LEXXW - Lexaria's Technology Lowers Blood Glucose More Effectively than Rybelsus-Branded GLP-1 drug Semaglutide Alone in Human Pilot Study
(TheNewswire)
DehydraTECH TM -powered semaglutide achieved thesebenefits in a human pilot study compared to Rybelsus ® :
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Sustained lower levels of bloodglucose from baseline including nearly 10x lower after 24 hours;
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Lower blood-glucose spike aftereating; and
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Successful first-ever DehydraTECHtest with a “large molecule” drug.
Kelowna, British Columbia - TheNewswire - November 28, 2023 - Lexaria Bioscience Corp. (Nasdaq: LEXX & LEXXW) (the“ Company ” or “ Lexaria ”), a global innovator in drugdelivery platforms announces additional positive interim results froma human pilot study (the “ Study ”) evaluating DehydraTECH TM technology forthe oral delivery of the glucagon-like peptide-1 (“ GLP-1 ”) drugsemaglutide available commercially in the branded product Rybelsus®,further to its previously announcedfindings from this work.
The Study was performed by a prominent universityresearch center comparing a single 7 mg semaglutide dose of a Rybelsustablet (“ Control ”) to a matching dose from Rybelsus that had been compoundformulated in capsule form using DehydraTECH processing technologyenhancements (“ DehydraTECHGLP-1 ”).
Blood Glucose Levels
It is accepted by the Food and Drug Administration(“ FDA ”) that, “ onerole of GLP-1 isto prompt the body to produce more insulin, which reduces bloodglucose (sugar) .” Because blood glucose levelsare a key consideration in control of diabetes and other healthconditions, the Study measured blood glucose levels at each of the 19sample time points.
The Control group evidenced reduced blood glucoselevels by between 1.3% and 6.7% relative to the time zero baselineduring the first 100 minutes of the Study. The DehydraTECH GLP-1 groupevidenced reduced blood glucose levels by between 2.9% and 14.6%relative to baseline during those same initial 100 minutes. At all butthe 20-minute and 240-minute sample time points,the DehydraTECH GLP-1 blood glucose levels were reduced more thanevidenced by the Control group.
Notably, even as long as 24 hours after doseadministration, the blood glucose levels were reduced in theDehydraTECH GLP-1 group by 6.3% relative to baseline while the bloodglucose level evidenced in the Control group was only reduced by0.67%, evidencing nearly a ten-fold improvement with the DehydraTECHGLP-1. (Only the first 10 hours of study results displayed in thegraph above.)
Of particular note, blood glucose levels spiked by22.7% in the Control group after the subjects were permitted to eat astandardized meal at the 240-minute mark and a standardized snack atthe 360-minute mark. Although the DehydraTECH GLP-1 subjectsconsumed choices of similar meals and snacks at the same times, theirblood glucose levels rose by only 5.3%. It is not presently knownwhether the higher sustained levels of blood semaglutide delivery byDehydraTECH GLP-1 enabled greater efficacy in achieving sustainedblood glucose reduction, thereby helping to attenuate the postprandialspikes in blood glucose experienced in the Control group, althoughthis may be a plausible explanation for the difference.
This Study is only meant to provide early-stageindicative information to Lexaria about the possibility of enhancingthe pharmacokinetic (“PK”) and pharmacodynamic performance oforally delivered GLP-1 drugs to assist in guiding the Lexaria team inadditional investigations. There was minor variability in the diets ofthe subjects at the 240-minute meal and 360-minute snack intervalsnoted above during the concentrated 10-hour post dosing monitoringperiod which could account for some of the differences in the testdata, although meal and snack selection allowance was from a set ofstandardized choices.
Ongoing and Future Work
This Study is not complete and additional results willbe reported, likely in late December or early January following thecross-over Study visit as described below. Giventhe small sample size of this Study, it was not sufficiently poweredfor statistical significance analysis, which will be a key part of anyexpanded studies with DehydraTECH GLP-1 undertaken in thefuture.
Parallel to Lexaria’s 2021 optimization program withDehydraTECH-processed cannabidiol (“CBD”), where the formulationutilized in the animalstudy DIAB-A22-1 demonstrated 364%higher (p=0.0002) PK performance thanLexaria’s original DehydraTECH-CBD formulations, we expect to createseveral different DehydraTECH GLP-1 formulations to explore deliveryand performance optimization of semaglutide. As seen with our pastDehydraTECH-CBD advancements, Lexaria will endeavor to similarlyimprove performance of future DehydraTECH-GLP-1 formulations.
About the Study
The Study was performed to provide an early-stageindication of whether DehydraTECH processing could improve oral drug delivery characteristics of the GLP-1 drug semaglutide sold asRybelsus. A single semaglutide dose of 7 mg of the Rybelsus Controlwas compared to the matching dose of theDehydraTECH GLP-1, swallowed by each subject after an overnightfasting period together with a 50 mL glass of water. The DehydraTECHGLP-1 formulation used in this Study was compound formulated strictlyfor research purposes. Seven healthy subjects were dosed, four of whomreceived the DehydraTECH GLP-1, and three of whom received theControl. These seven subjects are expected to return to the Study sitein December to be dosed a second time in the reverse order followingthe “cross-over” design of this Study to ensure that all sevensubjects will have been treated with both the Control and DehydraTECHGLP-1 treatments over the course of the two visits.
