Lexaria Bioscience Corp. (NASDAQ:LEXX) announced positive findings from its Phase 1b clinical study GLP-1-H24-4, a 12-week chronic trial focusing on its DehydraTECH™ (DHT) delivery platform in comparison to the Rybelsus® control arm.
The study, recently completed in Australia, explored four DHT arms and examined secondary efficacy, body composition, blood pressure, and pharmacokinetic parameters, providing crucial insights that may guide future research and development efforts.
Richard Christopher, CEO of Lexaria, expressed enthusiasm about the results, noting, "This adds to a growing dataset that highlights the potential benefits of our DehydraTECH platform. Clinical data is essential at this stage, and we are excited for the directions our research is taking into 2026 and beyond."
At the 16-week mark, there were no significant differences in mean fasting glucose, cholesterol, and LDL cholesterol between the DHT arms and the Rybelsus® control group.
In terms of body composition, the DHT-semaglutide group showed a modest reduction in fat mass (-1.08 kg) and total mass (-1.40 kg), with minimal reduction in lean mass (-0.41 kg), compared to more significant reductions in the Rybelsus® group.
The study also observed that the DHT-CBD arm, which was not designed as an efficacy endpoint, achieved notable reductions in blood pressure, which was of particular interest given the participants were not required to be hypertensive.
At week 4, systolic blood pressure decreased by -4.6 mmHg and diastolic blood pressure by -4.0 mmHg, with continued reductions observed at the week 16 follow-up.
In pharmacokinetic analyses, plasma levels of CBD and semaglutide were quantifiable in DHT arms, though plasma semaglutide levels were not detectable due to unforeseen assay issues.
Follow-up tests are underway to resolve this discrepancy.
Participants in the DHT-semaglutide arm reported greater improvements in physical and mental health components in the Short Form 36 Health Survey (SF-36), compared to those in the Rybelsus® arm.
This aligns with earlier findings of reduced adverse events in the DHT arms.
Following the successful completion of GLP-1-H24-4, Lexaria is contemplating additional human clinical studies, potentially incorporating the salcaprozate sodium (SNAC) ingredient, which showed superior efficacy in earlier studies.
The company is also set to share the full 7,000-page dataset with a pharmaceutical partner under an extended Material Transfer Agreement (MTA), which will help shape Lexaria's future strategy.
The company is optimistic about the potential for DHT-CBD to address hypertension, with an FDA-approved Phase 1b study underway.
Meanwhile, Lexaria continues to explore new financing opportunities to fund its research and development, aiming to push forward with plans into 2026.