- Lexaria is a biotechnology company pursuing the enhancement of the bioavailability of a diverse and broad range of active pharmaceutical ingredients (“APIs”)
- The company has developed the patented DehydraTECH(TM) drug delivery technology, which has been shown to deliver more API at a faster rate than controls
- Lexaria’s DehydraTECH pipeline includes DehydraTECH-CBD for the treatment of hypertension
- Through pre-clinical studies, DehydraTECH-CBD has been shown to decrease systolic blood pressure among hypertensive volunteers
- The company intends to file an Investigational New Drug (“IND”) application and has already received confirmation that the FDA agrees with its proposed abbreviated pathway under section 501(b)(2)
Oral delivery remains the preferred route of administering drugs among cooperating and conscious patients. But some drugs do not have the desired physicochemical and pharmacokinetic characteristics that favor oral administration, an issue that is linked to poor bioavailability. This has often led to the use of other routes or prompted the administration of higher doses, with the latter causing toxicity concerns and risks tied to erratic and unpredictable responses. These challenges, coupled with the fact that more than 90% of therapeutic compounds are known to possess oral bioavailability limitations, have necessitated research that explores ways to enhance oral drug bioavailability (https://ibn.fm/xQ0vX).
The research has been spearheaded by scholars and scientists as well as companies such as Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms. A biotechnology company focusing its attention and resources on pursuing the enhancement of the bioavailability of a diverse and broad range of active pharmaceutical ingredients (“APIs”), Lexaria developed the patented DehydraTECH(TM) drug delivery technology.
Designed to be incorporated into the formulation and manufacturing process of existing or new topical and ingestible products, the technology works with existing physiological systems to facilitate enhanced and more rapid absorption of drugs into the bloodstream and cells. In fact, the company has evidenced, through in vivo, in vitro and pre-clinical testing, that DehydraTECH delivers more API at a faster rate than controls, enabling more effective drug absorption. The testing has so far involved APIs such as cannabidiol (“CBD”), PDE5 inhibitors, antiviral drugs, and nicotine, each at different stages of product development.
This DehydraTECH pipeline, Lexaria says, is addressing severe unmet patient needs. Its DehydraTECH-CBD compound, for example, specifically targets the hypertension space; in the U.S., about 47% of adults, or 116 million people, have hypertension, with only about 24% having the condition under control (https://ibn.fm/ZEKeM), while globally, hypertension affects more than 1 billion people, or about 30% of the adult population (https://ibn.fm/sdKDi).
A person is considered hypertensive if and when their systolic blood pressure (when the heart is beating) exceeds 130 mmHg or their diastolic blood pressure (when the heart is at rest) is greater than 80 mmHg or if they are on hypertension medication. This heightened pressure has several consequences, including the fact that it makes arteries less elastic, effectively damaging them. This damage, in turn, decreases the blood flow and oxygen to the heart, leading to heart disease. The decreased blood flow also increases the risk of stroke.
In extreme cases, hypertension causes death. In 2020, over 670,000 people died from hypertension in the United States, according to the Centers for Disease Control (“CDC”). Globally, the World Health Organization (“WHO”) reports, 7.5 million people die from high blood pressure annually (https://ibn.fm/HCtyI). Unfortunately, some of these deaths occur among patients who may not have noticed any symptoms, leading to the recognition of hypertension as a “silent killer.” The good news? There are several approved blood pressure medications, with scores still under development or evaluation, including Lexaria’s DehydraTECH-CBD.
In its human pre-clinical studies, Lexaria has shown that DehydraTECH delivers 317% more CBD to the bloodstream. Its HYPER-H21-1 study demonstrated that DehydraTECH-CBD results in a rapid and sustained drop in blood pressure, particularly systolic pressure and especially in stage 2 hypertensive volunteers (those whose systolic pressure exceeds 140 mmHg). In addition, the company separately showed, through its HYPER-H21-2 study, that its drug candidate results in a 23% average reduction in overnight blood pressure and reduces arterial stiffness, while its HYPER-H21-3 study demonstrated attenuated pulmonary artery systolic pressure by -5 mmHg (https://ibn.fm/hCT43).
Motivated by the positive results, Lexaria is marching toward filing an Investigational New Drug (“IND”) application, having already received confirmation from the U.S. Food and Drug Administration (“FDA”) that the agency had agreed with the company’s proposal to pursue the 505(b)(2) new drug application (“NDA”) abbreviated regulatory pathway (https://ibn.fm/NQaBK).
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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