Lexaria Provides Positive Interim Results on Partial 8-week Data from Phase 1b, GLP-1-H24-4 Study

Rhea-AI Summary

Lexaria Bioscience (NASDAQ:LEXX) has reported positive interim 8-week results from its Phase 1b GLP-1-H24-4 study comparing DehydraTECH-enhanced semaglutide and tirzepatide to Rybelsus®. The study revealed that DehydraTECH-semaglutide reduced overall adverse events by 36.5% and gastrointestinal side effects by 43.5% compared to Rybelsus®.

Key findings show that only 79.2% of DehydraTECH-semaglutide patients experienced adverse events, compared to 100% in the Rybelsus® group. For weight loss, DehydraTECH-semaglutide showed a reduction of 1.23% after 8 weeks, while HbA1c levels decreased by 0.14%. The study is expected to complete with final results by the end of 2025.

Positive

• DehydraTECH-semaglutide reduced total adverse events by 36.5% compared to Rybelsus®
• 43.5% reduction in gastrointestinal adverse events with DehydraTECH-semaglutide vs Rybelsus®
• 20.8% fewer patients experienced adverse events with DehydraTECH-semaglutide compared to Rybelsus®
• DehydraTECH-tirzepatide showed only 22% GI-related adverse events vs 40-50% in injectable tirzepatide studies

Negative

• Weight loss with DehydraTECH-semaglutide (1.23%) was lower than Rybelsus® (4.23%) at 8 weeks
• HbA1c reduction with DehydraTECH-semaglutide (0.14%) was less than Rybelsus® (0.25%) at 8 weeks
• DehydraTECH-tirzepatide showed minimal impact on weight (+0.28%) and HbA1c (+0.01%) at 8 weeks

Insights

Pharmaceutical R&D Analyst

DehydraTECH reduced GLP-1 side effects by 36.5% vs Rybelsus in Phase 1b interim results, potentially improving patient compliance.

Lexaria's 8-week interim results from its Phase 1b GLP-1-H24-4 trial demonstrate promising safety advantages for its DehydraTECH (DHT) drug delivery platform when combined with semaglutide. The data shows a 36.5% reduction in overall adverse events and a 43.5% reduction in gastrointestinal side effects compared to Rybelsus (oral semaglutide from Novo Nordisk).

This reduction in side effects is particularly significant for GLP-1 medications, as gastrointestinal issues like nausea, vomiting, and diarrhea are major reasons for treatment discontinuation. The study showed that while 100% of Rybelsus patients experienced at least one adverse event, only 79.2% of DHT-semaglutide patients had similar experiences. This 20.8% reduction could substantially improve medication adherence if maintained in larger studies.

For efficacy measurements, DHT-semaglutide showed weight loss of 1.23% (vs. 4.23% for Rybelsus) and HbA1c reduction of 0.14% (vs. 0.25% for Rybelsus) at 8 weeks. These efficacy results appear lower than the control arm, though the company notes Rybelsus performance in their study appears anomalously strong compared to historical data. The DHT-tirzepatide arm showed minimal impact on weight (+0.28%) and HbA1c (+0.01%) at this interim point.

This data represents a critical proof-of-concept for Lexaria's DehydraTECH platform, suggesting it may improve tolerability of GLP-1 medications without sacrificing efficacy, though complete 12-week data will provide a clearer picture. The technology could potentially address a significant unmet need in the rapidly growing GLP-1 market by improving patient compliance through reduced side effects.

• DehydraTECH-semaglutide reduces overall side effects by 36.5% as compared to Rybelsus®

• DehydraTECH-semaglutide reduces gastrointestinal side effects by 43.5% as compared to Rybelsus®

• DehydraTECH-GLP-1 study arms evidencing patient safety and tolerability consistent with the primary study endpoint

KELOWNA, BC / ACCESS Newswire / July 28, 2025 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, provides the following partial 8-week positive interim results update on the phase 1b, 12-week chronic study GLP-1-H24-4 (the "Study" or the "Lexaria Study"), currently underway in Australia, focusing on the DehydraTECH ("DHT") glucagon-like peptide-1 ("GLP-1") study arms 2 and 5 relative to the Rybelsus® control study arm 4.

"We are extremely encouraged by the interim results received to date aligned with our primary study endpoint," said Richard Christopher, CEO of Lexaria. "DehydraTECH is continuing to demonstrate obvious superiority in reducing unwanted side effects compared to the world's only approved oral-based GLP-1 medication, Rybelsus®."

