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Positive Interim Blood Sugar Results from Lexaria's GLP-1 Diabetes Animal Study

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Lexaria Bioscience Corp. (NASDAQ:LEXX) has announced positive interim blood sugar results from its ongoing GLP-1 diabetes animal study WEIGHT-A24-1. Key findings include:

1. DehydraTECH-liraglutide and two DehydraTECH-CBD formulations showed the best performance at day 56, with blood sugar level reductions of 2.50%, 1.90%, and 1.53% respectively.

2. All 8 active groups experienced smaller increases or actual decreases in blood sugar levels compared to the obese control group from a previous study.

3. DehydraTECH-liraglutide outperformed DehydraTECH-semaglutide, which is notable as semaglutide typically outperforms liraglutide in human studies without DehydraTECH processing.

The study is ongoing, with additional results expected soon.

Lexaria Bioscience Corp. (NASDAQ:LEXX) ha annunciato risultati interni positivi sui livelli di zucchero nel sangue dal suo studio animale sulla diabetes GLP-1 WEIGHT-A24-1. I risultati chiave includono:

1. DehydraTECH-liraglutide e due formulazioni DehydraTECH-CBD hanno mostrato le migliori performance al giorno 56, con riduzioni dei livelli di zucchero nel sangue rispettivamente del 2,50%, 1,90% e 1,53%.

2. Tutti e 8 i gruppi attivi hanno registrato aumenti minori o addirittura diminuzioni dei livelli di zucchero nel sangue rispetto al gruppo di controllo obeso di uno studio precedente.

3. DehydraTECH-liraglutide ha superato DehydraTECH-semaglutide, il che è notevole poiché di solito il semaglutide supera il liraglutide negli studi umani senza il processo DehydraTECH.

Lo studio è in corso, con ulteriori risultati attesi a breve.

Lexaria Bioscience Corp. (NASDAQ:LEXX) ha anunciado resultados interinos positivos de azúcar en sangre de su estudio en animales sobre diabetes GLP-1 WEIGHT-A24-1. Los hallazgos clave incluyen:

1. DehydraTECH-liraglutida y dos formulaciones DehydraTECH-CBD mostraron el mejor rendimiento en el día 56, con reducciones de los niveles de azúcar en sangre del 2,50%, 1,90% y 1,53% respectivamente.

2. Los 8 grupos activos experimentaron aumentos más pequeños o incluso disminuciones en los niveles de azúcar en sangre en comparación con el grupo de control obeso de un estudio anterior.

3. DehydraTECH-liraglutida superó a DehydraTECH-semaglutida, lo cual es notable ya que el semaglutide suele superar al liraglutide en estudios humanos sin el procesamiento DehydraTECH.

El estudio sigue en curso, con resultados adicionales esperados pronto.

Lexaria Bioscience Corp. (NASDAQ:LEXX)은 현재 진행 중인 GLP-1 당뇨병 동물 연구 WEIGHT-A24-1에서 양성의 중간혈당 결과를 발표했습니다. 주요 발견은 다음과 같습니다:

1. DehydraTECH-리라글루타이드와 두 가지 DehydraTECH-CBD 조제물이 56일째에 가장 우수한 성과를 보이며 각각 2.50%, 1.90%, 1.53%의 혈당 감소를 기록했습니다.

2. 모든 8개의 활성 그룹은 이전 연구의 비만 대조군과 비교하여 혈당 수치가 더 적게 증가하거나 실제로 감소했습니다.

3. DehydraTECH-리라글루타이드가 DehydraTECH-세마글루타이드보다 우수했는데, 이는 세마글루타이드가 일반적으로 DehydraTECH 처리 없이 사람 연구에서 리라글루타이드를 초월하는 것으로 보이기 때문에 주목할 만합니다.

연구는 진행 중이며 추가 결과가 곧 나올 예정입니다.

Lexaria Bioscience Corp. (NASDAQ:LEXX) a annoncé des résultats intermédiaires positifs sur la glycémie issus de son étude animale sur le diabète GLP-1 WEIGHT-A24-1. Les principaux résultats comprennent :

1. DehydraTECH-liraglutide et deux formulations DehydraTECH-CBD ont montré la meilleure performance au jour 56, avec des réductions des niveaux de glycémie de 2,50 %, 1,90 % et 1,53 % respectivement.

2. Tous les 8 groupes actifs ont connu des augmentations plus faibles ou des diminutions effective des niveaux de glycémie par rapport au groupe témoin obèse d'une étude précédente.

3. DehydraTECH-liraglutide a surpassé DehydraTECH-semaglutide, ce qui est notable puisque le semaglutide surpasse généralement le liraglutide dans les études humaines sans le traitement DehydraTECH.

L'étude est en cours, avec d'autres résultats attendus prochainement.

