Lexaria Bioscience Corp. (NASDAQ:LEXX) on Tuesday provided an update on its Phase 1b, 12-week chronic study GLP-1-H24-4, recently completed in Australia, focusing on 4 DehydraTECH ( DHT) study arms relative to the Novo Nordisk A/S‘ (NYSE:NVO) Rybelsus (semaglutide) control study arm.
“We are extremely pleased to not only have successfully achieved our primary endpoint,” stated Richard Christopher, CEO of Lexaria, “but to have also demonstrated obvious superiority in reducing unwanted side effects by as much as approximately half as compared to the world’s only approved oral-based GLP-1 medication, Rybelsus.
After the full 12 weeks of treatment, followed by a 4-week follow-up period (16-week study duration overall), all 4 DHT test articles appeared to be safe and well tolerated, thus meeting the primary endpoint objective of the study.
Each of the DHT arms had lower rates of overall treatment-emergent adverse events (AE) and gastrointestinal AEs compared to the Rybelsus control arm.
Of the DHT formulations evaluated, DehydraTECH-semaglutide (DHT-semaglutide) was the top performer in total AE reductions.
There was a 47.9% reduction in the total quantity of AEs derived from DHT-semaglutide vs. Rybelsus.
There was also a statistically significant 54.9% reduction in GI AEs from DHT-semaglutide vs. Rybelsus.
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For the primary efficacy endpoint of HbA1c reduction, the percent reduction achieved was comparable between DHT-semaglutide and Rybelsus arms.
Bodyweight reduction performance, however, improved in the Rybelsus control arm compared with all DHT arms at both the week 12 and week 16 evaluations, as previously observed at the 8-week interim analysis.
Next Steps
Lexaria believes its DHT-semaglutide formulation warrants further development for the indication evaluated.
The company believes future work should incorporate salcaprozate sodium (SNAC), which was included in Lexaria’s earlier human studies (GLP-1-H24-1 and GLP-1-H24-2) but not in the current study.
Lexaria is evaluating options to conduct follow-on human clinical testing of a DehydraTECH + SNAC + semaglutide formulation versus Rybelsus.
Any such study would build on the combined findings from studies GLP-1-H24-1, GLP-1-H24-2, and GLP-1-H24-4. The company will provide additional details once plans are finalized.
Separately, following the public release of the final results from GLP-1-H24-4, Lexaria will provide the full dataset to the pharmaceutical company with which it has a Material Transfer Agreement (MTA), which was extended through April 30, 2026, to allow sufficient time for data review; further updates are expected.
Price Action: LEXX stock is down 7.42% at $0.63 at the last check on Tuesday.
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