EXECUTIVE INTERVIEW - Lexaria Bioscience Corp.: Stretching Its Legs

Lexaria Bioscience Corp. is a publicly traded biotechnology company focused on the development and commercialization of its patented DehydraTECH^TM drug delivery platform technology. Lexaria’s technology is mainly designed for improving the systemic absorption of orally administered lipophilic compounds, although it has also been shown to be effective in enhancing systemic delivery through the topical administration route. Lexaria began developing its DehydraTECH technology in 2014 and has since demonstrated its applicability and utility across a broad range of lipophilic drugs and beneficial compounds. Lexaria has grown significantly over this time with a state-of-the art, Health Canada-licensed formulation laboratory in Kelowna, British Columbia, as well as contract formulation and/or production laboratories operating in Salt Lake City, UT, and Atlanta, GA. DehydraTECH technology is currently protected by 18 issued patents spanning the US, Europe, and Australia, with roughly 60 additional patent applications pending worldwide. Drug Development & Delivery recently spoke with John Docherty, President of Lexaria, to learn more about how the company’s recent uplist to the NASDAQ has resulted in its largest capital injection to date, which will allow it to focus on preclinical and clinical testing programs for DehydraTECH formulations across three main areas of interest: cannabidiol for treatment of hypertension; antiviral drugs for treatment of COVID-19 and other infectious diseases; and reduced risk oral nicotine products for CPG and/or pharmaceutical purposes.

Q: Can you describe the pain point you see in pharma and how DehydraTECH addresses that challenge?

 A: By enhancing the oral deliverability of lipophilic drugs and beneficial molecules, Lexaria’s DehydraTECH can address important medical and market needs for the pharma industry across three key areas. First, the technology enhances effectiveness whereby DehydraTECH formulations have been shown to significantly increase speed and quantity of absorption into both the bloodstream and even brain tissues thereafter for certain CNS-active agents. Second, it can improve tolerability whereby DehydraTECH’s ability to enhance effectiveness can, in turn, often allow reduced dosing for any given effect profile, thereby mitigating unwanted side effects. Finally, there is a potential to expand ease of access and breadth of distribution in cases where lipophilic drugs are currently only available in injectable formats that could possibly be transitioned to effective oral formats using DehydraTECH. All three of these potential pharma benefits are, for instance, top of mind priorities for Lexaria in its present pursuit of safer and more effective oral antiviral therapies for certain COVID-19 therapies that are only available today in injectable form.

Q: Can you expand on how DehydraTECH works to enhance absorption and oral delivery, and how delivery is enhanced across the GI barrier and within brain tissue?

 A: Lexaria’s patented DehydraTECH formulation and processing methodology involves combining a lipophilic active ingredient with certain types of fatty acids – mainly long chain fatty acids (LCFA) – at a molecular level by way of a dehydration technique that it has developed. DehydraTECH formulations are rendered as highly stable powders that can then be integrated into a wide variety of solid oral dosage forms or even food products, or additional processing steps can be employed to integrate these powders into oral consumable liquids and topically administered form factors as well. Once administered, DehydraTECH formulations enable enhanced systemic delivery of their active ingredient “payloads” because of the emollient properties of their fatty acid compositions for enhanced permeation of epithelial/mucosal tissues and, most notably, upon intestinal exposure because they work in concert with biliary functionality that naturally promotes rapid lymphatic uptake of LCFA-containing materials. DehydraTECH formulations have also been shown to lead to enhanced blood-brain-barrier permeability, which Lexaria believes is due to fatty acid transport proteins that are found throughout the vasculature of the brain and naturally facilitate uptake of LCFA-containing materials.

Q: How is Lexaria taking DehyraTECH from the CPG space to the pharma space.

 A: Lexaria’s early work beginning in 2014 and 2015 was focused almost entirely on applications of DehydraTECH for the cannabinoid CPG sector, whereby it demonstrated proof-of-principle in vitro, in vivo animal, and human data with molecules such as cannabidiol, and out-licensed its technology to multiple players in the space. Following this, Lexaria began to explore applicability of its technology to more highly regulated CPG product applications, such as the nicotine product sector, for which it issued a non-exclusive worldwide license to Altria in 2019 and entered into an R&D collaboration with British American Tobacco during 2020. Most recently, in late 2020 and early 2021, Lexaria has begun to focus on the pharma space as it is pursuing expanded programs testing DehydraTECH-CBD formulations for hypertension therapy and DehydraTECH-antiviral formulations for COVID-19 and other infectious disease applications. Lexaria believes the greatest commercial opportunities and potential for its DehydraTECH technology lie in the pharma space for these and a multitude of other therapeutic applications. This is not dissimilar to the way that GW Pharmaceuticals took what was effectively a generic version of CBD and accomplished the admirable achievement of getting it approved for use to treat certain seizure disorders, eventually leading to a multi-billion corporate transaction.

Q: Digging a bit deeper, can you share some of the study data that shows how DehydraTECH improves drug delivery of antiviral therapies, such as Remdesivir?