Lexaria Bioscience Corp. (NASDAQ:LEXX) hat positive Zwischenwerte zum Blutzucker aus seiner laufenden GLP-1-Diabetes-Tierstudie WEIGHT-A24-1 bekanntgegeben. Zu den wichtigsten Ergebnissen gehören:

1. DehydraTECH-Liraglutid und zwei DehydraTECH-CBD-Formulierungen zeigten am Tag 56 die beste Leistung mit einer Reduktion der Blutzuckerwerte um 2,50%, 1,90% und 1,53%.

2. Alle 8 aktiven Gruppen erlebten im Vergleich zur fettleibigen Kontrollgruppe einer früheren Studie geringere Erhöhungen oder tatsächliche Rückgänge der Blutzuckerwerte.

3. DehydraTECH-Liraglutid übertraf DehydraTECH-Semaglutid, was bemerkenswert ist, da Semaglutid in menschlichen Studien ohne DehydraTECH-Verarbeitung normalerweise Liraglutid übertrifft.

Die Studie ist noch im Gange, und weitere Ergebnisse werden bald erwartet.

Positive
  • DehydraTECH-liraglutide showed a 2.50% reduction in blood sugar levels at day 56
  • Two DehydraTECH-CBD formulations demonstrated blood sugar level reductions of 1.90% and 1.53% at day 56
  • All active treatment groups showed improved blood sugar control compared to the obese control group from a previous study
  • DehydraTECH-liraglutide outperformed DehydraTECH-semaglutide, suggesting potential advantages of Lexaria's proprietary technology
Negative
  • Semaglutide groups did not show actual decreases in blood sugar levels by day 56

Insights

The interim results from Lexaria's animal study on DehydraTECH-enabled GLP-1 and CBD formulations for diabetes are intriguing. The 2.50% reduction in blood sugar levels with DehydraTECH-liraglutide is particularly noteworthy, especially when compared to the performance of semaglutide formulations. This suggests that Lexaria's DehydraTECH technology might enhance liraglutide's efficacy, potentially challenging the current market dominance of semaglutide-based treatments.

The performance of DehydraTECH-CBD formulations, showing blood sugar reductions of 1.90% and 1.53%, is also significant. It hints at a possible role for CBD in diabetes management, particularly if used in combination with GLP-1 drugs. This could open up new treatment avenues and potentially expand the market for both CBD and GLP-1 therapies in diabetes care.

However, it's important to note that these are interim animal study results. Human trials will be necessary to confirm these effects and their clinical relevance. The ongoing combination studies of DehydraTECH-CBD with DehydraTECH-GLP-1 drugs will be critical in assessing the potential synergistic effects and could be a game-changer if positive results are replicated in humans.

Lexaria's interim results present a potentially significant market opportunity. The outperformance of DehydraTECH-liraglutide over semaglutide formulations is particularly interesting from a financial perspective. With liraglutide patents expiring and generic versions entering the market, Lexaria's DehydraTECH technology could offer a competitive edge in the lucrative GLP-1 market, estimated to reach $50 billion annually by 2025.

The potential for DehydraTECH-CBD in diabetes management also opens up new revenue streams. The global CBD market is projected to grow at a CAGR of 21.7% from 2021 to 2028 and a diabetes application could significantly boost this growth. However, investors should remain cautious as these are early-stage results and regulatory hurdles for CBD in medical applications remain significant.

Lexaria's stock (NASDAQ:LEXX) may see increased interest following these results, but it's important to consider that commercialization is still a long way off. The company will need substantial capital for human trials and potential commercialization, which could lead to dilution for current shareholders. While promising, these results should be viewed as a early-stage development in Lexaria's pipeline.

  • DehydraTECH-liraglutide is showing apparent superiority to DehydraTECH-semaglutide

  • Select DehydraTECH-CBD formulations are showing apparent superiority to DehydraTECH-GLP-1 at 4 and 8 weeks

KELOWNA, BC / ACCESSWIRE / August 21, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX) & (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that it has received 4-week and 8-week blood glucose results from ongoing animal study WEIGHT-A24-1 (the "Study").

DehydraTECH-liraglutide (Group H) and two DehydraTECH-CBD formulations (Groups A & B) were the top performers in the Study at day 56, with blood sugar level reductions of 2.50%, 1.90% and 1.53% respectively. This appears to support Lexaria's belief that DehydraTECH-CBD may have utility, especially if used together with a GLP-1 drug, in diabetic control. Animal testing of combination DehydraTECH-CBD with DehydraTECH-GLP-1 drugs is ongoing and in the final phases of the Study.

For context, in Lexaria's diabetic animal study DIAB-A22-1 reported on March 2, 2023, the obese control group of animals that received no treatment experienced 16.7% blood sugar concentration increases, relative to baseline by day 56 of that study. In the current Study, each of the 8 active groups of animals either experienced a smaller increase, or an actual decrease in blood sugar level relative to baseline as compared to the obese control group in the previous study. Interestingly, none of the animals receiving semaglutide experienced actual decreases by day 56 although some decreases were observed at day 28.

