To gain insight into the challenges facing the pharmaceutical sector and how new technology can offer solutions, Digital Journal caught up with John Docherty, President of Lexaria Bioscience. Docherty is well-equipped to look at the topic, building up over 20 years of experience in the pharmaceutical and biopharmaceutical sectors. This includes working with large multinational companies, as well as emerging private and publicly-traded start-ups.
Docherty’s expertise in investor and stakeholder relations, capital raising, capital markets development, and strategic partnering has translated to a deep understanding of the regulatory issues affecting drug design and development.
Digital Journal: Can you give me an introduction to Lexaria Bioscience and your role?
John Docherty: Lexaria Bioscience Corp. is a global innovator in drug delivery platforms. Its patented DehydraTECH™ drug delivery technology changes the way Active Pharmaceutical Ingredients enter the bloodstream following oral intake, promoting enhanced safety and effectiveness for fat soluble or “lipophilic” active molecules.
DehydraTECH increases bio-absorption, reduces time of onset, and masks unwanted tastes for orally administered lipophilic drugs. DehydraTECH has been assessed with a range of compounds including cannabinoids, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs, e.g. ibuprofen), nicotine and other molecules, and is covered by 16 issued and over 60 patents pending worldwide.
At Lexaria, my primary responsibility is leading R&D and commercialization of the Company’s DehydraTECH technology. I have been a senior executive in the pharmaceutical and bioscience sectors for over 20 years. I am a toxicologist and pharmacologist by training with an emphasis on the development of advanced drug delivery technologies, and a named inventor on multiple issued and pending patents.
DJ: What are some industries Lexaria works in?
Docherty: Lexaria has licensed DehydraTECH to multiple companies that include a world-leading tobacco producer for the development of smokeless, oral-based nicotine products and numerous players in the hemp/cannabis industry for use in cannabinoid beverages, edibles and oral products. Most recently, Lexaria announced its foray additionally into the pharmaceutical sector, beginning with plans to test its DehydraTECH during 2020 as a means to improve the bioavailability of oral antiviral drugs for treatment of COVID-19 and other infectious diseases.
DJ: How does Lexaria’s drug delivery technology work?
Docherty:DehydraTECH has been shown to enhance the bioavailability and performance of lipophilic beneficial compounds in oral ingestible products. DehydraTECH is designed to effect a molecular association between a given active ingredient of interest and long chain fatty acids such as oleic acid together with certain emulsifier compounds. It does this in order that intestinal biliary mechanisms governing fatty acid absorption and lymphatic channeling are conferred upon the associated active ingredient essentially as a “payload” molecule for enhanced bioabsorption and systemic uptake. DehydraTECH formulations are rendered by way of an elegant and cost-effective multi-step process that combines the active ingredient, fatty acid and emulsifier compounds through a dehydration processing reaction in order to effectuate their molecular interaction.
DehydraTECH formulations have been prepared with a range of lipophilic molecules of interest and administered orally to animals and/or humans to investigate pharmacokinetic and pharmacodynamic performance attributes. For example, in young healthy humans, as published in 2019 in the medical journal Advances in Therapy, the DehydraTECH technology has been studied in an oral CBD formulation and shown to result in statistically significantly higher and more rapid levels of delivery to the bloodstream than concentration matched controls, together with a powerful effect at lowering blood pressure.
DJ: How is Lexaria contributing to further advance the fight against COVID-19?
Docherty:The world was caught by surprise upon the emergence of the novel coronavirus, in response to which scientists worldwide began a global effort to determine if any existing antiviral drugs for other conditions may be able to combat it. These so called “repurposed” drugs that have shown promise have included drugs like remdesivir, lopinavir, ritonavir and ribavirin among others, evaluated alone and in combination treatment regimens.
Based on Lexaria’s success to date in developing and commercializing DehydraTECH oral product formats for other lipophilic drug compounds, it is actively investigating its prospective utility to improve the bioavailability and, in turn, the safety and efficacy of certain antiviral drugs as candidate treatments for COVID-19 and other infectious diseases. Studies are planned to include pilot testing in human volunteers to determine the rate and extent of bioavailability enhancement for certain repurposed antiviral medications upon oral administration, as well as testing that will evaluate if this translates into increased effectiveness against SARS-CoV-2 and/or other infections in appropriate laboratory and animal models. If successful, the Company intends to make its DehydraTECH technology available to prospective research partners, pursuant to its technology out-licensing business model, who are looking to maximize the effectiveness of their existing and emerging antiviral drugs.
DJ: What is the value of getting the drug delivery mechanism right for COVID-19?
Docherty:While a host of antiviral drugs exist or are under development today, many of them are hindered by poor water solubility which, in turn, results in their poor absorption and uptake by the body if taken orally. This, in turn, interferes with how well they can reach the bloodstream after ingestion and frequently limits their overall therapeutic effectiveness if administered via the oral route.
To attempt to overcome this, oral antiviral medications often have to be given at high doses which can result in a variety of unwanted side effects including diarrhea, headache, nausea, vomiting, stomach upset, drowsiness, dizziness, vision changes, difficulty breathing and other bodily dysfunctions.
Alternatively, in some cases it is necessary to administer antiviral medications by way of needle injection for easier access to the bloodstream circumventing the gastrointestinal absorption limitations. Remdesivir, as mentioned above, is one such example of an antiviral medication administered by injection instead of orally for this reason. However, injectable administration requires involvement of a medical practitioner which may not always be easily accessible for the masses, usually increases cost of a medicine and often means that the product format isn’t as stable or requires special storage and handling considerations relative to oral medications.
Lexaria, therefore, believes that there is potentially tremendous value in not only enhancing the safety and effectiveness of oral antiviral drugs for COVID-19 and other infectious diseases using its DehydraTECH technology, but, also in thereby improving the utility and availability of the oral route of administration over injection for wider and easier access to patients worldwide.
DJ: What do you think is the future of drug delivery technology?
Docherty:We are increasingly seeing researchers around the globe investigating ways of improving drug targeting at specific sites in the human body where diseases manifest. The value of this, of course, is to improve therapeutic effectiveness while minimizing drug action upon non-target tissues in order to lessen unwanted side effects. In my view, the future will increasingly involve development of these “smart” drugs to be formulated in concert with delivery systems such as DehydraTECH in order to ensure precise targeting together with enhanced and rapid absorption and systemic uptake upon administration.
7. Is there anything you’d like to add/cover?
Only that I would like to note that while Lexaria is principally focused in the area of enabling enhanced oral drug delivery, it has also demonstrated utility of its DehydraTECH technology in increasing dermal and transdermal drug delivery when applied to topically formulated drug products. This represents another area of interest to Lexaria and one in which it is actively seeking and working with prospective research and commercialization partners for above and beyond its oral drug delivery initiatives.
