First Results from Lexaria's Second GLP-1 Human Pilot Study

Rhea-AI Summary

Lexaria Bioscience Corp. (NASDAQ:LEXX) has announced initial results from its second GLP-1 human pilot study, GLP-1-H24-2. The study compared DehydraTECH-processed Rybelsus to standard Rybelsus under fed conditions. Key findings include:

1. DehydraTECH-processed Rybelsus showed 18.8% higher average semaglutide levels over 24 hours.

2. Higher semaglutide levels were observed in 17 out of 19 blood draws.

3. The study used 7 mg semaglutide doses in both arms.

4. Results were not statistically significant due to small sample size.

These findings complement an earlier study showing a 43% peak blood level improvement under fasted conditions. Lexaria plans to continue its 2024 GLP-1 program with ongoing animal studies and a planned 12-week chronic human study.

Positive

• DehydraTECH-processed Rybelsus showed 18.8% higher average semaglutide levels over 24 hours
• Higher semaglutide levels were observed in 17 out of 19 blood draws
• DehydraTECH appears to offer pharmacokinetic improvements even under fed conditions
• Previous study showed 43% peak blood level improvement under fasted conditions

Negative

• Results were not statistically significant due to small sample size

Insights

Financial Analyst

The first results from Lexaria's second GLP-1 human pilot study show a trend towards higher overall absorption of DehydraTECH-processed Rybelsus® under fed conditions. While the 18.8% average increase in semaglutide levels is promising, it's important to note that the results were not statistically significant due to the small sample size. This data, combined with the previous study showing a 43% peak blood level improvement in fasted conditions, suggests potential for DehydraTECH to enhance drug delivery. However, investors should remain cautious as larger, more robust studies are needed to confirm these findings. The planned 12-week chronic human study will be important in determining the long-term viability and market potential of Lexaria's technology in the competitive GLP-1 space.

Medical Research Analyst

Lexaria's study results are intriguing from a drug delivery perspective. The DehydraTECH-processed Rybelsus® showed higher semaglutide levels in 17 out of 19 blood draws, averaging 18.8% higher over 24 hours compared to standard Rybelsus®. This is particularly interesting given that the study was conducted under fed conditions, which typically reduce Rybelsus® absorption. The consistency of improved absorption across multiple time points suggests DehydraTECH may offer a more stable delivery profile. However, the lack of statistical significance and small sample size means these results should be viewed as preliminary. The upcoming 12-week chronic study will be critical in assessing whether these pharmacokinetic improvements translate to enhanced efficacy or reduced side effects, which could potentially differentiate Lexaria's technology in the rapidly growing GLP-1 market.

Market Research Analyst

Lexaria's latest study results could have significant implications for the GLP-1 market, which is projected to reach $150 billion by 2031. The trend towards improved absorption of DehydraTECH-processed Rybelsus®, even under fed conditions, could address a key limitation of current GLP-1 drugs. If further validated, this technology could potentially allow for more flexible dosing regimens, improving patient compliance and quality of life. However, it's important to note that giants like Novo Nordisk dominate this space and Lexaria faces significant competition and regulatory hurdles. The company's market capitalization of around $20 million suggests investors are cautious. While these results are promising, Lexaria needs to demonstrate clear clinical benefits and secure partnerships to gain a foothold in this lucrative but challenging market.

Trend toward higher overall absorption under fed conditions evidenced with DehydraTECH^®-processed Rybelsus^®

KELOWNA, BC / ACCESSWIRE / August 27, 2024 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that the first results from human pilot study #2, GLP-1-H24-2 (the "Study"), have been received. Lexaria's DehydraTECH^®-processed Rybelsus^® evidenced a trend toward higher overall absorption compared to Rybelsus^® that was not processed with DehydraTECH.

Since Lexaria has already demonstrated superior pharmacokinetic performance of its DehydraTECH-processed Rybelsus^® under the recommended dosing conditions on an empty stomach in previously announced human pilot study #1, GLP-1-H24-1, it was deemed to be of scientific interest to learn whether the DehydraTECH advantages were also experienced under fed conditions. The DehydraTECH-processed Rybelsus^® evidenced higher semaglutide levels in 17 of the 19 blood draws taken until the 24-hour completion of the study averaging 18.8% higher semaglutide levels over the course of the study compared to Rybelsus^® alone, although the differences were variable and not significant statistically with such a small sample size.

