LEXXW - Lexaria's Patented Technology Improved the Oral Performance of the Rybelsus-Branded GLP-1 drug Semaglutide

(TheNewswire)

Final results from a human pilotstudy show DehydraTECH TM -powered semaglutide outperforms Rybelsus ® :

• Sustained higher levels ofsemaglutide in blood;

• Better blood glucosecontrol;

• Faster achievement of peak drugdelivery; and

• Reduced side effects.

Kelowna, British Columbia –TheNewswire -- January 4, 2024 – LexariaBioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the “Company” or“Lexaria”), a global innovator in drug delivery platformsannounces positive final results from its recently completed humanPilot Study #1 (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®.

The Study was performed by a prominent universityresearch center comparing a single 7 mg semaglutide dose of a Rybelsus® tablet (“ Control ”) to amatching dose from Rybelsus that had been compound formulated incapsule form using DehydraTECH processing technology enhancements(“ DehydraTECHGLP-1 ”).

In general, the DehydraTECH processing enabledimprovements in delivery of semaglutide to the bloodstream, and theimprovements in controlling blood sugar were more pronounced in thefinal combined results of the Study than they were in the first halfof the Study as reported in press releases issued November27 and November28 , 2023.

Blood Levels of Semaglutide

The first post-baseline blood was sampled 20 minutesafter oral administration and, at that point in time, the DehydraTECHGLP-1 blood semaglutide level was ~261% higher than that of theControl, demonstrating DehydraTECH’s well-known ability to deliverdrugs to the bloodstream faster. At each of the 19 blood sample timepoints, the DehydraTECH GLP-1 blood semaglutide levels were higherthan the Control levels.  The peak levels of semaglutide in bloodwere 43% higher in the DehydraTECH GLP-1 than in the Rybelsus®Control.

Blood Semaglutide Levels(mmol/L)

Rybelsus Control ( blue ) 7mg (n=7)    DehydraTECH ( orange ) GLP-1 7mg (n=7)

24 hours after the ingestion of the single dose, theDehydraTECH GLP-1 blood semaglutide levels were approximately 44%higher than the Control levels (Note - only the first 10 hours postdosing is shown in the graph above).

Side Effects

The DehydraTECH GLP-1 processed semaglutide wasgenerally better tolerated than the Rybelsus® tablets themselves.O nly the Rybelsus ® tablets resulted in instances ofmoderate nausea and moderate diarrhea, whereas no such instances werereported upon DehydraTECH-semaglutide dosing .

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.

Blood Glucose Levels (mmol/L)

Rybelsus Control  ( blue ) 7mg (n=7)    DehydraTECH( orange ) GLP-1 7mg(n=7)

The Control group evidencedinconsistent blood glucose reduction that did not prevent bloodglucose spikes after eating. DehydraTECH GLP-1 reduced blood glucoseto lower levels and was much more effective at maintainingconsistently reduced blood glucose levels even after eating astandardized meal at the 240-minute mark and a standardized snack atthe 360-minute mark. Actual data levels for each hour afterRybelsus ® (control) andDehydraTECH drug administration are shown below.

Blood Glucose Levels (mmol/L)

Notably, even as long as 24 hours after doseadministration, the blood glucose levels were reduced in theDehydraTECH GLP-1 group by 5.01% relative to baseline while the bloodglucose levels evidenced in the Rybelsus ® Controlgroup were unchanged. Our current assumption is that the improveddelivery of semaglutide using DehydraTECH is most likely responsiblefor the observed greater efficacy in achieving sustained blood glucosereduction, thereby helping to attenuate the postprandial spikes inblood glucose experienced in the Control group.

This Study is only meant to provide early-stageindicative information to Lexaria about the possibility of enhancingthe pharmacokinetic and pharmacodynamic performance of orallydelivered 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.

Future Work

Due to the success of the Study, Lexaria is alreadypreparing for other human and animal studies to continue theevaluation of DehydraTECH’s effectiveness with GLP-1 drugs. Thiswork will be conducted on an expedited basis given the urgent need foreffective oral delivery of GLP-1 drugs and DehydraTECH’s apparentability to improve their performance. Lexaria will provide moredetails about its GLP-1 strategy in separate news.

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 Control was compared to the matching dose of the DehydraTECHGLP-1, swallowed by each subject after an overnight fasting periodtogether with a 50 mL glass of water. The DehydraTECH GLP-1formulation used in this Study was compound formulated strictly forresearch purposes. Seven healthy subjects were dosed with each testarticle following a cross over study design across two study visits.

About Semaglutide

Rybelsus® (semaglutide) is the only GLP-1 drugapproved by the FDA for oral dosing to treat diabetes and weightloss. The FDA has also approved semaglutide marketed asOzempic ® andWegovy ® , administered by injection , to treat diabetes and weight loss. All three of these drugsare owned and manufactured by Novo Nordisk®.

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 38 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.

INVESTOR CONTACT:

George Jurcic - Head of InvestorRelations

ir@lexariabioscience.com

Phone: 250-765-6424, ext202

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