- Lexaria’s HYPER-H21-4 human clinical study was a success, producing favorable results in treating hypertension when comparing the company’s patented DehydraTECH(TM) CBD with a placebo
- According to a Zacks SCR report, the findings support their $15 share valuation of the company
- Zacks expects Lexaria to penetrate global markets for hypertension, nicotine delivery and antiviral products
- The hypertension drug market is expected to grow to over $34 billion through 2030, with North America anticipated to hold 35% of the market share
According to the World Health Organization (“WHO”), approximately 1.13 billion people worldwide suffer from hypertension (high blood pressure), with only one in five being treated or under control. The hypertension drug market size in 2021 was valued at $25,394 million and is expected to grow at a CAGR of 3.4% through 2030, resulting in an estimated value of $34,072 million. The North American market is expected to lead with more than 35% of the world market share (https://ibn.fm/QQ33h).
Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, recently released impressive results from its fourth and most comprehensive hypertension study, HYPER-H21-4. The study, structured as a randomized, double-blind, placebo-controlled cross-over study, dosed 66 male and female volunteers between the ages of 40-70 with stage 1 or 2 hypertension, comparing the company’s patented DehydraTECH(TM) cannabidiol (“CBD”) against a placebo. The study showed patients receiving placebo doses trended toward increases in blood pressure (“BP”) during the period of the study compared to baseline, while the average BP measured by each of mean arterial BP, systolic BP and diastolic BP significantly decreased from baseline when dosed with DehydraTECH-CBD; and those decreases were maintained during the full 5 weeks of dosing – with no serious adverse events or hepatic changes occurring (https://ibn.fm/38KF3).
Lexaria’s DehydraTECH technology is designed specifically for formulating and delivering lipophilic (fat-soluble) drugs and active ingredients, increasing effectiveness and improving the way that active pharmaceutical ingredients (“APIs”) enter the bloodstream. In 2021, animal studies demonstrated that DehydraTECH elevated drug quantities across the blood-brain barrier by as much as 1,700%, which initiated further investigations and opened the possibilities for improved drug delivery.
The benefits of using Lexaria’s patented technology include the following:
- Improves the speed of onset, with effects felt in minutes
- Increases bioavailability by more effectively delivering the drug into the bloodstream
- Increases brain absorption, with testing suggesting up to 10x improvement
- Reduces drug administration costs with a higher ratio of drug delivery
Lexaria announced the enrollment for HYPER-H21-4 in an April 19 press release, and dosing began ahead of schedule, with completion on July 27, with no serious adverse events reported as a result of the dosing. The maximum dose levels in the study were roughly 5 mg/kg/day, which is significantly lower than maximum dose levels practiced for other regulator-approved pharmaceutical CBD applications., The company will use data from the study to support its Investigational New Drug (“IND”) application with the FDA.
According to a Zacks Small-Cap Research (“Zacks SCR”) report, the company’s next steps for the hypertension program will be to submit and receive clearance for an IND application, and the application and IND clearance will support the start of the Phase Ib study slated for 2023 (https://ibn.fm/L7LRB). Longer term goals for the program are to find a partner who will advance the work to a registrational study and send it to the FDA for approval. While this is several years away, the data that has been released so far is supportive of further development.
Zacks SCR forecasts penetration by Lexaria into global markets for hypertension, nicotine delivery, and antiviral product categories. The Zacks SCR valuation of $15 per share assumes a 2024 regulatory approval and commercialization of DehydraTECH CBD in the United States and developed markets – a valuation maintained throughout the report.
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://ibn.fm/LEXX
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