August 10,2022 -- InvestorsHub
NewsWire--NetworkNewsWire Editorial Coverage: In medicine,
there is a term called "clinical inertia," or the case of what
someone doesn't know — or what they ignore — could kill them.
Simply put, it means failing to start or intensify a therapy when
appropriate, which leads to advanced or chronic disease. It is
particularly appropriate with a silent killer such as hypertension,
a condition that all too often goes untreated, becoming a culprit
in morbidity and mortality from cardiovascular, kidney and other
serious diseases. Hypertension, or high blood pressure, stats
continue to trend the wrong way, showing hundreds of thousands of
people dying each year while costs of the disease are a major
burden on already strained healthcare systems globally. Truth be
told, hypertension is generally treatable with lifestyle changes
and any number of prescription drugs, but most of the 1.28
billion people worldwide with high blood pressure go
untreated. Because high blood pressure symptoms can be benign,
patients would often rather go untreated than deal with unpleasant
side effects of today's drugs. A new, safer option made available
through Lexaria Bioscience Corp. (NASDAQ: LEXX)
(Profile) may
offer blockbuster potential. Lexaria, a global innovator in
drug-delivery platforms, is working its way through the FDA
pathway. Lexaria completed the pre-investigational new drug ("IND")
application meeting process for its newest DehydraTECH(TM) delivery
system with the U.S. Food and Drug Administration ("FDA") and is
proceeding with plans to file an IND as soon as possible and begin
clinical studies shortly thereafter. Quietly going about its
business, Lexaria maintains a low market capitalization compared to
bigger peers, such as Jazz
Pharmaceuticals plc (NASDAQ: JAZZ), Johnson & Johnson
(NYSE: JNJ), United Therapeutics
Corporation (NASDAQ: UTHR) and Bristol-Myers Squibb
(NASDAQ: BMY), a fact the company hopes to change by
moving through the FDA process, where met milestones often equate
to higher valuations.
- The global market for drugs
treating hypertension is forecast to climb from $24.17 billion in
2020 to $27.81 billion in 2025.
- The economic burden of
hypertension was $131 billion in 2020, while the disease was
culpable in the death of more than 670,000 Americans.
- Lexaria's patented DehydraTECH
has been shown in laboratory, human studies to improve
bioavailability of APIs to improve anti-hypertension therapy.
- The most recent hypertension
study hit a major milestone, while the company completed a highly
constructive pre-IND application meeting with the FDA to plan the
development of the company's DehydraTECH treatment of
hypertension.
Click here to view the custom
infographic of the Lexaria Bioscience
Corp. editorial.
Nothing Slowing This Persistent Killer . . .
Yet
Blood pressure ("BP") is the measure of the force of blood
pushing against artery walls as it courses throughout the body.
While levels change throughout the day based on activity, normal BP
is 120 over 80, meaning the pressure measurement is 120 mmHG when
the heart beats and 80 mmHG in between heartbeats. Persistent high
readings are considered hypertension and can result in increased
chances of life-threatening complications such as heart disease,
stroke, kidney and brain disease, among other things. A
comprehensive study published in The
Lancet shows hypertension cases in people aged 30 to 79
doubled worldwide from 1990 to 2019.
Today's approved drugs for hypertension are diverse, including
alpha-blockers, beta-blockers, diuretics, ACE inhibitors, ARB
inhibitors and other options for drug-resistant hypertension. Given
the prevalence, it's no small market. ReportLinker last year
estimated the global anti-hypertensive drugs market at $24.17
billion in 2020 with steady growth to $27.81 billion in 2025. The
economic burden is staggering, averaging $131 billion annually
according to the Centers for Disease Control and Prevention. Each
year, more than 670,000 deaths in the United States are attributed
to hypertension as a primary or contributing cause.
A recognized global innovator in drug-delivery
platforms, Lexaria
Bioscience Corp. (NASDAQ: LEXX) has its sights set on
delivering a new, safe, effective and tolerable hypertension
therapeutic that can slow the pervasive trend for the good of
patients and healthcare systems alike. Lexaria's DehydraTECH
improves the way active pharmaceutical ingredients ("APIs") enter
the bloodstream by promoting healthier oral ingestion methods and
increasing the effectiveness of fat-soluble active molecules. The
technology has been evaluated extensively across in vivo, in vitro
and clinical research demonstrating that it promotes rapid
absorption and improved effectiveness via oral delivery at a
less-expensive cost point.