The two arms of the Study being reported today compared equal 7 mg semaglutide doses from a Rybelsus^® swallowed tablet versus a DehydraTECH-processed Rybelsus^® swallowed capsule. The volunteers in this Study were administered the drugs while they were in a "fed" state, as compared to an earlier study that demonstrated a 43% peak blood level improvement wherein the volunteers were administered the drug in a "fasted" state. It should be noted that Novo Nordisk™, the owner and manufacturer of Rybelsus^®, recommends taking Rybelsus^® on an empty stomach, because studies have shown that Rybelsus administration under fed conditions leads to decreased systemic absorption. Their label reads, "Take RYBELSUS^® by mouth on an empty stomach when you first wake up with a sip of plain water (no more than 4 ounces)."

Semaglutide Absorption (nmol/l)

Time (minutes)	Rybelsus®	DehydraTECH Rybelsus®	Difference (%)
0	0.00	0.00	N/A
20	0.00	0.48	N/A
40	0.36	1.06	196.9%
60	1.24	1.63	31.3%
80	1.70	2.12	24.8%
100	2.54	2.60	2.2%
120	3.13	3.12	-0.4%
140	3.50	3.80	8.6%
160	3.86	4.13	7.2%
180	4.27	4.49	5.2%
210	4.64	4.98	7.2%
240	5.02	5.47	8.8%
300	5.64	6.23	10.4%
360	6.21	6.67	7.3%
420	6.64	6.97	4.8%
480	7.12	7.20	1.1%
540	7.39	7.39	0.0%
600	7.61	7.61	0.0%
24 Hrs	3.77	3.92	4.1%
Average	3.93	4.20	18.8%

"Lexaria is delighted that our contracted clinical research organization was able to complete the active phase of the Study on schedule," said Chris Bunka, Chief Executive Officer of the Company. "The results of these Study arms have shown that DehydraTECH appears to continue to offer pharmacokinetic improvements even when dosed under fed conditions, reinforcing DehydraTECH's beneficial delivery kinetics."

Next steps moving forward in Lexaria's 2024 GLP-1 experimental program will include finalization of our ongoing animal study, which has already produced positive results as previously announced, and continued progress toward initiation of our planned upcoming 12-week chronic human study, which will be conducted under fasted dosing conditions. Data from the tolerability evaluations and the mouth melt absorption Study arm will also be available soon.

About the Study

Design characteristics of the Study are comparable to Lexaria's initial human pilot study. The DehydraTECH-semaglutide test articles were compound formulated using crushed Rybelsus® tablets strictly for research purposes. The Study is designed to measure tolerability and side effects, blood levels of semaglutide, blood glucose and insulin levels. Blood samples were taken multiple times during the first 10 hours post dosing; a final blood draw was taken 24 hours after dosing; and a standardized meal was allowed pre-dosing and fed to the test subjects at a point in time after dosing. Nine healthy subjects were dosed in each of the first two study arms, and seven were dosed in the final study arm.

About Semaglutide

Rybelsus^® (semaglutide) is the only GLP-1 drug approved by the FDA for oral dosing to treat diabetes and weight loss. The FDA has also approved semaglutide marketed as Ozempic^® and Wegovy^®, administered by injection, to treat diabetes and weight loss. All three of these drugs are owned and manufactured by Novo Nordisk^®.

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 second GLP-1 human pilot study (GLP-1-H24-2) for LEXX stock?

The study showed that DehydraTECH-processed Rybelsus had 18.8% higher average semaglutide levels over 24 hours compared to standard Rybelsus under fed conditions. Higher levels were observed in 17 out of 19 blood draws, although results were not statistically significant due to small sample size.

How does the recent study of DehydraTECH-processed Rybelsus compare to Lexaria's previous study for LEXX?

The recent study showed an 18.8% higher average semaglutide level under fed conditions, while a previous study demonstrated a 43% peak blood level improvement under fasted conditions for DehydraTECH-processed Rybelsus.

What are Lexaria's (LEXX) next steps in their 2024 GLP-1 experimental program?

Lexaria plans to finalize ongoing animal studies, which have already produced positive results, and progress toward initiating a planned 12-week chronic human study under fasted dosing conditions.

What was the dosage used in Lexaria's second GLP-1 human pilot study for LEXX stock?

The study compared equal 7 mg semaglutide doses from a standard Rybelsus swallowed tablet versus a DehydraTECH-processed Rybelsus swallowed capsule.