 A: Lexaria recently announced findings from an animal study that demonstrated that its DehydraTECH technology significantly enhanced systemic drug delivery of representative drugs from two classes of antivirals actively under investigation today for COVID-19. These included a protease inhibitor (darunavir; 54% increase in AUC∞; p=0.036) and a reverse transcriptase inhibitor (efavirenz; 42% increase in AUC∞; p=0.028). Based on these findings, the company is actively pursuing a further round of animal testing to determine if DehydraTECH can similarly enhance the delivery of Remdesivir as another type of reverse transcriptase inhibitor actively in use for COVID-19 treatment today; specifically, a nucleotide reverse transcriptase inhibitor (NtRTI). In parallel, Lexaria is going to perform work to assess the relative antiviral activity of DehydraTECH antiviral formulations in an established cell culture model of SARS-CoV-2-infected cells, with a view to expanded efficacy testing thereafter in SARS-CoV-2-infected animals.

Q: How can DeydraTECH benefit other injectables, and what does this mean for COVID-19 treatment?

A: If Lexaria’s upcoming and planned in vitro and in vivo animal PK/PD testing with DehydraTECH-powered antiviral formulations, including Remdesivir, prove successful, this could lead to broad applicability potential for a host of different lipophilic antiviral drugs for safer and more effective oral formulations for a variety of prospective indications, including COVID-19 treatment. Of course, any positive findings from Lexaria’s upcoming and planned work described here would need to be subjected to further extensive characterization and testing in humans to determine if animal findings translate to man safely and effectively before commercial prospects could be determined.

Q: How large of a market is the antiviral therapy sector?

A: Pending the successful outcome of Lexaria’s upcoming and planned proof-of-principle antiviral formulation and testing studies, it envisions seeking out opportunities to engage with developers of leading antiviral therapeutics for COVID-19 and other infectious disease conditions. Companies like Gilead would be a logical target for this outreach, given its work on the class-leading Remdesivir therapeutic that has received emergency use authorization by regulators around the world, but is currently limited to injectable administration. Remdesivir alone has been predicted to reach $4.2 billion in sales for treatment of COVID-19 and other infectious diseases by 2023.¹

Q: Beyond the aforementioned applications, how will Lexaria advance the development of DehydraTECH formulations?

A: While our immediate focus through early-to-mid 2021 is going to be in advancing development of our DehydraTECH-powered formulations for hypertension, antiviral, and reduced-risk nicotine applications, Lexaria is stretching its legs to see where it can take DehydraTECH. We are very interested in exploring a range of other bioactive substances of interest to the company, spanning NSAIDs, PDE5 inhibitors, estrogen, vitamin D3, and pharmacokinetic evaluations with certain minor cannabinoids. We believe that DehydraTECH formulations across each of these molecule classes and others could represent additional significant opportunities for the company, pending successful proof-of-principle testing and subject to our out-licensing business model, if strategic partner interest is as high as we expect.

Q: What is Lexaria’s out-licensing business model?

A: Lexaria has a successful track record of conducting proof-of-principle development programs using its DehydraTECH technology and effecting licensing arrangements with consumer-facing companies. Lexaria is focused on commercializing its DehydraTECH technology through out-licensing arrangements with third-party pharmaceutical and CPG industry partners. Lexaria already has established relationships with companies in the nicotine CPG sector, including a license arrangement in place with Altria, and an R&D collaboration actively underway with BAT (British American Tobacco). Lexaria similarly intends to seek out relationships with market leaders in its other product pipeline focus areas as its ongoing proof-of-principle development programs advance. Lexaria also routinely is contacted by third parties with interest in exploring DehydraTECH applicability across other molecule classes, whereby it often performs formulation development work on a fee-for-service basis and can offer commercial-scale DehydraTECH formulation capabilities to CPG companies via its contract partner facility in Salt Lake City.

Q: How does Lexaria work with companies that are looking to improve the delivery of their drug molecules?

A: In cases where companies approach us interested to determine if DehydraTECH can improve delivery of their specific drug molecules, we typically enter into mutual due diligence discussions under NDA, followed by bench-scale, non-GMP formulation development and QC testing work in order to render demonstration materials for the companies to receive and evaluate. This work is generally conducted under the framework of a letter of intent agreement between the parties, with a view to prospective DehydraTECH licensing and full technology transfer if the party is satisfied with the outcome of their evaluation testing work upon the demonstration materials furnished. In some cases, we do also have the ability to offer commercial-scale DehydraTECH formulation capabilities to CPG companies via our contract partner facility in Utah, in the event companies do not have these capabilities in house and/or do not wish to become licensees; instead preferring to simply purchase DehydraTECH batch materials on a purchase order fee-for-service basis from us, as needed.

Q: What does uplisting to NASDAQ mean for Lexaria?

A: Lexaria was delighted to complete its NASDAQ uplisting and a concurrent, oversubscribed $11 million institutional financing in January of this year. This signified a major validation of the company and its development programs, and has provided its largest capital injection to date in order to aggressively pursue its technology and formulation development plans. Graduating to a senior US National Exchange gives the company a solid footing to access the widest possible investor and capital base going forward as it continues to grow and evolve in the years to come.

Reference

1. Remdesivir Global Market Report 2020-30: COVID 19 Growth and Change, Reportlinker, July 2020, https://www.reportlinker.com/p05933761/Remdesivir-Global-Market-Report-30-COVID-19-Growth-and-Change.html?utm_source=PRN#backAction=1.