Moreover, implementation of DehydraTECH technology into
production lines is relatively easy, achievable with the addition
of only a few steps into the formulation and manufacturing of oral
or topical products, albeit new or existing. During these new
steps, the API is combined with suitable fatty acids with the
mixture then infused into a substrate. From there, a controlled
dehydration synthesis process associates the payload and fatty
acids at a molecular level for integration into the final product
at the specified form factor.
Lexaria has an extensive patent franchise covering the
DehydraTECH intellectual property. There are 26 granted patents in
the United States, the European Union, Australia, Japan, Mexico and
India, with about four dozen more patents pending.
Strong Clinical Evidence
Lexaria is emerging as a pioneer of innovation with the
DehydraTECH platform technology and its spate of potential
applications with potential to improve pharmacokinetics in
patient-friendly delivery methods. In doing so, the company is
amassing a collection of evidence showcasing the prowess of
DehydraTECH. For instance, a 12-patient study in 2018 resulted in a
317% improvement in substance delivery to the human bloodstream at
30 minutes after ingestion, followed by more studies this year
specific to improved bioavailability specific to hypertension.
The most recent studies — HYPER-H21-1, HYPER-H21-2 and HYPER-H21-3 — speak
volumes about the opportunity for DehydraTECH in hypertension.
HYPER-H21-1 was a 24-person trial that evidenced rapid and
sustained drop in blood pressure. The changes were especially
notable in systolic pressure (the first number in BP readings, when
the heart is beating) in stage 2 hypertensive patients. HYPER-H21-2
built on that data, adding info from a 16-patient study that
exhibited a 23% average reduction in overnight blood pressure and
reduced arterial stiffness, indicating a durable response.
HYPER-H21-3, also a 16-person study, witnessed attenuated pulmonary
artery systolic pressure by approximately 5 mmHG or
41% overall in male participants.
Importantly, all of the clinical work continued to build upon a
robust safety and tolerability profile for DehydraTECH therapy.
Marching Towards an IND with FDA
Lexaria has just announced it has successfully completed its
pre-IND meeting with the FDA — a vital milestone. Now Lexaria is
working to complete its planned IND-enabling program, and has early
approval to pursue a coveted 505(b)(2) drug pathway for its
DehydraTECH drug-delivery platform. In doing so, Lexaria is
progressing smoothly through its most comprehensive hypertension
study yet: HYPER-H21-4. On July 27, 2022, Lexaria
reported that dosing in the study had been completed,
adding that no serious drug-related adverse events had been
reported.
The study was structured as a randomized, double-blinded,
placebo-controlled, crossover study slated to enroll at least 60
patients. A total of 64 patients were enrolled and treated either
with the experimental therapy or placebo. The highest dose of the
Lexaria drug was ~5 mg/kg/day, a level substantially lower than
maximum dose levels for similar drugs on the market today. The
lower dosing level can have big implications for Lexaria, as lower
doses are theorized to mitigate negative side effects of
hypertension drugs, such as elevated levels of liver enzymes.
"Demonstrating a noteworthy safety and tolerability profile
relative to conventional anti-hypertensive medications is one of
Lexaria's major goals with this program, and avoiding serious
adverse events at clinically efficacious doses will be a primary
requirement to achieve eventual regulatory marketing
authorizations," said Lexaria CEO Chris Bunka.
The primary outcome of the study is the impact of the drug
related to 24-hour ambulatory blood pressure, where blood pressures
are recorded automatically multiple times during the day and night.
Secondary outcomes abound, including a measure of effect on
vascular health, electrocardiogram analysis, MRI examinations of
brain structure and function, renal and hepatic analysis, readings
of blood biomarkers, sleep quality, daytime sleepiness and sleep
disorders, actigraphy, geriatric depression scale, perceived stress
and Beck anxiety inventory.
While safety and efficacy as related to ambulatory blood
pressure are top priorities, the abundance of secondary data should
not be underappreciated. Lexaria wants to cull all this information
as part of its broader strategy to develop DehydraTECH as a true
platform technology. Understanding a full spectrum of effects could
underpin other drug-development initiatives.
Each Step Adds Value (And It's Not Linear)
According to the FDA, there are five
steps to developing a new drug. These include 1) discovery
and development; 2) preclinical research; 3) clinical research; 4)
FDA drug review; and 5) FDA post-market drug safety monitoring. In
the eyes of the investment community, the third step, or clinical
research, which is broken into Phase 1, 2 and 3 human trials, is
crucial.
