08/21/2024 | Press release | Distributed by Public on 08/21/2024 07:03
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 |
26.4 |
25.5 |
-3.60 |
26.8 |
1.33 |
F: Rybelsus2 |
24.9 |
26.8 |
7.70 |
26.4 |
5.96 |
G: Semaglutide |
26.3 |
25.9 |
-1.52 |
27.8 |
5.54 |
H: Liraglutide |
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
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INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202
SOURCE: Lexaria Bioscience Corp.
Released August 21, 2024