News | September 8, 2021

Lexaria Begins Investigational New Drug (IND) Enabling Program For DehydraTECH-CBD For Hypertension

Positive results using DehydraTECH-CBD support progressing to FDA IND application

Lexaria Bioscience Corp. (the "Company" or "Lexaria"), a global innovator in drug delivery platforms today announced it is formally beginning the process towards an Investigational New Drug ("IND") application filing with the Food and Drug Administration ("FDA") with its DehydraTECH-processed cannabidiol ("DehydraTECH-CBD") as a prospective registered pharmaceutical treatment for hypertension.

Lexaria has retained the services of an expert regulatory affairs and quality assurance consultancy group that will help prepare Lexaria for a pre-IND meeting with the FDA, as well as with designing the necessary non-clinical, clinical and related product development IND-enabling work to be completed in advance of the IND filing.

Lexaria's new IND enabling program is made possible through successfully completed studies that have provided support for more ambitious commercial goals. Recently achieved successful results from two 2021 human clinical pharmacodynamic hypertension studies and a 2018 human clinical pharmacokinetic ("PK") study, along with a number of successful animal studies demonstrating PK performance and molecular characterization work completed through Canada's National Research Council, have together established a strong body of evidence for Lexaria's DehydraTECH-CBD. These studies have shown that DehydraTECH-CBD demonstrates superior bioabsorption upon oral administration and is effective at reducing blood pressure with no significant unwanted side effects.

Provided that ongoing and upcoming studies continue to deliver favorable results, and that IND and other approvals from regulators are obtained, