PCG Digital - Lexaria Bioscience (NASDAQ: LEXX) (NASDAQ: LEXXW) is targeting the $28 billion hypertension drug market with its innovative drug delivery platform. Its proprietary therapeutic, DehydraTECH-CBD, offers an alternative to traditional cannabidiol (CBD) dosing methods, enabling improved and more rapid absorption of drugs into the bloodstream and brain.

There is currently only one FDA approved CBD drug available on the market, used to treat pediatric epilepsy. Lexaria is positioned to potentially deliver the second-ever FDA approved CBD therapeutic, which has the potential to be life-changing for those living with hypertension.

Hypertension is a serious public health issue. Over 116 million Americans, and more than a billion adults worldwide, are living with high blood pressure, a major cause of premature death. However, as hypertension diagnosis numbers continue to climb, there has been a marked slowing of research and development for novel hypertension drugs.

Lexaria Bioscience

We spoke with Professor Philip Ainslie, PhD, Lead Investigator in Lexaria's human hypertension studies, to find out more about how Lexaria is working to develop a best-in-class delivery method for hypertension drugs.

Q: How does Lexaria's DehydraTECH drug delivery system work, and how does it improve the performance of existing therapeutics?

Our studies have demonstrated that DehydraTECH formulations begin to take effect in as little as 1.5 minutes after dosing, and that intestinal bioabsorption of bioactive compounds is increased by as much as 27x. The result is greater bioavailability of therapeutics at reduced doses.

CBD is a complex fat-soluble molecule and is known to have poor absorption characteristics. Typically only about 6% of what is orally ingested enters the bloodstream. Through our pre-clinical and human studies, we have shown that DehydraTECH technology enables absorption increases of between 100% and 500%.

Q: Why is Lexaria targeting hypertension?

It is estimated that just one in five people diagnosed with hypertension take medication with patients citing side effects of these medications as outweighing the benefits. Hypertension is the most common cardiovascular disease worldwide and is associated with severe long-term morbidity if left untreated. We believe there is significant unmet demand for more tolerable, cost-effective anti-hypertensive treatments.

Based on our extremely promising early results, Lexaria has an opportunity to develop a new treatment with few or no side effects - addressing the majority of patient concerns about taking hypertension medication. In future, DehydraTECH-CBD may be used alone or in conjunction with other hypertension medications to reduce blood pressure. Research to establish the safety and feasibility of this is currently underway as discussed next.

Q: Can you describe your most recent study?

A: Our most recently completed human hypertension study in 2022 built on the significant reductions in blood pressure demonstrated in our 2021 studies, which showed that DehydraTECH-CBD enabled a rapid and sustained drop in blood pressure in hypertensive volunteers. The improvements in blood pressure results were particularly remarkable given the fact that many existing drugs used to treat hypertension require several weeks of treatment and/or combination dosing before they produce comparable reductions in blood pressure.

Our recent study, HYPER-H21-4, allowed us to gather critical data monitoring safety and efficacy of DehydraTECH-CBD over an extended period of time and will enable us to evaluate the potential for longer term health benefits. The study was a multi-week randomized, double blinded, placebo-controlled, cross-over study evaluating 64 patients with hypertension. Maximum CBD dose levels were significantly lower than maximum dose levels practiced for other regulator-approved pharmaceutical CBD applications, which we believe may be beneficial in avoiding unwanted side effects such as elevated liver enzymes.

In our upcoming clinical trials, we will be looking to demonstrate a noteworthy safety and tolerability profile relative to conventional anti-hypertensive medications, while avoiding serious adverse events at clinically efficacious doses.

Q: Lexaria is on track to file its full IND application by the end of 2022, or early in 2023. Can you tell us more about the FDA's initial feedback?

We were delighted to receive positive feedback from the FDA, supporting our proposal to pursue a 505(b)(2) New Drug Application (NDA). This type of NDA typically enables a faster route to commercial approval than the traditional pathway, which is excellent news for Lexaria and its investors. The FDA confirmed that additional non-clinical studies would not be required prior to initiation of Lexaria's IND program, given the compelling CBD safety and tolerability data we have already presented.

Following receipt of this positive feedback, Lexaria immediately commenced IND-enabling work and we are on track to file a full IND application by the end of 2022 or early 2023, six to nine months sooner than if the FDA had required modifications in our current IND-enabling work plan.

Q: Why has it been important to establish safety in your CBD studies?

A: CBD is usually well-tolerated, but in the high therapeutic doses required for conditions such as epilepsy or hypertension, it has the potential to cause liver toxicity. In the case of Epidiolex - the only FDA approved CBD therapeutic - the maximum approved dose is 10mg per kilogram of body weight, taken twice daily. Due to its ability to increase a compound's bioavailability, DehydraTECH-CBD has the potential to be prescribed to patients at reduced doses. This is particularly important in the case of therapeutics such as colchicine, an antiviral agent where the distinction between toxic and non-toxic doses is marginal. There could be significant benefits in allowing its dosing to be reduced while maintaining therapeutic delivery levels and we have already been investigating a range of doses lower than those already approved by FDA for Epidiolex, for example.

Q: Lexaria is pursuing commercialization of DehydraTECH-CBD for hypertension. What are the next steps on the path to regulatory approval?

Filing our IND application is the next major regulatory step we are working towards, and we expect to submit this by the end of the year, or early next year. Our proposed Phase 1b clinical trial will involve dosing approximately 100 hypertension patients with DehydraTECH-CBD to evaluate the safety and efficacy of the treatment on office and 24-hr ambulatory blood pressure. We expect to begin this US-based clinical study as soon as practically possible following IND approval.

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