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New York, NY – August 10, 2022 – 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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