Lexaria Bioscience: Charting a Path to Commercial Success
Lexaria Bioscience (Nasdaq: LEXX), is charting a path to commercial success with its proprietary drug delivery technology, DehydraTECH™. The company closed out a year of milestone achievements with positive results from its human hypertension study, positioning Lexaria strongly as it pursues FDA registration of DehydraTECH-CBD.
DehydraTECH – a potential game changer for a number of different markets – improves the way active pharmaceutical ingredients enter the bloodstream, increasing bio-absorption by up to 10x, reducing time of onset from hours to just minutes and masking unwanted tastes.
We took a closer look at the advancements Lexaria has made in its commercialization strategy during 2022.
Cannabidiol (CBD): On Track for FDA Approval
2022 established Lexaria as one of the world’s leaders in the investigation of CBD for the purposes of controlling human blood pressure. The company’s top priority for the year was to develop its DehydraTECH-CBD hypertension program, according to company CEO, Chris Bunka, who described the year’s efforts as an “unqualified success”.
Lexaria evidenced that its DehydraTECH-CBD offers advanced CBD delivery performance, including apparent significant brain perfusion capabilities, enabling enhanced pharmacological effectiveness at lower doses.
The company’s human clinical study reported exceptional safety and tolerability, statistically significant lowering of 24-hour ambulatory blood pressure and lowered blood pressure for the five-week study duration. Importantly, no adverse changes were observed in patient liver enzymes; an important clinical safety biomarker of oral CBD therapy.
Lexaria expects to launch its FDA-registered IND program to formally investigate DehydraTECH-CBD for hypertension in 2023.
Nicotine: Clinical and Commercial Progress
Lexaria has the opportunity to potentially disrupt the oral nicotine pouch category, one of the fastest growing segments in the nicotine industry due to the reduced risk of health outcomes. The global market for oral nicotine pouches is projected to reach nearly $22 billion by 2027.
In December, 2022, Lexaria commenced dosing in a 36-person randomized, double blinded crossover study comparing DehydraTECH-nicotine oral pouch performance to currently sold brands, ON! and Zyn. The company expects to demonstrate that DehydraTECH-nicotine delivers better oral-tissue absorption and fewer negative experiences.
During the year, Lexaria announced it had entered a new agreement with tobacco corporation, Altria, where Lexaria received a fee as part of a nicotine formulation creation and evaluation program. In 2022, Lexaria was also granted its first patent from its 8th patent family in Australia, expanding upon Lexaria’s international intellectual property rights to apply DehydraTECH enhancement technology to most oral forms of nicotine, including pills, tablets, lozenges, capsules, pouches, gums and sprays. The company believes this patent could potentially lead to significant competitive advantages.
DehydraTECH-CBD for Seizures
Lexaria’s 2022 animal seizure study demonstrated that DehydraTECH-CBD is more effective than Epidiolex® at reducing and eliminating seizure activity at lower doses. Epidiolex is the only FDA-approved CBD anti-seizure drug and the only CBD drug indicated for seizures in the world. Lexaria has also noted that Epidiolex’s marketing exclusivity is nearing expiration.
Following the success of its seizure investigation program, Lexaria has stated the program will be one of its highest priorities in 2023 due to its potential to support important industry relationships that may be transformative for the company.
The DehydraTECH platform has wide applicability across a range of indications. Lexaria has begun investigations into its utility against dementia and diabetes, both of which have strong links to hypertension. Hypertensive patients are at greater risk of developing diabetes, and people who have diabetes are twice as likely to suffer from hypertension. Similarly, high blood pressure is a key risk factor in developing vascular dementia. The company expects to complete dosing in its animal diabetes study and its animal dementia study in Q1 2023.
Increased Institutional Ownership
During 2022, Lexaria saw an increase in institutional ownership of its stock as well as an uptick in biotech analysts and investors conducting serious due diligence on the company. Lexaria’s institutional ownership reached its highest point for the year in November 2022, at 11.6%, with Mr. Bunka describing the rise as a sign of “smart money” moving into Lexaria’s stock.
Building a Winning Team
Lexaria’s management team is made up of executives, directors, and advisors with deep drug delivery technology, capital markets expertise and strong industry relationships. The company recently appointed the former President of GW Pharmaceuticals USA, Mr. Julian Gangolli, as a strategic advisor as it positions itself as a world leader in the CBD space. Mr. Gangolli oversaw FDA approval of the first and only pure CBD drug ever approved by the FDA, Epidiolex®, and its subsequent successful commercialization in the USA.
Lexaria is looking towards 2023 with optimism, with the prospect of another strong year ahead. In the first quarter, the company expects to complete dosing in two animal studies and its human nicotine study, and anticipates additional results from its human hypertension study. Lexaria has indicated it will file its IND application and expects to receive FDA approval to commence its IND program.
As it works towards becoming a true pharmaceutical company, Lexaria is paving the way for additional commercial pursuits of its DehydraTECH-CBD for therapeutic use, while setting the stage to reach one or more commercial agreements within the pharmaceutical industry.