Lexaria Bioscience Announces Results From Animal Study GLP-1-A26-1 Evaluating Both DehydraTECH-CBD Compositions And DehydraTECH-Semaglutide; Unfortunately, The DHT-SEMA Concentrations In Brain Tissue Were All At Levels Below The Lower Limit Of Quantitation Of The Bioassay Utilized In This Study
Lexaria Bioscience Corp. (NASDAQ:LEXX) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to provide the following results from animal study GLP-1-A26-1 (the "Study") that evaluated a number of formulation enhancements using both DehydraTECH-CBD ("DHT-CBD") compositions and DehydraTECH-semaglutide ("DHT-SEMA") glucagon-like peptide-1 ("GLP-1") compositions to explore the potential for additional improved performance, as well as stake new intellectual property ("IP") claims.
Lexaria has already filed 3 new patent applications related to the formulations evaluated in this Study to protect this new IP. As these patent applications are not yet published, we will not be providing full details of all the specific formulations or outcomes at this time.
"We are delighted that certain new formulations in this Study achieved our highest-ever DehydraTECH pharmaceutical-grade relative absorption performance," said Rich Christopher, CEO of Lexaria Bioscience Corp. "These new formulation enhancements should enable Lexaria to achieve even greater performance in the future and help us to stay ahead of competitive oral delivery developments in 2027 and beyond."
DHT-CBD Blood Plasma Results:
The DHT-CBD (ALT1) Study arm provided superior absorption into blood plasma as compared to one of Lexaria's best, pharmaceutical-grade, historical formulations which was used as the reference ("REF") Study arm. In addition, the DHT-CBD (ALT2) and DHT-CBD (ALT3) Study arms also provided strong blood plasma absorption performance albeit lower than both DHT-CBD (ALT1) and REF Study arms. Of note, none of the DHT-CBD ALT Study arms demonstrated statistically significantly (p<0.05) different blood plasma absorption levels from the REF Study arm indicating that any and all of the DHT-CBD ALT Study arm compositions could potentially be viable candidates for future development and commercialization pursuits in place of the REF composition tested.
Treatment
Arm Cmax/D
(ng/mL)/(mg/kg)
mean ± SD AUClast/D
(h*ng/mL)/(mg/kg)
mean ± SD
DHT-CBD (REF) 8.65 ± 4.42 31.2 ± 18.5
DHT-CBD (ALT1) 9.30 ± 3.92 34.5 ± 16.3
DHT-CBD (ALT2) 3.74 ± 1.18 19.5 ± 4.03
DHT-CBD (ALT3) 6.28 ± 2.49 28.4 ± 8.87
Cmax/D refers to the dose-adjusted peak blood plasma drug concentration.
AUClast/D refers to the dose-adjusted total drug exposure up to the last measured timepoint in the Study.
DHT-CBD Brain Tissue Results:
Each of the 3 Study arms DHT-CBD (ALT1), DHT-CBD (ALT2), and DHT-CBD (ALT3), delivered superior absorption into brain tissue as compared to the same historical formulation used as the REF. Further, DHT-CBD (ALT2) evidenced a massive 566% improvement in mean brain absorption as compared to the REF arm 8 hours after dosing. This relative increase in brain absorption is greater than what we expected and is worthy of additional investigation. Distribution of specific drugs into brain tissue can empower dramatic improvements of that drug's overall effectiveness.
Treatment
Arm CBD in brain homogenate 8 hours post-dose (ng/g)
mean ± SD CBD in brain homogenate 24 hours post-dose (ng/g)
mean ± SD
DHT-CBD (REF) 9.42 ± 1.91 0.00 ± 0.00
DHT-CBD (ALT1) 11.6 ± 4.09 0.00 ± 0.00
DHT-CBD (ALT2) 62.8 ± 34.3 3.55 ± 3.28
DHT-CBD (ALT3) 38.7 ± 17.7 0.00 ± 0.00
DHT-SEMA Blood Plasma Results:
For the DHT-SEMA Study arms, DHT-SEMA (ALT2) was the highest performer, also without any statistically significantly (p<0.05) different blood plasma absorption levels from the REF Study arm, indicating it too could potentially be a viable candidate for future development and commercialization pursuits in place of the REF composition.
It is also important to note that there were some ingredient differences comparing certain of the ALT1, ALT2, and ALT3 formulations used in the DHT-SEMA Study arms versus the DHT-CBD Study arms despite use of the same ALT nomenclature in both cases. This was because Lexaria tested certain prospective formulation enhancement strategies in each case that were tailored to the very different active pharmaceutical ingredients of CBD versus SEMA.
Treatment
Arm Cmax/D
(ng/mL)/(mg/kg)
mean ± SD AUClast/D
(h*ng/mL)/(mg/kg)
mean ± SD
DHT-SEMA (REF) 88.7 ± 52.4 270 ± 170
DHT-SEMA (ALT1) 14.0 ± 16.3 44.6 ± 69.3
DHT-SEMA (ALT2) 58.8 ± 77.2 153 ± 189
DHT-SEMA (ALT3) 32.7 ± 25.8 96.3 ± 77.2
DHT-SEMA Brain Tissue Results:
Unfortunately, the DHT-SEMA concentrations in brain tissue were all at levels below the lower limit of quantitation of the bioassay utilized in this Study and, therefore, non-reportable. By comparison, in Lexaria's previous brain biodistribution study, a predominantly higher apparent trend in brain biodistribution was evidenced with a specific DHT-SEMA composition compared to a Rybelsus® equivalent SEMA control composition that was tested in that study. However, that brain biodistribution study employed a more sensitive fluorescently tagged SEMA detection bioassay methodology that was not a practical option for the present Study.
Investigatory animal work, such as this Study, is designed to assist the Company in its pursuit of furthering performance enhancements of existing and future potential DHT compositions. Lexaria is very pleased to have apparently made new discoveries, in particular in the area of relative brain absorption with DHT-CBD, and will be considering how to potentially leverage our new learnings and IP; as well as investigate the potential of utilization of those formulation enhancements to other drug categories. Of note, all four instances of discovering DHT ALT compositions that exhibited non-inferiority statistically speaking to the respective REF compositions were important advancements for the Company giving it optionality relative to certain IP strategies it is pursuing to facilitate its commercialization objectives.