicine
in the coming decades by providing relief to arguably two of the
areas of greatest need worldwide.
Johnson
& Johnson (NYSE:
JNJ) is one of the world’s largest healthcare
companies, with several units contributing to the top and bottom
lines. The company’s Medtech segment, which relies in part on
demand for gastric bypass and other bariatric surgeries, generated
third-quarter sales of $7.46 billion, up from $6.78 billion in the
year prior quarter. CEO and
chairman Joaquin Duato sees potential synergies for
surgery and GLP-1 meds, saying in a Q3 call, “Overall, when we talk
to surgeons, bariatric surgeons, what they see is a complementary
role of surgery and GLP-1s and many of them comment on the fact
that they could see a tailwind for bariatric surgery down the road
given this complementary nature, the increased awareness about
obesity, more patients seeking treatment.”
Sanofi (NASDAQ:
SNY) made an important move earlier this year to
bolster its portfolio, agreeing to pay $2.9 billion
to acquire Provention Bio Inc., a U.S.-based,
publicly traded biopharmaceutical company focused on intercepting
and preventing immune-mediated diseases including type 1 diabetes.
The transaction added an innovative, fully owned, first-in-class
therapy in type 1 diabetes to Sanofi’s core asset portfolio in
General Medicines and further drives its strategic shift toward
products with a differentiated profile.
Amgen
(NASDAQ:
AMGN) is developing maridebart
cafraglutide (formerly AMG 133) for obesity. Amgen is
conducting a phase 2 study of maridebart cafraglutide, a
multispecific molecule that inhibits the gastric inhibitory
polypeptide receptor (“GIPR”) and activates the glucagon-like
peptide 1 (GLP-1) receptor in overweight or obese adults with or
without type 2 diabetes mellitus. Last year, the company presented
data on a first-in-human study that evaluated the safety,
tolerability, pharmacokinetic and pharmacodynamic effects of AMG
133 in people with obesity and without diabetes (NCT04478708) at
the 20th World Congress of Insulin Resistance, Diabetes and
Cardiovascular Disease (WCIRDC) Hybrid Conference.
Novartis AG (NYSE:
NVS) is reimagining medicine to improve and
extend people’s lives. As a leading global medicines company,
Novartis uses innovative science and digital technologies to create
transformative treatments in areas of great medical need. The
company is currently conducting an efficacy, safety, tolerability
and dose-finding study of XXB750 in resistant hypertension
patients. The purpose of the 20-week randomized double-blind study
is to evaluate the efficacy, safety and tolerability of different
doses of XXB750 administered as subcutaneous injections, compared
to placebo.
Studies indicate that the combined demographic for diabetes,
hypertension and weight loss have potential to be among the largest
in the world. The recent emergence of new treatment options that
are showing significant success have sparked enormous global
potential.
For more information about Lexaria Bioscience
Corp., please visit Lexaria
Bioscience Corp.
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