(TheNewswire)
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DehydraTECH appears to work with asecond GLP-1 drug – liraglutide
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DehydraTECH appears to be workingwith semaglutide both with and without SNAC technology
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DehydraTECH-CBD is showing strongapparent performance relative to GLP-1
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Dosing in the final four study armshas now begun
Kelowna, British Columbia – TheNewswire - July 17, 2024 – Lexaria Bioscience Corp. (Nasdaq: LEXX &LEXXW) (the “Company” or “Lexaria”), a global innovator indrug delivery platforms announces that interim results from the firstfour weeks of dosing in its ongoing diabetes animal study WEIGHT-A24-1(the “Study”) have been received and have already produced severalnoteworthy findings.
Unlimited food and water has been provided to theanimals for the entire duration of the Study. During the initialacclimation phase of 34 days before the beginning of dosing, the animalsgained 10.9% body weight on average. During the subsequent 28 days ofDehydraTECH-processed drug therapy dosing, all test articles showedeither a stark decrease in the rate of body weight gain or, in selectcases, the beginning of body weight reduction. DehydraTECH-CBDformulation 3 (“CBD3”) and DehydraTECH-liraglutide have producedthe largest weight loss results thus far of -1.50% and -1.58%,respectively. Of note, only in Study arms A, B, C, and E did anyindividual animals lose 5.0% or more body weight during these first 28days of treatment. An additional 56 days of dosing remains across alltreatment groups.
Animal Weights (grams)
DehydraTECH Groups | Arrival in Lab | End of Acclimation Period | % Change to End of Acclimation | End of 28 Days of Dosing | % Change to Day 28 |
A: CBD1 | 386.0 | 427.9 | +10.9% | 432.6 | +0.96% |
B: CBD2 | 360.6 | 394.6 | +9.4% | 393.3 | -0.59% |
C: CBD3 | 375.5 | 416.0 | +10.8% | 408.8 | -1.50% |
D: CBD4 | 377.2 | 431.2 | +14.3% | 431.7 | +0.32% |
E: Rybelsus1 | 365.1 | 394.9 | +8.2% | 394.6 | +0.07% |
F: Rybelsus2 | 364.5 | 406.2 | +11.4% | 409.1 | +0.72% |
G: Semaglutide | 352.7 | 394.2 | +11.8% | 394.8 | +0.16% |
H: Liraglutide | 354.6 | 392.2 | +10.6% | 385.7 | -1.58% |
Average | 367.0 | 407.1 | +10.9% | 406.3 | -0.18% |
-Weights shown are average of six animals pergroup.
- Groups A through D were varying DehydraTECH-CBDcompositions
- Groups E and F were reformulated Rybelsus®compositions including DehydraTECH and the sodium salcaprozate(“SNAC”) technology
- Groups G and H used pure GLP-1 drugs (semaglutide andliraglutide respectively) without SNAC inclusion
This is the first time that DehydraTECH processing wasapplied to the GLP-1 drug liraglutide, and it is encouraging towitness its relative outperformance. Although liraglutide wasadministered as an oral DehydraTECH-enabled dose in this Study, it iscurrently only sold and prescribed as a subcutaneous injection (seebelow for more context). Liraglutide is currently available commercially by Novo Nordisk ® sold under the brand namesVictoza ® andSaxenda ® , but the related patents havebegun to expire and open the door tonew competitors. For example, Teva Pharmaceutical Industries Ltd®recently launched the firstgeneric injectable version of thisGLP-1 drug.
Study arm G is the first time that pure semaglutide wastested with DehydraTECH processing without the SNAC technology foundwithin the Rybelsus ® tablets. It is of interest that it has, so far, apparently performednearly identically in body weight gain attenuation to Study arm Ewhich is the best performing DehydraTECH-processed reformulatedRybelsus® composition that includes the SNAC technology.
Another important objective has now been reached inevaluating the results of the first 28 days of dosing among the firsteight Study arms that, together, constitute Cohort 1 of the Study:Performance superiority has been observed among the variousformulations, allowing the Study team to select the best performersfor inclusion in the subsequent Cohort 2 Study work. Dosing in thosefinal four Study arms that constitute Cohort 2 of the Study has begunand is expected to be completed in mid-October.
Those final four Study arms include a positive controlarm (commercially available Rybelsus®) and a placebo arm, as well asa combined DehydraTECH-semaglutide with DehydraTECH-CBD arm (Groups C+ E), and a combined DehydraTECH-liraglutide with DehydraTECH-CBD arm(Groups C + H).
In all cases and as per design in an exploratory,directionally informative Study of this nature, animal populationswere not intended to be large enough to necessarily evidencestatistical significance, and readers are reminded that these data areindicative only of apparent trends that have not been analysedstatistically. Blood glucose data for the first four weeks of dosinghas also been received, is being processed, andwill be released soon. Pharmacokinetic (“PK”) data for the firstfour weeks has not arrived yet and will be released when available.
Brain absorption data can only be collected at the endof the 12-week study and will also be released when available. Readers are encouraged to review our May 17, 2024press release that provides athorough explanation of the comprehensive Study design and rationale,including why possible enhancement of brain absorption is believed tobe of potential significance.
About Liraglutide
Liraglutide is owned by Novo Nordisk® and sold underthe Victoza® and Saxena® brands which generated $1.6 billionin combined revenue in 2022.Liraglutide is currently administered only by injection, afterattempts to utilize the SNAC technology found in semaglutide (and soldas the oral tablet Rybelsus®) failed to deliver sufficientperformance to enable an oral form factor.
Previous investigatorsreported that “the absorption enhancing action of SNAC isthought to be highly dependent on the specific agent it is enhancing,which means that carefully tailored co-formulation is required ratherthan co-administration. The structure of liraglutide (a structurallydistinct analog of GLP-1RA) was found to be unfavorable forco-formulation with SNAC on account of its stronger membrane-bindingproperties, which reduced transcellular passage, as well as itsgreater tendency to oligomerize, which countered the monomerizingeffects of SNAC. In a preclinical study, plasma exposure wassignificantly higher for semaglutide than liraglutide after oraldosing with SNAC. ”
About the Study
Study WEIGHT-A24-1 is underway using diabetic,pre-conditioned Zucker rats. Each arm of the Study is expected to bedosed for a 12-week period following the initial acclimation period.During the Study, over 1,500 blood plasma samples will be collectedfrom the total rat population of 72 animals for purposes of detailedPK drug delivery analyses. Body weight and blood glucose readings weretaken prior to Study start continuing at regular intervals during andat conclusion of the dosing period. Upon completion of the Study,brain tissue will be analysed to help determine whether DehydraTECHprocessing results in higher brain absorption than non-DehydraTECHarms, as Lexaria has evidenced numerous times in previous similaranimal studies. The Study will also include a comprehensive battery ofliver and kidney function testing and blood chemistry analyses. LC-MS/MS and othertechniques will be used to analyse samples.
About Lexaria Bioscience Corp. &DehydraTECH
DehydraTECH™ is Lexaria’s patented drug deliveryformulation and processing platform technology which improves the wayactive pharmaceutical ingredients (APIs) enter the bloodstream throughoral delivery. Since 2016, Lexaria has developed and investigatedDehydraTECH with a variety of beneficial molecules in oral and topicalformats. DehydraTECH has repeatedly demonstrated the ability toincrease bio-absorption and has also evidenced an ability to deliversome drugs more effectively across the blood brain barrier, whichLexaria believes to be of particular importance for centrally activecompounds. Lexaria operates a licensed in-house research laboratoryand holds a robust intellectual property portfolio with 46 patentsgranted and many patents pending worldwide. 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 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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