Semaglutide is the first so-called “large molecule”ever evaluated with DehydraTECH processing. Lexaria has typicallyworked with drugs and bioactive substances that are considered“small molecules” with low molecular weights. Large molecules,on the other hand, generally have much larger molecular weights of3000 daltons or greater, are often but not always biolociallyderived and are obviously morecomplex. At this time Lexaria does not know whether DehydraTECH mayoffer performance improvements to any significant quantity of largemolecule drugs, but, if so, this could represent a radically expanded suiteof drugs that may potentially beprocessed with DehydraTECH.
About Lexaria’s Diabetes StudyProgram.
Lexaria began its DehydraTECH diabetes-related formalstudies in 2022. On March 2,2023 and June 16,2023 Lexaria announced that inpre-clinical diabetes study DIAB-A22-1 in obesediabetic-conditioned animals, DehydraTECH-CBD achieved each of thefollowing:
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Lowered blood glucose levels by 19.9% (p0.05)
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Lowered overall body weight by 7% sustained over 8weeks
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Increased locomotor activity (p0.05)
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Lowered triglyceride levels by more than 25%(p0.007)
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Lowered blood urea nitrogen levels by 27.9%(p0.001)
On August 2, 2023 Lexaria announced itsintention to study weight loss anddiabetes control in a human population using DehydraTECH-CBD.
DehydraTECH-CBD’s ability to reduce blood sugarlevels in animals is extremely encouraging and warrants additionalinvestigation. According to the Center for Disease Control, managing your bloodsugar levels is important to avoiddiabetes-related conditions such as vision loss, heart disease, andkidney disease. Limited research, mostly in animal studies, indicatesthat without DehydraTECH’s noteworthy performance enhancements, generic CBD might beineffective in controlling blood sugars .
About DehydraTECH
DehydraTECH is a patented drug delivery formulation andprocessing platform technology Lexaria has developed and isinvestigating for a variety of beneficial molecules. DehydraTECH is designed to improve the way active moleculesenter the bloodstream upon oral ingestion. DehydraTECH has alsodemonstrated enhanced delivery of certain active molecules into braintissue, which Lexaria believes to be of particular importance forcentrally active compounds. Lexaria has also developed DehydraTECHformulations for other applications demonstrating superiorbio-absorption when administered intraorally and topically.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s patented drug deliverytechnology, DehydraTECH™, improves the way active pharmaceuticalingredients (APIs) enter the bloodstream through oral delivery. Since2016, DehydraTECH has repeatedly demonstrated the ability to increasebio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors andmore. DehydraTECH has also evidenced an ability to deliver some drugsmore effectively across the blood brain barrier. Lexaria operates alicensed in-house research laboratory and holds a robust intellectualproperty portfolio with 37 patents granted and many patents pendingworldwide. For more information, please visit www.lexariabioscience.com .
CAUTION REGARDING FORWARD-LOOKINGSTATEMENTS
This press release includes forward-looking statements.Statements as such term is defined under applicable securities laws.These statements may be identified by words such as"anticipate," "if," "believe,""plan," "estimate," "expect,""intend," "may," "could,""should," "will," and other similar expressions.Such forward-looking statements in this press release include, but arenot limited to, statements by the Company relating to the Company’sability to carry out research initiatives, receive regulatoryapprovals or grants or experience positive effects or results from anyresearch or study. Such forward-looking statements are estimatesreflecting the Company's best judgment based upon current informationand involve a number of risks and uncertainties, and there can be noassurance that the Company will actually achieve the plans,intentions, or expectations disclosed in these forward-lookingstatements. As such, you should not place undue reliance on theseforward-looking statements. Factors which could cause actual resultsto differ materially from those estimated by the Company include, butare not limited to, government regulation and regulatory approvals,managing and maintaining growth, the effect of adverse publicity,litigation, competition, scientific discovery, the patent applicationand approval process, potential adverse effects arising from thetesting or use of products utilizing the DehydraTECH technology, theCompany’s ability to maintain existing collaborations and realizethe benefits thereof, delays or cancellations of planned R&D thatcould occur related to pandemics or for other reasons, and otherfactors which may be identified from time to time in the Company'spublic announcements and periodic filings with the US Securities andExchange Commission on EDGAR. The Company provides links tothird-party websites only as a courtesy to readers and disclaims anyresponsibility for the thoroughness, accuracy or timeliness ofinformation at third-party websites. There is no assurance that any ofLexaria’s postulated uses, benefits, or advantages for the patentedand patent-pending technology will in fact be realized in any manneror in any part. No statement herein has been evaluated by the Food andDrug Administration (FDA). Lexaria-associated products are notintended to diagnose, treat, cure or prevent any disease. Anyforward-looking statements contained in this release speak only as ofthe date hereof, and the Company expressly disclaims any obligation toupdate any forward-looking statements or links to third-party websitescontained herein, whether as a result of any new information, futureevents, changed circumstances or otherwise, except as otherwiserequired by law.
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