- Lexaria’s IND application builds on five previous human clinical studies showing zero serious adverse effects and evidencing a reduction in resting blood pressure in test subjects
- DehydraTECH(TM)-CBD has the potential to have pronounced clinical benefits relative to the available anti-hypertensive therapeutics on the market today
- Work mostly under Lexaria’s control was completed earlier this year, including the batch manufacturing of DehydraTECH-CBD and placebo materials necessary for the IND application
- Lexaria is waiting to submit until the necessary documentation outside of their control is ready for the IND application
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, remains on track for its upcoming Investigational New Drug (“IND”) submission. The application is for the company’s planned US Phase 1b Hypertension Clinical Trial HYPER-H23-1, entitled “A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension,” looks to evaluate the safety and tolerability of Lexaria’s patented DehydraTECH(TM)-processed CBD in hypertensive patients.
Lexaria’s IND submission builds on five previous human clinical studies conducted from 2018 to 2022 and is integral to the successful filing and review of the submission. These studies were carried out in an aggregate total of 134 healthy and hypertensive persons and evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens. The studies also showed zero serious adverse effects, evidencing Lexaria’s DehydraTECH-CBD’s potential to have pronounced clinical benefits relative to available anti-hypertensive therapeutics.
“That we were able to lower blood pressure in our patient population over multiple weeks using DehydraTECH-CBD is an exceptional discovery, given that previous studies by others using other oral CBD formulations have failed to evidence this sustained benefit,” said Chris Bunka, CEO of Lexaria (https://cnw.fm/rG6OB).
Work mostly under Lexaria’s control was completed earlier this year, including the batch manufacturing of DehydraTECH-CBD and placebo materials necessary for the IND application. However, work outside the company’s control remains delayed, including the provision of required documentation by a materials supplier and stability testing of the material. Despite this delay, Lexaria is still progressing toward its application submission.
The company is only aware of a handful of other published research investigating whether a decrease in resting blood pressure is possible following multiple weeks of oral CBD use. Lexaria notes that none of this published research has succeeded in achieving this goal. The outcomes of the company’s previous research prove DehydraTECH-CBD’s superior power to reduce blood pressure over oral CBD formulations.
Lexaria’s DehydraTECH technology is designed for formulating and delivering lipophilic drugs and active pharmaceutical ingredients (“APIs”). DehydraTECH increases their effectiveness and improves the way these APIs enter the bloodstream. The major benefits of a DehydraTECH-enabled drug or consumer product include:
- Faster delivery time – with the effects of the product felt in minutes
- Increased bioavailability – the technology is more effective at delivering a drug or product directly to the bloodstream
- Increased brain absorption – animal testing has suggested significant improvement in the quantity of the drug delivered across the blood-brain barrier
- Improved potency – more of the ingested product is made available to the body, with lower dosages necessary for the desired result
- Reduced administration costs – lower dosages mean less overall drug costs
- Masking unwanted tastes – the technology eliminates or reduces the need for sweeteners
DehydraTECH is suitable for use with various product formats, including pharmaceuticals, nutraceuticals, consumer packaged goods, topicals and over-the-counter capsules, pills, tablets, and oral suspensions. The company’s technology is best considered an additional layer that can improve the effectiveness of existing drug offerings or planned new offerings. Lexaria’s DehydraTECH is covered by over 30 granted patents and has many more pending worldwide.
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://cnw.fm/LEXX
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