Adverse Events

After 8 weeks of treatment, Lexaria's DehydraTECH-GLP-1 arms are tracking very nicely from a safety and tolerability perspective relative to the Rybelsus® control arm; most notably in terms of reductions in the incidence of gastrointestinal ("GI") adverse events ("AEs"):

GLP-1-H24-8-week Interim Results (Oral formulations)	DHT-semaglutide 3.5 mg x 4 weeks followed by 7 mg x 4 weeks (Arm 2; n=24)	Rybelsus® 3 mg x 4 weeks followed by 7 mg x 4 weeks (Arm 4; n = 25) (Study Control Arm)	DHT-tirzepatide 20 mg x 4 weeks followed by 40 mg x 4 weeks (Arm 5; n=25)
Persons with at least 1 AE	79.2%	100%	72.0%
Total AEs	61	96	90
Total AEs as a % of Control	63.5%	N/A	93.8%
Total GI AEs	26	46	20
Total GI AEs as a % of Control	56.5%	N/A	43.5%
Nausea	8	18	2
Vomiting	1	3	0
Diarrhea	5	6	9
All other GI AEs	12	19	9

n = number of patients included in each study group for safety and tolerability assessments

Of note, every person taking Rybelsus® in the Study experienced at least one AE. There was a 20.8% reduction in the overall number of persons experiencing an AE with DehydraTECH-semaglutide ("DHT-semaglutide") vs. Rybelsus® and a 36.5% reduction in the total quantity of AEs derived from DHT-semaglutide vs. Rybelsus®. There was also a 43.5% reduction in GI AEs from persons taking DHT-semaglutide vs. Rybelsus®.

In Novo Nordisk's® Semaglutide Treatment Effect in People with obesity (STEP) studies, across a patient population of 3,331 people, 2,934 or 88.1% of them experienced AEs of any kind. Through 8 weeks, only 79.2% of patients in the DHT-semaglutide study arm have experienced AEs of any kind, meaning 10.1% fewer patients in the DHT-semaglutide study arm experienced AEs relatively speaking. Potentially removing all AEs from 10% of a patient population that is currently millions of people, could provide immense relief for many and encourage more people to continue on their treatment protocol without premature discontinuation as is often a challenge commercially today due to unwanted AEs.

It is difficult to compare the DehydraTECH-tirzepatide ("DHT-tirzepatide") AEs to any benchmark because there is no commercially available orally-dosed tirzepatide sold today, as tirzepatide is sold by Eli Lilly only in injectable formats. A meta-analysis reviewing 10 different injected tirzepatide trials involving 6,836 patients found broadly similar incidences of AEs as did the Lexaria Study examining orally dosed DHT-tirzepatide, but that meta-analysis noted that 40% to 50% of injected tirzepatide AEs were GI-related, whereas for the DHT-tirzepatide study arm that proportion of GI-related AEs through 8 weeks is much lower at 22%. This could potentially signify that oral DHT-tirzepatide might reduce AEs by as much as half, compared to the injectable tirzepatide that was evaluated in those earlier studies.

HbA1c and Bodyweight

Assessments of the magnitude of decreases in glycated haemoglobin ("HbA1c"), as a primary blood test for blood sugar levels, and body weight are the major efficacy endpoints of the Study.

For comparison purposes, in Novo Nordisk's® Pioneer 1 phase 3a randomized study conducted in 703 patients with type 2 diabetes, daily doses of Rybelsus® semaglutide were administered at varying dose levels, and, after 26 weeks of dosing, the average changes in HbA1c levels and body weight were reported as follows:

Pioneer 1: 26-Week Final Results	3 mg Rybelsus®	7 mg Rybelsus®	14 mg Rybelsus®
Body Weight Baseline = 88.1kg	-1.32 kg or -1.5%	-2.02 kg or -2.3%	-3.26 kg or -3.7%
HbA1c	-0.9%	-1.2%	-1.4%

Further, Novo Nordisk's® Pioneer 6 phase 3a randomized study conducted in 1,591 patients received daily doses of Rybelsus® administered at 3 mg for the first 4 weeks; 7 mg for the next 4 weeks; and 14 mg thereafter until the conclusion of the study. As such the Pioneer 6 study utilized a dose escalation strategy nearly identical to the Lexaria Study for the first 8 weeks thereof at least, with average results shown in the table below:

Pioneer 6: 8-Week Approximate ** Interim Results	Rybelsus® 3 mg x 4 weeks followed by 7 mg x 4 weeks
Body Weight Baseline = 91.0 kg	-1.70 kg or 1.9%
HbA1c	-0.825%

