The new programs come on the heels of a recently-closed oversubscribed financing worth US$11 million
Lexaria Bioscience Corp (NASDAQ:LEXX) () announced a pair of R&D programs Monday focused on DehydraTECH utilizing CBD for hypertension and antivirals to treat COVID-19.
The new programs come on the heels of a recently-closed oversubscribed financing worth US$11 million, which the company said has greatly enhanced its ability to conduct applied R&D designed to test the effectiveness of its patented DehydraTECH drug delivery technology across multiple classes of bioactive substances or drugs.
Lexaria’s prospective business partners expect evidence that demonstrates initial effectiveness of DehydraTECH in improving drug delivery characteristics prior to entering negotiations, the company said. As such, the company considers R&D studies to be a vital early step in establishing relationships with industry partners to utilize DehydraTECH in their product lines.
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Hypertension
Lexaria announced two studies, HYPER-A21-1 and HYPER-A21-2, each of which have completed their initial design phase. Contracts have been entered with the third-party laboratory that will be performing the work, the company said.
Animal dosing is expected to occur in February/March with results in April/May, followed by analysis and reporting. In each study, as many as four different formulations of DehydraTECH-processed CBD will be utilized, including recent enhancements intended to further optimize the delivery of CBD. The tests will measure performance indicators such as rapidity and quantity of delivery to the bloodstream and brain.
Some of the formulations represent generation 2.0 DehydraTECH improvements not yet commercially released, the company said.
Ultimately, the studies are expected to deliver important data to Lexaria in its effort to further support the validity of using DehydraTECH-processed CBD as a potential hypertension treatment. Roughly 1.1 billion people suffer from hypertension around the world, which currently represents a US$28 billion market, the company said.
A 2018 human clinical study found that DehydraTECH-processed CBD lowered human blood pressure while generic CBD did not. Since then, Lexaria has been granted patents in the European Union and Australia to use DehydraTECH-processed CBD to treat heart disease. The company is also planning a second human clinical study in pre- and mild hypertension subjects for 2021.
Antivirals
On December 22, Lexaria announced the commission of two studies to evaluate DehydraTECH’s ability to enhance the delivery and efficacy of four additional antiviral drugs, including remdesivir, a nucleotide reverse transcriptase inhibitor (NtRTI) approved by the US Food and Drug Administration (FDA) in October for the treatment of coronavirus in cases of hospitalization.
The first of these studies, VIRAL-A20-2, has completed its initial design phase, the company said, and the contract has been entered with the third-party laboratory that will be performing the work. Animal dosing is expected in February/March with results in May/June, followed by analysis and reporting. The second study, VIRAL-A20-3, is still in the initial design planning stages.
An additional study, VIRAL-C21-3, will be undertaken to observe the performance of various DehydraTECH-enabled formulations in an established cell culture model of SARS-CoV-2 infected cells in an effort to kill the virus. The contract for the study is in place and design aspects are nearly complete with the third-party lab. VIRAL-C21-3 is expected to begin in March with results in the months to follow.
If that study is successful, Lexaria would expect to subsequently design an in-vivo efficacy program to determine if DehydraTECH-enabled antiviral drug formulations offer performance enhancement when given orally to SARS-CoV-2 infected animals, the company said.
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