LEXXW - Lexaria's DehydraTECH-CBD Diabetes Study Demonstrates Weight Loss Improved Triglyceride and Cholesterol Levels
(TheNewswire)
Kelowna, British Columbia – TheNewswire - March 2, 2023 –Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the“Company” or “Lexaria”), a global innovator in drug deliveryplatforms announces that its diabetes animalmodel study DIAB-A22-1 has completed and produced at least threepositive outcomes including weight loss in obese diabetic-conditionedanimals, together with improved triglyceride and cholesterollevels.
REDUCED BODY WEIGHT
Beginning just four days after the start of dosing withDehydraTECH-CBD, the obese rats began to lose weight. The weight losswas maximized nine days after dosing and maintained throughout the8-week study duration. This apparent trend demonstrated roughly a7% loss of body weight throughout the course of treatment at bothDehydraTECH-CBD doses studied (30 mg/Kg and 100 mg/Kg). Only theDehydraTECH-CBD-dosed animals weighed less at the end of the studythan at the beginning, whereas the weight of the untreated obeseanimals trended upwards throughout the study. The lean untreatedanimals gained the most weight of all to actually become obese by theend of the study.
Furthermore, in the DehydraTECH-CBD treated rats theweight loss trend observed did not appear to be a result of lowerlevels of food or water intake. Food and water intake was comparablein both the treated and untreated obese animal groups suggesting thatthe weight loss was more so related to enhanced metabolic function.
According to the National Institute for Health, obesity or being overweight is theleading cause of diabetes .
ACTIVITY LEVELS
Obesity is often accompanied by reduced activitylevels, which were measured in this study via locomotor activity, thedistance the animals travelled in open field observations. Interestingly, the lower dose of DehydraTECH-CBDresulted in a statistically significant improvement in locomotor activity compared to the untreated obese controlrats (*p<0.05), whereas there was no significant differenceaccordingly evidenced at the higher dose. As expected, activitylevels for all obese rats were significantly lower than the leancontrol rats (#p<0.05), although only the lower doseDehydraTECH-CBD treated rats approached the activity levels of thelean rats. Previous research has suggested that CBD may enhance motor activity through its action upon theserotonin 5-HT1A receptor.
Additional investigation will be required to learn whatan optimum DehydraTECH-CBD dose related to both weight loss and increased physical activity might be, given the fact that the higher dose studied mayhave elicited sedative-like effects of CBD triggering hypolocomotionwhich others have also observed upon highsystemic exposure .
TRIGLYCERIDE AND CHOLESTEROLLEVELS
Higher triglyceride levels in the blood can be an indication of the onsetof diabetes . One of the best ways to managetriglyceride levels is to lose weight. In study DIAB-A22-1, theanimals dosed with DehydraTECH-CBD showed statistically significantreductions in triglyceride levels from day 35 onwards compared to theobese animals not dosed with DehydraTECH-CBD. Once again, the lowerdose of 30 mg/Kg of DehydraTECH-CBD outperformed the higher dose of100mg/kg. By the end of the study the triglyceride levels in theanimals receiving 30 mg/Kg of DehydraTECH-CBD was over 25% lower thanthat of the untreated obese animals (*p=0.007).
Cholesterol levels in the animals receivingDehydraTECH-CBD were also higher. There are two types ofcholesterol – HDL and LDL – where HDLcholesterol is generally considered “good” and is desired and LDLcholesterol is generally considered “bad”, although some studies are beginning to questionwhether this is true . Again, the lower doseof 30 mg/Kg appeared to outperform the higher 100 mg/Kg dose ofDehydraTECH-CBD, with a trend toward increased HDL good cholesterolbut with no significant effect upon LDL bad cholesterol levelscompared to the untreated obese animals. The 100 mg/Kg dosed animalsdemonstrated increases in both desired HDL and the undesired LDLlevels, with significance relative to the untreated obese animals inthe latter instance (*p<0.05). The findings with the lower dosetherefore appeared to support improved physiological functionrelative to the diabetic state .
According to the American DiabetesAssociation , CBD is not thought to directly reduce blood glucose levels asprevious clinical studies have discovered,nor was any significant effect from DehydraTECH-CBD dosing on bloodglucose measured or expected in this study.
SUMMARY
Animal study DIAB-A22-1 evidenced, at times, dramaticchanges in body weight, general activity, and triglyceride andcholesterol levels associated with administration of DehydraTECH-CBD. These findings are well aligned with other study work in animals that points to the knownanti-inflammatory and antioxidant properties of CBD functioning to lessen some of the essentialpathophysiological factors associated with diabetes. Lexaria ispleased that relatively low doses of DehydraTECH-CBD seem to besupportive of real improvements in day-to-day health of the labanimals and the Company is very encouraged by the positive findingsfrom its first study of DehydraTECH-CBD in this diabetes animal model,indicating many prospective benefits worthy of further investigationtogether, perhaps, with other drugs that further help to controlglucose levels directly.
ABOUT THE STUDY
Study DIAB-A22-1 administered select Lexaria“DehydraTECH-CBD 2.0” formulations at doses of either 30 mg/Kg or100 mg/Kg of body weight in a total of 32 male Zucker “ZDF” rats -24 obese and 8 lean. The study length wasdoubled from four weeks of dosing to eight weeks of dosing, afterinitial positive early responses were witnessed. Treatment was well tolerated throughout the course of dosingwith no serious health concerns observed in the animals that receivedDehydraTECH-CBD. The health of some of the obese animals declinedafter the study had concluded as might be expected, likely as a resultof the advanced pathology and possible ketoacidosis from the prolongeddiabetic condition of these disease-model animals. Study DIAB-A22-1 was undertaken by a leading, third-partytesting laboratory located in Canada.
ABOUT THE DIABETES MARKETOPPORTUNITY
Diabetes is a disease whereby the body does not producesufficient insulin, leading to higher than normal levels of sugars inthe blood. Risks of kidney disease, vision loss, heartand cardiovascular disease and more aregreatly enhanced by individuals with diabetes. Because diabetes isoften closely connected to obesity, it is a chronic and growingproblem around much of the world.
People with type-2 diabetes can often control thedisease through lifestyle changes and/or taking certain diabetesmedications, whereas those with type-1 diabetes are required to addinsulin to their body through syringes, insulin pumps, or othersimilar devices. Thus the treatment of diabetes includes devices,drugs, and lifestyle alteration. The global diabetes devices market is estimated at $26.7 billion in2021 . The global diabetes drug market is estimated at $63.1 billion in2021 . Due to the pain and unpleasantness ofinjections, many diabetes sufferers prefer to treat their conditionwith drugs rather than devices, if they have the choice. More than 1.9billion people were overweight in 2016, and due to the growth inobesity, which has nearly tripled from 1975 to2016 , the number of people experiencingdiabetes continues to grow.
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 a licensed in-house research laboratory and holdsa robust intellectual property portfolio with 28 patents granted andmany 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.
INVESTOR CONTACT:
George Jurcic - Head of InvestorRelations
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