cannabidiol (DehydraTECH-CBD) / Lexaria Biosci - LARVOL DELTA

Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants (clinicaltrials.gov) - P1 | N=148 | Active, not recruiting | Sponsor: Lexaria Bioscience Corp. | Recruiting ➔ Active, not recruiting | N=80 ➔ 148

Enrollment change • Enrollment closed • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Lexaria's Phase 1b GLP-1 Study Achieves Important "Last Patient Last Visit" Milestone (ACCESS Newswire) - "'Study work continues with full sample and data analyses currently underway in order to reach our late 2025 final reporting objective.'"

Enrollment closed • P1 data • Obesity • Type 2 Diabetes Mellitus

Lexaria Provides Update on Material Transfer Agreement with Pharmaceutical Company (ACCESSWIRE) - "Lexaria Bioscience Corp...provides this update on corporate developments...Lexaria today announces that the initial pre-clinical studies covered by the MTA, which examined pharmacokinetics in animals, have been performed. Results of that work will not be made public. In addition, Lexaria reports being informed by PharmaCO that they wish to review the pending safety (adverse events) and efficacy data from Lexaria’s ongoing independent human study GLP-1-H24-4 currently underway in Australia. We expect that data to become available beginning in Q3, 2025....The parties have agreed to continue their relationship under the MTA and to keep the temporary exclusive license active and in force until such time as the data from the Australian study becomes available and final decisions have been made, at which time further information will be provided."

Commercial • P1 data • Obesity • Type 2 Diabetes Mellitus

Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants (clinicaltrials.gov) - P1 | N=80 | Recruiting | Sponsor: Lexaria Bioscience Corp. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Comparison of the Safety, Efficacy and Pharmacokinetics of DehydraTECH -CBD and DehydraTECH-GLP1 Agonists Alone or in Combination, in Overweight or Obese, Pre- and Type 2 Diabetic Participants (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Lexaria Bioscience Corp.

New P1 trial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Differences in Plasma Cannabidiol Concentrations in Women and Men: A Randomized, Placebo-Controlled, Crossover Study. (PubMed, Int J Mol Sci) - "Here, we report a triple-blind (participant, investigator, and outcome assessor) placebo-controlled crossover study in which 62 hypertensive volunteers were randomly assigned to receive the recently developed DehydraTECH2.0 CBD formulation or a placebo...Significantly higher plasma CBD concentrations occurred in females compared to males, which was potentially related to greater adipose tissue. More research is needed to optimize CBD doses to consider the differential therapeutic benefits in men and women."

Journal

Trial of a Novel Oral Cannabinoid Formulation in Patients with Hypertension: A Double-Blind, Placebo-Controlled Pharmacogenetic Study. (PubMed, Pharmaceuticals (Basel)) - "Both CYP2C19*2 (p = 0.037) and CYP2C19*17 (p = 0.022) were negatively associated with urinary CBD levels (beta = -0.489 for CYP2C19*2 and beta = -0.494 for CYP2C19*17). Further research is required to establish the impact of CYP P450 enzymes and the identification of metabolizer phenotype for the optimization of CBD formulations."

Biomarker • Journal • Cardiovascular • Hypertension • CYP2C19 • CYP2C9

Lexaria's DehydraTECH-CBD Enhances Performance Compared to Epidiolex in Seizure Study Program (Yahoo Finance) - "Lexaria Bioscience Corp...announces that its patented DehydraTECH-CBD™ has demonstrated performance enhancements compared to one of the world’s leading anti-seizure medications, Epidiolex®....Lexaria is encouraged by these results from its first foray into the anti-seizure testing field. The results to-date demonstrate the performance of DehydraTECH-CBD to reduce or eliminate seizure activity in animals and to, in some cases, even surpass the performance of one of the world’s leading anti-seizure medications, Epidiolex."

Preclinical • CNS Disorders • Epilepsy

"$LEXX $LEXXW Lexaria’s DehydraTECH-CBD(TM) Enhances Performance Compared to Epidiolex(R) in Seizure Study Program https://t.co/dYF8JvNPq9" (@stock_titan)

CNS Disorders • Epilepsy

"$LEXX $LEXXW Lexaria Starts Study Evaluating the Effect of DehydraTECH-CBD on Diabetes https://t.co/wkM2bf8pLK" (@stock_titan)

Diabetes • Metabolic Disorders

Chronic Effects of Effective Oral Cannabidiol Delivery on 24-h Ambulatory Blood Pressure and Vascular Outcomes in Treated and Untreated Hypertension (HYPER-H21-4): Study Protocol for a Randomized, Placebo-Controlled, and Crossover Study. (PubMed, J Pers Med) - "The present single-center study is designed as a triple blind (Participant, Investigator, Outcomes Assessor), placebo-controlled, crossover pilot study in which 70 hypertensive volunteers (aged 40-70 years) will receive DehydraTECH2.0 CBD formulation and placebo in a crossover manner. We believe that comprehensive analyses that will be performed in the present trial will decipher whether CBD is in fact a safe and valuable supplement for patients with treated and untreated hypertension."

Journal • Cardiovascular • Hypertension • Immunology • Inflammation

"$LEXX Lexaria’s Licensee Premier Wellness Science Co., Ltd. Launches New Brand in Preparation to Deploy DehydraTECH CBD Products in Japan https://t.co/NdFlzYsPmS" (@otcdynamics)

Launch Japan

HYPER-H21-4: Oral Cannabidiol Effect on Blood Pressure in Hypertensive Patients (clinicaltrials.gov) - P1 | N=70 | Active, not recruiting | Sponsor: University of Split, School of Medicine

New P1 trial • Hypertension • CRP

Lexaria Bioscience Commences DehydraTECH-CBD Epilepsy Research Program (Benzinga) - "Lexaria Bioscience...announced that the first phase of its epilepsy research program EPIL-A21-1 is beginning this week. According to the update, the DehydraTECH(TM)-CBD test articles needed to commence dosing have already been manufactured and delivered to the third-party laboratory engaged to complete this research program. EPIL-A21-1 will assess the seizure inhibiting activity of DehydraTECH-CBD compared to the world’s only FDA-approved CBD-based seizure medication, Epidiolex(R). Lexaria hopes to demonstrate superior performance based on DehydraTECH’s known advanced drug delivery capabilities."

Preclinical • CNS Disorders • Epilepsy

"@DrOz Lexaria Bioscience Corp.’s (NASDAQ: LEXX) DehydraTECH(TM)-CBD Reduces Arterial Stiffness in Study HYPER-H21-2 Broadening Applications Beyond Hypertension - CBDWire https://t.co/qw6mNUT77p" (@DisruptiveTec11)

Hypertension

Lexaria Announces R&D Program to Compare First and Only FDA-Approved Prescription Cannabidiol (BioSpace) - "Lexaria Bioscience Corp...has commenced an important new study exploring whether DehydraTECHTM-CBD evidences superior ability to inhibit seizure activity compared to both generic cannabidiol ('CBD') and Epidiolex...Animal study EPIL-A21-1 has entered early-stage preparatory work and results are expected by Q3 2022."

Preclinical • CNS Disorders • Epilepsy