- Lexaria announced significant strides in six of its studies within the 2021 applied R&D program1
- All the studies are based on Lexaria’s DehydraTECH(TM) technology and are designed for multiple market applications, including oral nicotine, NSAIDs, antivirals, and hypertension
- The 2021 applied R&D program is intended to generate not only confirmatory results and data evidencing but also foster strategic commercial opportunities and corporate relationships
Lexaria Bioscience (NASDAQ: LEXX) (CSE: LXX) released a status report on six of its studies in the 2021 applied research and development (“R&D”) program. The program mainly involves studies using DehydraTECH(TM) 2.0 formulations, with different market areas of applications including oral nicotine, NSAIDs, antivirals, and hypertension.
The announcement marks a significant milestone for Lexaria’s R&D program, and in an official statement announcing the status report, Lexaria also noted that the other ongoing studies would be reported separately (https://nnw.fm/hP8UF). This comes after it announced a status report on two antiviral drug studies in the applied R&D program (https://nnw.fm/llMxS).
The six programs covered in this announcement included:
- HYPER-A21-1 and HYPER-A21-2
- NSAID-A21-1, and
- Oral Nicotine: NIC-C21-1 (Now NIC-A21-1)
A tolerability and pharmacokinetic or (“PK”) study in animals using antiviral drugs.
The program involved four groups of 10 animals, each dosed to determine if DehydraTECH-enhanced remdesivir and ebastine are well tolerated by the subjects and is evaluating peak concentration and total drug delivery into the bloodstream in comparison to non-enhanced controls, as is the case for other antiviral drugs.
An additional tolerability and PK study in animals evaluating Area Under the Curve for three other antiviral drugs. Lexaria reported that all animal dosing and in-life procedures were completed, with sample analysis still ongoing, with a view to reporting soon.
The study involved six groups of 10 animals. It is examining tolerability and quantity of drug delivery for three other antiviral drugs of interest that showed promise in their usage against the COVID-19 SARS-CoV-2 virus. Lexaria indicated that the study is projected to generate reportable results either in July or August.
This study being performed by Canada’s National Research Council is exploring Nuclear Magnetic Resonance (“NMR”) and Liquid Chromatography-High Resolution Mass Spectrometry (“LC-HRMS”) and their application on 5 DehydraTECH-enhanced antiviral drug formulations already being studied under VIRAL-A20-2 and VIRAL-A20-3.
VIRAL-MC21-1 recognizes how important molecular characterization is as a step towards determining whether the DehydraTECH technology alters the underlying drugs significantly enough to yield covalently-bonded new molecular entities (“NMEs”). These NMEs are usually subjected to stringent regulatory examination and approval processes than their non-NME alternatives.
In previous studies, Lexaria has reported that NME formation did not occur following DehydraTECH formulation with other substances of interest, mainly cannabidiol (“CBD”) and nicotine. The results from this project are expected to be reported ahead of schedule. The company is targeting the announcement for the first half of July.
Hyper-A21-1 and Hyper-A21-2
This study followed blood pressure testing in animals, building on previously reported successful PK study findings. It demonstrated statistically significant gains in CBD absorption relative to controls using Lexaria’s latest DehydraTECH 2.0 formulation innovations, according to results released back on May 6 (https://nnw.fm/DlwsI) and 20, 2021 (https://nnw.fm/9CjPI). The study still requires some work, and the testing laboratory responsible for the initial research has been engaged for these follow-up tests. They will involve monitoring real-time animal blood pressure in response to specific formulations from the PK evaluations.
Lexaria hopes that the work will complement previous human clinical study findings that showed a reduction in blood pressure following the use of DehydraTECH-CBD. Animal dosing and in-life procedures are yet to commence but will be reported as soon as there are significant developments in the study.
This research is exploring the tolerability and PK study in animals, with a focus on ibuprofen and naproxen. Test articles were manufactured back in April, as scheduled, with subsequent contracts executed in early May involving animal testing laboratory performing the work. The initial animal dosing started on the week of May 17, ahead of schedule.
The project is currently underway with a focus on pilot tolerability evaluations in rodents. The goal is to determine dosing that shows superior gastrointestinal tolerability, pitting Lexaria’s DehydraTECH test articles against concentration-matched controls.
Pending a successful outcome of the pilot tolerability investigation, formal pharmacokinetic testing will follow. Updates will be provided as soon as there are significant developments in the study.
Oral Nicotine: NIC-C21-1 (now NIC-A21-1)
This is a tolerability and PK study among animals evaluating oral nicotine. It was renamed following the move from an in vitro cell based study to an in vivo study in live anesthetized animals. This move allows Lexaria to conduct a superior evaluation of the systemic absorption of nicotine upon oral pouch product dosing within animals.
Lexaria recognizes that human oral pouch dosing is a growing trend in various locations around the world. This redesigned study will offer more measurable outcomes that will yield better results that will play an integral role in further research down the line.
So far, the contract has already been signed with an animal testing laboratory. Additionally, all the test articles have been manufactured and are being shipped to the lab for dosing purposes. Animal dosing is scheduled to start in July, and reporting will be provided as soon as there are significant developments in the study.
About Lexaria Bioscience Corp
Lexaria is a pioneer and global innovator in drug delivery platforms. Its patented technology, DehydraTECH(TM), has proven revolutionary in the delivery of fat-soluble active molecules and drugs. The technology functions by improving the way active pharmaceutical ingredients (“APIs”) enter the bloodstream, primarily through promoting healthier oral ingestion and increasing the efficacy of the fat-soluble active molecules.
This company relies on applied R&D programs to generate confirmatory results and data evidencing improved drug delivery characteristics that allow for the achievement of commercial opportunities and/or corporate relationships. The 2021 applied R&D program is the embodiment of Lexaria’s commitment to this course. Its status update on the six studies within the R&D program indicates bigger things to come for the company from a research standpoint.
For more information, visit the company’s website at www.LexariaBioscience.com.
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