Lexaria's R&D Program Reveals 5 Exciting Results Within 2 Months

The following post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga.

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Biotech company Lexaria Bioscience Corp. LEXX has been making news for DehydraTECH™ — its proprietary disruptive and cost-effective drug delivery technology platform.

Lexaria’s DehydraTECH™ improves how active pharmaceutical ingredients enter the bloodstream. The technology promotes healthier administration methods, lower overall dosing, and higher effectiveness of ingestible drugs and other beneficial molecules.

The company is investigating applications of DehydraTECH-processed formulations for multiple multibillion-dollar markets in several research and development (R&D) programs.

In June and July 2021, Lexaria revealed some impressive results for its applied R&D programs.

1. DehydraTECH™-Enabled Remdesivir and Ebastine to Effectively Inhibit the COVID-19 SARS-CoV-2 Virus

Lexaria’s preliminary findings showed evidence that its DehydraTECH™ formulation and processing methodology did not negate the known antiviral efficacy of remdesevir and ebastine. With these findings, Lexaria will proceed to larger, planned in vivo efficacy testing.

This was an essential step toward advancing to animal and ultimately human efficacy testing to use DehydraTECH-processed drugs to treat COVID-19.

Remdesivir and ebastine have each shown promise in the fight against COVID-19 in many parts of the world. But, both the antiviral drugs have poor aqueous solubility and compromised intestinal absorption and bioavailability when administered orally.

Lexaria hopes that its patented DehydraTECH™ delivery technology will pave the way for better performing oral dosage forms of these and other antiviral drugs.

The study (VIRAL-C21-3) used one of the most widely applied and informative predictive measures of drug efficacy to measure the half-maximal inhibitory concentration (“IC50”) of the drugs when formulated with DehydraTECH™.

Lexaria's antiviral study program may also have benefits beyond COVID-19, including a wide range of other viral disease indications where improved oral delivery performance is needed. The combined market for antiviral drugs is projected to be over $66.7 billion by 2025.

2. Three-Fold Increase in Oral Delivery

The company saw positive results in its tolerability and pharmacokinetic (PK) animal study called VIRAL-A20-2 while evaluating DehydraTECH™-enabled remdesivir and ebastine.

Lexaria CEO Chris Bunka described the findings as the best results the company has ever generated as it demonstrates the technology’s ability to effectively deliver antiviral drugs when taken orally.

The gains in delivery for remdesivir and ebastine exceed those that Lexaria previously reported on December 1, 2020, for darunavir (82% gain) and efavirenz (204% gain). These are 2 other antiviral drugs investigated by Lexaria that are under investigation against COVID-19 and are already in use against HIV.

The company is starting to see circulating drug levels in the bloodstream that are almost 3 times higher with DehydraTECH™ than without, which could significantly enhance opportunities to treat viral infections with oral drug delivery.

3. First Human Clinical Study for Hypertension Relief Completed Ahead of Schedule

Lexaria completed the treatment and dosing in its first human clinical study (HYPER-H21-1) ahead of schedule.

HYPER-H21-1 focused on testing DehydraTECH™-enabled cannabidiol (CBD) for potential use as a hypertension treatment alternative.

The study dosed 24 human volunteers with documented pre-hypertension or mild hypertension aged 45 to 65, all of whom tolerated treatment well with no serious adverse events or side effects observed or reported.

Results are pending both for the blood pressure results themselves, but also for various types of bloodwork analysis that could be very impactful both to this study and to additional ongoing investigations.

4. Successful Antiviral Drug Molecular Characterization Study

Lexaria completed a molecular characterization study (VIRAL-MC21-1) testing all formulations from studies VIRAL-A20-2 and VIRAL-A20-3, carried out by the National Research Council (NRC), Canada’s premier federally funded research organization.

The results confirmed that Lexaria’s study objectives, demonstrating that DehydraTECH™ processing and formulation technology does not create a covalently bonded new molecular entity (“NME”) and that each drug tested remained stable and did not undergo a change in chemical structure.

These findings are strongly supportive of accelerated regulatory filings such as the 505(b)(2) pathway permitted by the Food and Drug Administration (FDA) and other international regulators. By comparison, NMEs are generally subjected to more involved regulatory examination and approval processes than non-NMEs.

5. Successful Results in Tolerability and PK Study on Animals for Colchicine

The study VIRAL-A20-3 demonstrated that DehydraTECH-enabled colchicine, the latest of several drugs that Lexaria has successfully tested with known SARS-CoV-2 antiviral properties, benefited from their proprietary formulation and processing, resulting in increased delivery

Colchicine is an approved therapeutic with anti-inflammatory effects that are primarily used to treat gout and conditions such as cardiac inflammation, and also has potent effects in mitigating the cytokine storm associated with COVID-19.

Colchicine is also known to have a narrow therapeutic index. This means the distinction between toxic and non-toxic doses is marginal and there could be significant benefits in allowing its dosing to be reduced while maintaining therapeutic delivery levels.

Oral colchicine in its available forms today exhibits diminished bioavailability in humans (about 45%). Lexaria believes it can improve upon for better safety and efficacy outcomes.

What’s Next for Lexaria?

Lexaria met all the objectives thus far in its 2021 antiviral drug examination program. The company has announced many developments that are actively underway. Here are some things that are in the pipeline:

• Plans to pursue expanded in-vivo PK and efficacy testing in larger animal populations using the best-performing antiviral drugs from these current investigations to achieve statistical powering of its findings when necessary
• Results from its first human clinical study of 2021, HYPER-H21-1
• Progress of its second human clinical study of 2021, HYPER-H21-2

To learn more about Lexaria, visit its website here.

The preceding post was written and/or published as a collaboration between Benzinga’s in-house sponsored content team and a financial partner of Benzinga. Although the piece is not and should not be construed as editorial content, the sponsored content team works to ensure that any and all information contained within is true and accurate to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.