**8-week results from Pioneer 6 study have been extrapolated from the study appendix

In the context of this press release it is very important to remember that Lexaria is, today, only reporting interim average 8-week results which is clearly a small fraction of the time studied relative to the above noted Pioneer 1, 26-week study, therefore making Lexaria's Study results more relatable to the Pioneer 6, 8-week study interim results data:

GLP-1-H24-4 8-week Interim Results	DHT-semaglutide 3.5 mg x 4 weeks followed by 7 mg x 4 weeks (Arm 2; n=23)	Rybelsus® 3 mg x 4 weeks followed by 7 mg x 4 weeks (Arm 4; n=25) (Study Control Arm)	DHT-tirzepatide 20 mg x 4 weeks followed by 40 mg x 4 weeks (Arm 5; n=24)
Body Weight	-1.14 kg or -1.23% (range -6.6 to + 4.6 Kg)	-4.14 kg or -4.23% (range -8.9 to +0.0 Kg)	+0.28 kg or +0.28% (range -8.0 to +7.0 Kg)
HbA1c	-0.14% (range -0.5 to +0.3%)	-0.25% (range -0.6 to +0.5%)	+0.01% (range -0.5 to +0.5%)

n = number of patients included in each study group for HbA1c and body weight efficacy assessments

Lexaria's average DHT-semaglutide weight loss results after 8 weeks are tracking similar to the historical performance of Rybelsus® in the much larger Pioneer studies, which is thus far encouraging to see.

Curiously, the Rybelsus® body weight performance data in the current Lexaria Study appears to be much stronger than the results shown above in both the 26-week Pioneer 1 study and in the Pioneer 6, 8-week interim data. The reasons for this apparent anomaly are presently unknown, but likely related to the small sample size of the Lexaria Study. The historical studies conducted in thousands of persons are more likely to be representative of real-world performance.

For HbA1c levels it is important to understand that HbA1c measures blood glucose over a 8-12 week period of time, thus the current 8-week data from Lexaria's Study is barely relevant compared to expected 12-week data. Furthermore, there is no statistically significant difference between the DHT-semaglutide and Rybelsus® reductions in HbA1c witnessed at the 8-week point thus far in the Study (p=0.069). The 12-week HbA1c data should be more representative, and potentially, quite different from the 8-week data.

Additional 8-week interim Study data may or may not be released as it is more fully processed and understood in the weeks to come. The vast majority of laboratory-derived data, including a battery of additional safety, tolerability and efficacy parameter assessments beyond those summarized here, and all final results will not be available until near the end of calendar-2025. The Study is currently approaching the "last patient last visit" milestone and remains on schedule.

About Lexaria Bioscience Corp. & DehydraTECH

DehydraTECH™ is Lexaria's patented drug delivery formulation and processing platform technology which improves the way a wide variety of drugs enter the bloodstream, always through oral delivery. DehydraTECH has repeatedly evidenced the ability to increase bio-absorption, reduce side-effects, and deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 50 patents granted and additional 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 to 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 ACCESS Newswire

FAQ

What are the key findings from Lexaria's (LEXX) Phase 1b GLP-1 trial interim results?

The trial showed DehydraTECH-semaglutide reduced overall adverse events by 36.5% and gastrointestinal side effects by 43.5% compared to Rybelsus®. Only 79.2% of patients experienced adverse events versus 100% in the Rybelsus® group.

How does DehydraTECH-semaglutide's weight loss compare to Rybelsus® in the LEXX study?

After 8 weeks, DehydraTECH-semaglutide showed 1.23% weight loss compared to 4.23% with Rybelsus®, though the small sample size may not represent real-world performance.

What is the difference in HbA1c reduction between DehydraTECH-semaglutide and Rybelsus®?

DehydraTECH-semaglutide showed a 0.14% HbA1c reduction compared to 0.25% with Rybelsus®, though these 8-week results are preliminary as HbA1c measures glucose over 8-12 weeks.

When will Lexaria's (LEXX) final GLP-1 study results be available?

The final results, including additional safety, tolerability, and efficacy parameters, are expected to be available by the end of 2025.

How does DehydraTECH-tirzepatide compare to injectable tirzepatide in terms of side effects?

DehydraTECH-tirzepatide showed only 22% GI-related adverse events compared to 40-50% reported in injectable tirzepatide studies, potentially indicating a reduction in side effects by half.