LEXXW - Lexaria to Evaluate Impact of DehydraTECH on Oral Performance of GLP-1 drugs used in products such as Ozempic Wegovy and Rybelsus Alone or Together with DehydraTECH-CBD
(TheNewswire)
DehydraTECH-powered GLP-1 drugs willbe evaluated for potential improvements such as:
-
Reduced side effects;
-
Enhanced weight loss;
-
Improved health outcomes fordiabetes and other conditions;
-
Improved oral bioavailability;
-
Reduced cost.
Kelowna, British Columbia – TheNewswire - September 21, 2023 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the“Company” or “Lexaria”), a global innovator in drug deliveryplatforms announces its intention to launch new human and animalstudies to examine DehydraTECH™-processed glucagon-like peptide-1 (“ GLP-1”) drugs such as, but not limited to, semaglutide sold under Novo Nordisk’s brand names Ozempic®,Wegovy® and Rybelsus®, for purposes of improved bioavailability,cost-effectiveness, tolerability, weight loss potential, managementof diabetes and other health conditions.
Through these studies, Lexaria hopes to achievesuperior pharmacokinetic (“PK”) performance usingDehydraTECH-powered GLP-1 drugs which could enable drug delivery viaoral capsule at lower costs than current injectables, with reducedside effects and enhanced health benefits.
This is a significant expansion of Lexaria’s ongoingand planned diabetes study program to examine its patentedDehydraTECH-CBD for diabetes control in humans. The Company nowintends to evaluate this alongside and together withDehydraTECH-processed GLP-1 agents. Program design has alreadycommenced, and initial study work will begin as soon aspossible.
Lexaria has demonstrated in many previous R&Dprograms, including five human clinical studies, that DehydraTECH cangreatly improve the PK performance of many orally administered drugsinto the bloodstream, such as certain antiviral drugs, estradiol,PDE-5 Inhibitors, cannabinoids and more. Like many of these agents,GLP-1 drugs also exhibit low oral bioavailability without the use ofabsorption enhancement technology, such as Lexaria’s DehydraTECH. Lexaria has also previously shown in animal studies that itspatented DehydraTECH-CBD lowered body weight over a sustained dosingperiod by 7%, and also lowered blood sugar and triglyceridelevels.
The Company has also demonstrated that specificcustomized DehydraTECH oral capsule formulations can achieveremarkable improvements in PK performance. For example, the particularDehydraTECH-CBD formulation that was used in its recently completed DIAB-A22-1 diabetes study demonstrated almost a 3-fold improvement in drugdelivery into blood than the differentiated DehydraTECH-CBDformulation that was used in Lexaria’s HYPER-H21-4 hypertension study that, itself, demonstrated significantly betterPK performance and effectiveness than pharmaceutical-grade CBD industrycomparators like Epidiolex ®.
About GLP-1 Drugs .
GLP-1 drugs have recently been approved by the Food andDrug Administration (“FDA”) for type two diabetes and weight lossmanagement. Weight loss of between 10 pounds to 33pounds , or more, has been widely reported.One 68-week study of 667 people reported an average loss of 15% of bodyweight .
Widely reported anecdotal commentary is also suggestingthat some patients are experiencing reduced cravings for alcohol, nicotineand opioids while taking GLP-1 drugs. Othertrials are examining their effects on heart disease and evendementia in part because of evidence thatGLP-1 drugs may reduce the build-up of the proteins amyloid and tau inthe brain, thought to be partly responsible for Alzheimer’sdisease.
Side effects of the GLP-1drugs vary but can include nausea, vomiting,diarrhea and more. A small number of GLP-1 drugs have already beenapproved in oral format but some studies have reported worse sideeffects with the oral form . The drugs arealso being investigated for their relationship to bone density, muscleloss and more. Because of potential serious side effects, it may bebeneficial to treat patients with lower oral doses of the drugs,something that Lexaria’s DehydraTECH technology may enable if it canimprove the PK performance of GLP-1 drugs through oralcapsules.
Although the GLP-1 drugs are effective at controllingdiabetes and promoting weight loss, they are expensive, and thebenefits often reverse if the patient stops taking the drug. Typical non-insured costs ofUS$900/month or more are common. IfDehydraTECH improves the PK performance of oral GLP-1 drugs it couldpotentially result in cost savings for the patient through lowerdoses.
Because GLP-1 drugs have experienced FDA approvals asrecently as 2021 and 2022, and because the health benefits of thisdrug class are still being discovered and understood, the potentialmarket size is still unknown. Published reports are widely estimating$100 billion in sales per year, by 2030. At least one analyst fromGuggenheim Partners published a note on September 12 in which he explained how “the total addressable market forthese so-called incretin drugs could balloon to $150 billion to $200billion .”
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 in pre-clinical diabetes study DIAB-A22-1 inobese diabetic-conditioned animals, DehydraTECH-CBD achieved each ofthe following:
-
Lowered blood glucose levels by 19.9% (p0.05)
-
Lowered overall body weight by 7% sustained over 8weeks
-
Increased locomotor activity (p0.05)
-
Lowered triglyceride levels by more than 25%(p0.007)
-
Lowered blood urea nitrogen levels by 27.9%(p0.001)
On August 2, 2023 Lexaria announced itsintention to study weight loss and diabetescontrol in a human population using DehydraTECH-CBD.
Lexaria’s goals within its diabetes study programhave significantly expanded and now include the concept of applyingDehydraTECH technology, individually, to each of CBD and GLP-1drug(s), but also to potentially utilize a combination of drugs thatincludes both a GLP-1 component and DehydraTECH-CBD, together. At thistime, no other company in the world is utilizing DehdyraTECHtechnology relative to GLP-1 drugs.
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 blood sugarlevels 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 be ineffective incontrolling 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 isdesigned to improve the way active molecules enter the bloodstreamupon oral ingestion. DehydraTECH has also demonstrated enhanceddelivery of certain active molecules into brain tissue, which Lexariabelieves to be of particular importance for centrally activecompounds. Lexaria has also developed DehydraTECH formulations forother applications demonstrating superior bio-absorption whenadministered 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 36 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 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 theseforward-looking statements. As such, you should not place unduereliance on these forward-looking statements. Factors which couldcause actual results to differ materially from those estimated by theCompany include, but are not limited to, government regulation andregulatory approvals, managing and maintaining growth, the effect ofadverse publicity, litigation, competition, scientific discovery, thepatent application and approval process, potential adverse effectsarising from the testing or use of products utilizing the DehydraTECHtechnology, the Company’s ability to maintain existingcollaborations and realize the benefits thereof, delays orcancellations of planned R&D that could occur related to pandemicsor for other reasons, and other factors which may be identified fromtime to time in the Company's public announcements and periodicfilings with the US Securities and Exchange Commission on EDGAR. TheCompany provides links to third-party websites only as a courtesy toreaders and disclaims any responsibility for the thoroughness,accuracy or timeliness of information at third-party websites. Thereis no assurance that any of Lexaria’s postulated uses, benefits, oradvantages for the patented and patent-pending technology will in factbe realized in any manner or in any part. No statement herein has beenevaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat,cure or prevent any disease. Any forward-looking statements containedin this release speak only as of the date hereof, and the Companyexpressly disclaims any obligation to update any forward-lookingstatements or links to third-party websites contained herein, whetheras a result of any new information, future events, changedcircumstances or otherwise, except as otherwise required bylaw.
INVESTOR CONTACT:
George Jurcic - Head of InvestorRelations
Copyright (c) 2023 TheNewswire - All rights reserved.