Lexaria's Hormone Study Shows Significant Enhancement in Oral Estradiol Delivery

900% and 2,000% improvements in peak bloodstream delivery using DehydraTECH

KELOWNA, BC / ACCESSWIRE / May 18, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that its animal study HOR-A22-1 has successfully completed, showing significant enhancement in the oral delivery of the estrogen hormone estradiol, an important component of therapeutic products in the women's health sector.

The DehydraTECH-estradiol formulation achieved an average peak concentration in the bloodstream (or "Cmax") of 5.65ng/mL that was roughly nine times (900%) higher than that achieved with the control formulation at only 0.63 ng/mL. As well, because estradiol is known to be quickly converted into the metabolite estrone by cells in the uterus, mammary glands and liver, estrone levels were also quantified in the study. This revealed that levels of the estrone metabolite were also significantly higher comparing an average Cmax of 6.49 ng/mL with the DehydraTECH formulation to only 0.302 ng/mL achieved with the control, representing greater than a twenty-fold (2,000%) improvement in delivery.

Foto: Accesswire

Average Estradiol and Estrone Cmax in Blood Plasma Following DehydraTECH-Estradiol and Control Administration

Also, the total estradiol and estrone recovery in the blood plasma over time or the Area Under the Curve ("AUC") was dramatically higher at 3.9 hr·ng/mL for estradiol and 32.6hr·ng/mL for the estrone with the DehydraTECH composition versus being non-detectable below the lower limit of quantitation of the assay (i.e., 0.25 ng/mL) with the control in both instances. This means that the AUC findings were at least fifteen times (1,500%) greater than the control for estradiol and over one hundred and twenty-five times (12,500%) greater for estrone.

Oral estradiol therapy is commonly used by women in birth control products, as well as to help reduce the symptoms of menopause and protect bone health. The hormone replacement market is estimated at $46.5 billion in 2027.

Oral estradiol formulations are known to have very low bioavailability, generally in the 5% range, necessitating relatively high dosages to achieve the desired beneficial effects. This, in turn, can lead to unwanted side effects ranging from gastrointestinal complications such as nausea, vomiting, diarrhea, stomach cramps and bloating, to other issues such as headache, dizziness, rash and more. Lexaria's DehydraTECH processing may offer a new approach to formulating estradiol and potentially other human hormone therapies for enhanced oral delivery toward improved safety and efficacy if pursued and proven ultimately clinically in humans.