Lexaria Bioscience provides update on DEM-A22-1, EPIL-A21-1 programs

As announced on November 10, 2022, study DEM-A22-1 was undertaken in thirty-two Long Evans rats using the established novel object recognition test, which is used to assess memory in rodents, in order to investigate whether DehydraTECH-CBD enables any pro-cognitive performance enhancements in this model, potentially of use in dementia treatment. The findings from this study were generally unremarkable and several unexpected study complications may have muted efficacy distinction ability. Most notably, the aged rats where cognitive impairment was expected to be most obvious did not, in fact, adequately exhibit this impaired tendency, making “improvements” difficult to measure. Also, animals in the high dose DehydraTECH-CBD cohort exhibited reduced locomotor activity, which may have indicated that treatment at this level produced sedative activity, also masking any prospective cognitive improvement. Together, these inconclusive results may point to required study design improvements necessary for a more concrete set of results. While this research did not produce any notable outcomes, Lexaria now recognizes that previous research by other investigators using CBD in this animal model has required dosing over a much longer duration, than Lexaria has thus far evaluated-. Lexaria will consider this if further testing is considered in future, potentially also including DehydraTECH-processed nicotine, as previously announced, as another agent known to enhance cognitive performance when effectively delivered. Epilepsy: EPIL-A21-1: As announced on November 29, 2022, Lexaria successfully completed two parts of its EPIL-A21-1 study program designed to evaluate the effectiveness of its DehydraTECH-CBD compared to one of the world’s leading anti-seizure medications, Epidiolex, in reducing seizure activity using an established, vehicle-controlled, acute animal seizure model induced by electrical stimulation. The findings from this work appear to demonstrate that DehydraTECH-CBD had effectiveness at lower doses and with greater rapidity than Epidiolex. Since that time, Lexaria has also completed a final MES study under its EPIL-A21-1 program designed to establish an ED50 (i.e., the dose required to achieve seizure inhibition in 50% of the animals tested) for DehydraTECH-CBD in this animal model, where ED50 determination is a common performance metric in preclinical animal studies for developmental therapeutics. This ED50 study was designed with an objective to hopefully corroborate Lexaria’s prior MES experimental findings. Lexaria is pleased to confirm that the outcome demonstrated that DehydraTECH-CBD was most effective at a dose of 75 mg/Kg, also as previously reported from the initial round of work in this animal model which compared favourably to Epidiolex that generally required a higher dose of 100 mg/Kg to achieve comparable findings.