During this step, valuations can surge on the market being
addressed. Take note that only a small percentage of drugs (fewer
than 250 out of 5,000 to
10,000) exit the discovery stage to make it to preclinical
research, and fewer yet make it to human trials. Thus, it is not
uncommon for nonrevenue biotechs and pharmas to have market
capitalizations in the hundreds of millions by phase 2 and billions
of dollars in phase 3 trials.
Lexaria is on the cusp of the FDA's steps 2 and 3 with its mix
of lab and clinical work in the DehydraTECH program generating a
solid understanding of safety, tolerability and efficacy. The
company's current market cap is about $17 million.
To provide a little backdrop as to what can happen with
valuations for novel drugs, understand that Jazz Pharma
paid $7.2 billion for GW Pharma after GW Pharma obtained
marketing approval for its patented Epidiolex to treat two rare
types of pediatric seizure disorders. In March, Pfizer
shelled out $6.7 billion for Arena Pharmaceuticals to gain
control of Arena's diverse portfolio of drugs. Big pharma is
looking to reload pipelines with promising drugs and new revenue
streams.
Follow the Trend to Value
At this moment, there is no real reason to think that the
hypertension trend is going to change direction solely upon today's
marketed drugs. The silent killer typically begins with unhealthy
lifestyles and is frequently accompanied by obesity, a fellow
killer in its own right with diagnoses running rampant as evidenced
by 42% of
American adults clinically obese. With that in mind,
anti-hypertension drugs should continue to command high value for
the foreseeable future.
Jazz
Pharmaceuticals plc (NASDAQ: JAZZ) is best known
for its deep pipeline and approved drugs in the areas of
neuroscience and oncology and an optimal example of building value
by moving through the FDA process. For instance, shares were
trading around $125 in December when Jazz and partner
PharmaMar initiated a phase 3 trial of Zepzelca(R) (lurbinectedin)
for the treatment of patients with relapsed small cell lung cancer.
Two days later, Jazz said the first patient was enrolled in a
global phase 2b trial evaluating the safety and efficacy of
suvecaltamide for the potential treatment of moderate to severe
essential tremor ("ET"). The stock has remained in an uptrend
since.
The Janssen Pharmaceutical
Companies of Johnson & Johnson
(NYSE: JNJ) are committed to developing a
portfolio of pulmonary arterial hypertension ("PAH") drug
candidates; that development includes sponsoring the largest
randomized, controlled trial ever conducted in PAH patients. PAH is
a rare type of high blood pressure in the lungs that occurs when
the organ's tiny arteries narrow, stiffen and block blood flow,
ultimately leading to right-side heart failure.
United Therapeutics
Corporation (NASDAQ: UTHR) is also in the PAH
space. In May, United won FDA approval
for Tyvaso DPI(TM) (treprostinil) inhalation powder for the
treatment of pulmonary arterial hypertension (PAH; WHO Group 1) and
pulmonary hypertension associated with interstitial lung disease
(PH-ILD; WHO Group 3) to improve exercise ability. Tyvaso DPI
represents a new formulation and inhalation device for inhaled
treprostinil and is the only dry powder inhaler approved by the FDA
for use in PAH and PH-ILD.
Bristol-Myers Squibb
(NASDAQ: BMY) is in the heart space in many
areas, as exemplified by the company's April
announcement of winning FDA approval for Camzyos(TM)
(mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment
of adults with symptomatic New York Heart Association ("NYHA")
class II-III obstructive hypertrophic cardiomyopathy (obstructive
HCM) to improve functional capacity and symptoms. Camzyos is the
first and only FDA-approved allosteric and reversible inhibitor
selective for cardiac myosin that targets the underlying
pathophysiology of obstructive HCM.
The World Health Organization estimates that about 700 million
people in the world between the ages 30 and 79 have untreated high
blood pressure. A new drug that assumes the role as a standard of
care aside, treating a portion of these people not already on
medications is a massive market opportunity, especially if a drug
can be differentiated from others. Safe to say that with that type
of potential, companies of all sizes are on the lookout to
be the company that brings a new, better drug to
market.
For more information about Lexaria Bioscience
Corp., please visit Lexaria
Bioscience Corp.
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