- In 2021, Lexaria conducted several main studies evaluating DehydraTECH-processed CBD and nicotine
- The company has big plans for 2022, a year it expects to undertake three ground-breaking studies
- Lexaria hopes these three major studies will generate sufficient data to support either regulated IND-type applications or to stimulate corporate partnerships
- The company is eying larger national and international applications for DehydraTECH with the aim of generating revenue through licensing fees and royalties
For Lexaria Bioscience (NASDAQ: LEXX), a drug delivery company whose patented DehydraTECH(TM) technology has proven effective in improving bioavailability, speed of onset, and efficiency of orally-delivered fat-soluble active molecules and pharmaceuticals, 2021 was a year of myriad milestones. In an annual letter to shareholders, company CEO Chris Bunka underlined that January 2021 marked the birth of a modern version of the company (https://ibn.fm/Djp5l).
“During 2021, we completed research & development (‘R&D’) and validating work equal to or greater than all the combined amount previously completed since 2018! We have conducted studies across broad areas of interest, but also concentrated in specific areas where we have had supportive data,” writes Bunka.
Last year, Lexaria’s most significant area of investigation was DehydraTECH-processed cannabidiol (“CBD”) for the potential treatment of hypertension and heart disease. The company conducted HYPER-H21-1, its first human study of 2021, that showed that human blood pressure (“BP”) decreased within minutes of ingesting a single dose of DehydraTECH-CBD capsules.
Its follow-up study, HYPER-H21-2, in which participants received three doses of DehydraTECH-CBD and were monitored over a 24-hour ambulatory period, showed a 23% average decrease in BP, relative to placebo, among patients with mild to moderate hypertension. Over the 24 hours, the reduction in BP averaged 7.0%. The study also evidenced reduced arterial stiffness among the volunteers.
Encouraged by the findings and building on the same, Lexaria has big plans for 2022. Starting in April or possibly sooner, the company plans to begin dosing in its largest-ever hypertension study. “If this study is successful, we feel strongly that it will be highly supportive of our IND filing plan, and we will have a clear path toward designing of Phase 1 and even potentially Phase II FDA-registered clinical studies thereunder. Assuming there are no major delays either in study execution or evaluation, we expect full results from this study sometime in Q3, 2022,” Bunka adds.
Bunka also expressed the company’s plans to expand its DehydraTECH-CBD program by exploring other development opportunities. Specifically, before this Spring, Lexaria expects to launch a complex animal study to evaluate DehydraTECH-CBD as a potential treatment to inhibit seizure activity in animals. The company has also announced its intention to pursue efficacy modeling through 2022 with its DehydraTECH-CBD in animals for other possible therapeutic indications, namely dementia, rheumatoid diseases, and diabetes.
In addition, 2021 saw the company undertake a nicotine animal study wherein it evidenced that DehydraTECH effectively promoted nicotine delivery characteristics in sublingual/buccal (oral tissue). The study offered yet another opportunity for the company to demonstrate DehydraTECH’s versatility to work effectively in different parts of the body, opening doors to drug delivery through multiple other products.
Based on these successes, Lexaria plans to launch a similar study in humans, expected to “start soon.” Bunka believes that if the company demonstrates a similar performance of nicotine absorption in humans, it will have achieved another significant milestone as it journeys toward the commercial applicability of its technology.
Further, Bunka voices his enthusiasm at 2022, noting: “The goal of our three major studies is to generate sufficient data to support either regulated IND-type applications or to stimulate corporate partnering within their appropriate market sectors. We are optimistic of positive results – noting that science can be unpredictable – and, if so, expect 2022 to be our most exciting year ever!”
In addition, Lexaria strengthened its IP portfolio with the receipt of five new patents in 2021, which brought its total to 23 granted globally. As well, it up-listed to the Nasdaq Capital Markets, where it raised $11 million in gross proceeds budgeted to finance its R&D initiatives and operations.
Bunka also lays stress on the company’s longer-term goals as regards revenue generation. Whereas Lexaria generated its highest-ever revenues in 2021 of over $720,000, mainly due to its DehydraTECH licensing arrangements with its existing clients, the company is primarily focusing on larger national and international applications for DehydraTECH, chiefly but not limited to the pharmaceutical sector. Accordingly, Lexaria is targeting licensing fees, milestone payments as well as royalties.
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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