Healthcare

Lexaria Reports Animal Study Results, Including 566% Brain Absorption Improvement

Lexaria Bioscience reported results from animal study GLP-1-A26-1, which evaluated DehydraTECH-CBD and DehydraTECH-semaglutide formulations and included a reported 566% improvement in mean brain absorption for one DHT-CBD formulation.

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Lexaria Bioscience Corp. (NASDAQ:LEXX) has reported results from animal study GLP-1-A26-1, which assessed alternative DehydraTECH-CBD and DehydraTECH-semaglutide formulations. The company said one DHT-CBD formulation produced a 566% improvement in mean brain absorption compared with a historical reference formulation 8 hours after dosing.

#Study findings for DHT-CBD

The DHT-CBD ALT1 study arm recorded stronger blood-plasma absorption than the historical formulation used as the REF arm. ALT2 and ALT3 also showed strong blood-plasma performance, although their results were below those of ALT1 and REF.

Lexaria said none of the DHT-CBD alternative arms had blood-plasma absorption levels that were statistically significantly different from REF at p<0.05. The company said this meant each alternative could potentially be considered for further development and commercialisation in place of the tested reference formulation.

All 3 DHT-CBD alternatives produced higher brain-tissue absorption than REF. The company identified DHT-CBD ALT2 as the strongest result, reporting a 566% improvement in mean brain absorption against REF 8 hours after dosing. Lexaria said the finding was greater than expected and required further investigation.

#DHT-semaglutide results

Among the DHT-SEMA study arms, ALT2 delivered the highest blood-plasma absorption. However, Lexaria said its absorption level was not statistically significantly different from REF at p<0.05.

Measurements of DHT-SEMA in brain tissue were below the lower limit of quantitation for the bioassay used in the study, making those results non-reportable. Lexaria noted that an earlier brain biodistribution study had used a more sensitive fluorescently tagged semaglutide detection method, which was not practical for this study.

The company also said the ingredients in some ALT1, ALT2 and ALT3 formulations differed between the DHT-CBD and DHT-SEMA testing. The same labels were used for formulation strategies tailored to the separate active pharmaceutical ingredients.

#Patent applications and SNAC research

Lexaria said it had filed 3 new patent applications relating to formulations evaluated in the study. Because the applications had not been published, the company is not disclosing the full details of the formulations or all outcomes.

The study also examined alternative formulations to SNAC, or salcaprozate sodium. Lexaria said SNAC is used by Novo® with its oral Rybelsus® and Wegovy® tablet products. The company is investigating DehydraTECH-compatible formulations that could deliver performance similar to or greater than SNAC while supporting new proprietary intellectual property.

#Study design

The research used Sprague-Dawley rats across 11 separate study arms. It compared novel DHT-CBD and DHT-SEMA formulations with selected historical DHT formulations, as well as intravenously administered non-DHT CBD and semaglutide preparations.

Blood samples were collected at multiple points during an 8-24 hour post-dosing period to assess pharmacokinetic performance. The study also measured drug concentrations in brain tissue.

#Company comments and limitations

Rich Christopher, Lexaria’s CEO, said certain formulations achieved the company’s highest-ever DehydraTECH pharmaceutical-grade relative absorption performance. He said the company believes the formulation changes should support greater performance in the future and help it remain ahead of competitive oral delivery developments in 2027 and beyond.

Lexaria described the work as investigatory animal research. The company said it would consider how to use the findings and related intellectual property and investigate whether the formulation enhancements could be applied to other drug categories.

The company cautioned that its forward-looking statements involve risks including regulatory approvals, scientific discovery, the patent application and approval process, potential adverse effects from testing or using products based on DehydraTECH, competition and delays or cancellations affecting research and development. Lexaria also said there is no assurance that the proposed uses, benefits or advantages of its technology will be realised. The statements in the announcement had not been evaluated by the US Food and Drug Administration.

#Key Takeaways

  • Lexaria reported results from animal study GLP-1-A26-1 involving DHT-CBD and DHT-SEMA formulations.
  • DHT-CBD ALT2 showed a 566% improvement in mean brain absorption compared with REF 8 hours after dosing.
  • All 3 DHT-CBD alternatives produced higher brain absorption than REF, while none differed statistically significantly from REF in blood-plasma absorption at p<0.05.
  • DHT-SEMA brain-tissue concentrations were below the lower limit of quantitation and were non-reportable.
  • Lexaria said it had filed 3 new, unpublished patent applications linked to the tested formulations.

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