- Lexaria Bioscience is a global innovator in drug delivery platforms whose patented DehydraTECH(TM) technology has demonstrated the ability to improve the bioavailability and increase the speed of onset of many drugs
- In calendar 2022, the company achieved a number of milestones in various areas, including research programs, receipt of patents, and licensing agreements
- Lexaria started and completed its fourth and most comprehensive hypertension study yet, investigating the capabilities of DehydraTECH-CBD, with the study showing that its formulation resulted in a sustained reduction in blood pressure over the study period (five weeks)
- The company has also started investigating DehydraTECH-CBD as a potential therapeutic for the treatment of dementia and diabetes and is planning to begin another study on DehydraTECH-nicotine pouch performance
- Over the course of the year, Lexaria was granted four new patents, and entered into separate licensing agreements with four new partners
In his concluding remarks in this year’s letter to shareholders published January, Lexaria Bioscience (NASDAQ: LEXX) CEO Chris Bunka underlined that “Management of [the company] feels we are on track, on schedule, and on budget to deliver what we hope and expect will be great results in 2022” (https://ibn.fm/cD2BJ). Since then, the company has achieved crucial milestones that can well be described as “great results,” and rightly so. These milestones are centered around Lexaria’s patented DehydraTECH(TM) drug delivery technology.
DehydraTECH can be applied to many drugs and fat-soluble active pharmaceutical ingredients (“APIs”), with the resultant formulation boasting better speed of onset, bioavailability, and brain absorption. So far, Lexaria has evidenced, through pharmacokinetic (“PK”) studies, that its technology delivers higher quantities of cannabidiol (“CBD”), oral nicotine, and antiviral drugs into the bloodstream in less time, properties that are technically known as increased bioavailability.
For Lexaria, however, the end goal does not only lie in uncovering DehydraTECH’s ability to improve the bioavailability of various APIs. Instead, the company is keen on establishing whether DehydraTECH can be applied broadly within the pharmaceutical industry. And calendar 2022 has brought the company closer to realizing this goal, with the company initiating a slew of research programs, many of which it has already completed. Moreover, its intellectual property (“IP”) portfolio has received additional patent protection in different jurisdictions around the world. Lexaria has also entered into multiple manufacturing and/or licensing agreements with global partners.
Research Programs
DehydraTECH-Processed PDE5 Inhibitor
Lexaria kicked the year off with an announcement of ground-breaking findings in an animal study evaluating DehydraTECH-processed sildenafil, a phosphodiesterase (“PDE5”) inhibitor used in the management of erectile dysfunction. The study, whose results were announced February 2, showed that the DehydraTECH formulation delivered more sildenafil (roughly 70% more drug) and at a faster rate (about 25% faster) than the concentration-matched, generic control formulation (https://ibn.fm/fSxz3).
DehydraTECH-Processed CBD
In 2022, much like in 2021, Lexaria’s biggest area of investigation was CBD – or, more specifically, DehydraTECH-processed CBD. The company expanded the scope of its research to include not only investigations on hypertension or high blood pressure, a condition on which it had completed two human studies (HYPER-H21-1 and HYPER-H21-2) the year prior, but also diabetes, seizures, and dementia.
Building on the HYPER-H21-1 study, a 24-person study that evidenced a rapid and sustained drop in blood pressure, and HYPER-H21-2, which showed that DehydraTECH-CBD caused a 23% average reduction in overnight blood pressure and reduced arterial stiffness, Lexaria also released the findings of its 16-person HYPER-H21-3 study in April this year. This third study evidenced that the pulmonary artery systolic pressure was attenuated by about 5 mmHg or 41% overall in male participants (https://ibn.fm/6DBAM).
The positive findings from the HYPER-H21-3 study set the stage for the commencement of the fourth human clinical study (“HCS”), HYPER-H21-4, the most comprehensive study Lexaria has ever undertaken, that same month (https://ibn.fm/7179M). A 66-person randomized, double-blinded, placebo-controlled, cross-over study, HYPER-H21-4 was designed as a multi-week study whose dosing was completed in July with no serious adverse events reported. That was a vital outcome given that the main objective of most FDA-registered Phase I studies is to prove safety and tolerability.
This news was a precursor to even more positive news reported in late October when Lexaria announced that HYPER-H21-4 “may be the world’s first study to evidence a sustained drop in blood pressure (“BP”) in normally active hypertensive patients following multiple weeks of oral CBD therapy, using Lexaria’s patented DehydraTECH-CBD capsule formulation.”
The study showed a significant BP reduction by 2.5 weeks, with this attenuation sustained over the entire five weeks of dosing. Moreover, Lexaria also observed that the decreases in BP were similar in persons receiving treatment with standard-of-care BP medication as in persons who were not undergoing any current treatment, suggesting DehydraTECH-CBD’s potential abilities to offer additive BP reduction benefits above and beyond the therapeutic improvements of standard BP medication. This can have important regulatory implications.
“That we were able to lower blood pressure in our patient population over multiple weeks using DehydraTECH-CBD is an exceptional discovery, given that previous studies by others using other oral CBD formulations have failed to evidence this sustained benefit,” Chris Bunka commented. “DehydraTECH also demonstrated excellent safety and tolerability results and no adverse changes in liver enzymes throughout the study. Indeed, of the handful of minor, non-serious adverse events reported, there were nearly as many reported by those patients receiving placebo as those who received DehydraTECH-CBD.”
HYPER-H21-4 was designed to enhance Lexaria’s probability of success with its expected Investigational New Drug (“IND”) application to seek the US Food and Drug Administration (“FDA”) approval to begin registered clinical testing. Against the backdrop of the findings from this study, and having already received positive feedback from a pre-IND meeting with the FDA, according to an August press release (https://ibn.fm/OQl3x), Lexaria is on track to file the full IND application in 2023. (Following the pre-IND meeting, the FDA confirmed its support for an abbreviated approval pathway in line with section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.)