Blood Sugar Levels (nmol/L)

DehydraTECH Groups

Day 7 Baseline

Day 28

% Change to Day 28

Day 56

% Change to Day 56

A: CBD1

27.4

26.2

-4.31

26.9

-1.90

B: CBD2

28.4

29.2

4.05

26.6

-1.53

C: CBD3

26.4

24.9

-5.99

27.1

2.46

D: CBD4

24.6

27.9

13.16

26.8

8.94

E: Rybelsus1
w/SNAC

26.4

25.5

-3.60

26.8

1.33

F: Rybelsus2
w/SNAC

24.9

26.8

7.70

26.4

5.96

G: Semaglutide
No SNAC

26.3

25.9

-1.52

27.8

5.54

H: Liraglutide
No SNAC

26.4

25.8

-2.08

25.2

-2.50

Notes:

  • Groups A through D were different DehydraTECH-CBD compositions

  • Groups E and F were reformulated Rybelsus DehydraTECH compositions

  • Groups G and H used pure GLP-1 drugs (semaglutide and liraglutide respectively)in DehydraTECH compositions

The continued relative outperformance of DehydraTECH liraglutide is extremely interesting, in part because of Lexaria's proprietary DehydraTECH technology and its applicability to GLP-1 molecules. In other human studies, semaglutide tends to outperform liraglutide in blood sugar control, when not processed with DehydraTECH.

Liraglutide is currently available commercially by Novo Nordisk® sold under the brand names Victoza® and Saxenda®, but the related patents have begun to expire and open the door to new competitors. For example, Teva Pharmaceutical Industries Ltd® recently launched the first generic injectable version of this GLP-1 drug. Although liraglutide was administered as an oral DehydraTECH-enabled dose in this Study, it is currently only sold and prescribed as a subcutaneous injection (see below for more context).

The Study is ongoing and additional results are expected soon.

About Liraglutide
Liraglutide is owned by Novo Nordisk® and sold under the Victoza® and Saxena® brands which generated $1.6 billion in combined revenue in 2022. Liraglutide is currently administered only by injection, after attempts to utilize the sodium salcaprozate ("SNAC") technology found in semaglutide (and sold as the oral tablet Rybelsus®) failed to deliver sufficient performance to enable an oral form factor.

Previous investigators reported that "the absorption enhancing action of SNAC is thought to be highly dependent on the specific agent it is enhancing, which means that carefully tailored co-formulation is required rather than co-administration. The structure of liraglutide (a structurally distinct analog of GLP-1RA) was found to be unfavorable for co-formulation with SNAC on account of its stronger membrane-binding properties, which reduced transcellular passage, as well as its greater tendency to oligomerize, which countered the monomerizing effects of SNAC. In a preclinical study, plasma exposure was significantly higher for semaglutide than liraglutide after oral dosing 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 be dosed for a 12-week period following the initial acclimation period. During the Study, over 1,500 blood plasma samples will be collected from the total rat population of 72 animals for purposes of detailed PK drug delivery analyses. Because of the small animal population in each Study arm, statistical significance is not expected and instead, commentary on apparent trends has been noted. Body weight and blood glucose readings were taken prior to Study start continuing at regular intervals during and at conclusion of the dosing period. Upon completion of the Study, brain tissue will be analysed to help determine whether DehydraTECH processing results in higher brain absorption than non-DehydraTECH arms, as Lexaria has evidenced numerous times in previous similar animal studies. The Study will also include a comprehensive battery of liver and kidney function testing and blood chemistry analyses. LC-MS/MS and other techniques will be used to analyse samples. All animal groups are offered unlimited access to food throughout the Study.

About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 46 patents granted and many patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS
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 are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated 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 contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements or links to third-party websites contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View the original press release on accesswire.com

FAQ

What were the key findings of Lexaria's WEIGHT-A24-1 animal study for diabetes?

The study showed that DehydraTECH-liraglutide and two DehydraTECH-CBD formulations were the top performers, with blood sugar level reductions of 2.50%, 1.90%, and 1.53% respectively at day 56. All active treatment groups showed improved blood sugar control compared to the obese control group from a previous study.

How did DehydraTECH-liraglutide compare to DehydraTECH-semaglutide in Lexaria's LEXX study?

DehydraTECH-liraglutide outperformed DehydraTECH-semaglutide in blood sugar control. This is notable because in human studies without DehydraTECH processing, semaglutide typically outperforms liraglutide.

What potential does DehydraTECH-CBD show for diabetes treatment based on Lexaria's LEXX study results?

The study results suggest that DehydraTECH-CBD may have utility in diabetic control, especially if used in combination with a GLP-1 drug. Two DehydraTECH-CBD formulations showed significant blood sugar level reductions of 1.90% and 1.53% at day 56.

When are additional results expected from Lexaria's WEIGHT-A24-1 diabetes study for LEXX stock?

The study is ongoing, and Lexaria Bioscience Corp. (NASDAQ:LEXX) has stated that additional results are expected soon. The company is currently in the final phases of testing combination DehydraTECH-CBD with DehydraTECH-GLP-1 drugs.

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