Meanwhile, in a separate three-part animal study that kicked off in March that aimed to assess the effectiveness of DehydraTECH-CBD in reducing seizure activity compared to the FDA-approved seizure medication Epidiolex (https://ibn.fm/X6zl1), Lexaria evidenced that DehydraTECH-CBD can be more efficacious at lower doses than Epidiolex. Additionally, the company observed that DehydraTECH-CBD can act more rapidly than Epidiolex. According to Lexaria, work is ongoing to complete the third and final part of the study that intends to establish the dose required to achieve seizure inhibition in 50% of the animals tested or ED50 (https://ibn.fm/hOsRb).
In addition to the hypertension and seizure studies, Lexaria recently commenced separate investigations on the potential therapeutic use of DehydraTECH-CBD in both diabetes and dementia. Dubbed DIAB-A22-1, the study investigating DehydraTECH-CBD’s potential utility in the treatment of diabetes kicked off on November 8 (https://ibn.fm/V45Lm), while DEM-A22-1, the study on the potential use of DehydraTECH-CBD in dementia, begun a couple of days later on November 10 (https://ibn.fm/xp2mS).
DehydraTECH-Processed Nicotine
Calendar 2022 also marked the year when Lexaria began expanding its research on nicotine to include human subjects. Having resolved the manufacturing and logistics challenges that had previously pushed back the commencement time as well as having received Independent Review Board (“IRB”) approval for the planned human oral nicotine study, NIC-H22-1, Lexaria expects to begin dosing in December 2022 (https://ibn.fm/6L0fJ).
A 36-person human PK, randomized, double-blinded, cross-over-study carried out in current cigarette smokers, NIC-H22-1 will see each participant receiving only one brand of oral nicotine pouch on each of the three visits to the laboratory over a period of weeks. Upon administration, each person will undergo both subjective and objective evaluations, with vital signs such as respiratory rate, heart rate, blood pressure, and temperature also collected. Overall, the study is specifically designed to compare the performance of Lexaria’s DehydraTECH-nicotine pouch to On!’s (a pouch brand manufactured by Altria) and Zyn’s (the world’s leading nicotine pouch product manufactured by Swedish Match).
Competition in the nicotine pouch category is heating up, with PMI have just completed its US$16 billion acquisition of Swedish Match.
Previously, Lexaria had demonstrated in animal study NIC-A21-1 that oral nicotine pouches processed using DehydraTECH were 10 to 20 times faster in reaching peak delivery of nicotine to the bloodstream than controls.
Patents
In 2022, Lexaria continued to strengthen its intellectual property portfolio, receiving four new patents as described below:
- In March, Australia granted Lexaria a patent entitled “Compositions Infused with Nicotine Compounds and Methods to Use Thereof” that covers most oral forms of nicotine, including sprays, gums, pouches, capsules, lozenges, tablets, and pills. The patent also covers various forms of nicotine, including free base nicotine, polymer resins of nicotine, nicotine salts, and other forms of nicotine complexes (https://ibn.fm/o9j34).
- In April, the United States Patents and Trademark Office (“USPTO”) granted Lexaria its first-ever patent for using DehydraTECH technology to enhance the delivery of antiviral drugs (https://ibn.fm/GVR4X).
- In July, Lexaria received its fourth patent granted in Japan, entitled “Lipophilic Active Agent Infused Compositions with Reduced Food Effect,” which acknowledges the ability of DehydraTECH to deliver APIs more effectively regardless of the presence of foods within the gastrointestinal system (https://ibn.fm/B7VuC).
- In August Lexaria received a new patent in Mexico that covers multiple claims, including but not limited to the treatment of hypertension, neurological diseases, diabetes, hepatic diseases, and more (https://ibn.fm/7RM1Q).
With the receipt of the four patents in 2022, Lexaria now has 27 worldwide patents granted, with about 50 more patents pending worldwide. The company believes that should the remaining patent applications become granted patents, its ability to generate meaningful license revenue from its IP may increase from multiple other countries and regions outside of the United States. And if this year’s licensing agreements are anything to go by, Lexaria is progressively inching closer to this goal, one partner at a time.
Licensing Agreements
Generally, the company’s granted patents help to buttress a part of the company’s business plan, which according to its latest annual report, is to “encourage new and existing participants to license and utilize DehydraTECH to enable enhanced performance of their products” (https://ibn.fm/FzUTU). To that end, this calendar year saw the company onboard new partners who have licensed the DehydraTECH technology for use in their respective markets. Anchored in licensing agreements announced in June, the licenses include:
- A European and United Kingdom DehydraTECH license for medical cannabis applications from wholly owned subsidiary Lexaria Pharmaceutical Corp. to Valcon Medical A/S, a European contract manufacturing organization (“CMO”) that manufactures medical cannabis extracts for the European Union (“EU”) and the UK (https://ibn.fm/ciTUJ)
- An exclusive commercial licensing agreement granted to Premier Wellness Science Co. Ltd. for the Japanese non-pharmaceutical market for the use of DehydraTECH with CBD and hemp ingredients in oral liquid and non-liquid products, topical, hair, lip-care, and cosmetics products (https://ibn.fm/0f8D0)
- A five-year, non-exclusive DehydraTECH license to AnodGen Bioceuticals of Ireland, a CMO, for the manufacturing and distribution of DehydraTECH-processed cannabinoid API powders within Europe, Australia, and New Zealand (https://ibn.fm/FjMBZ)
- Two agreements – a manufacturing operating agreement and a commercial license agreement – with Atlanta-based BevNology LLC. (https://ibn.fm/vEY4J)
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://ibn.fm/LEXX
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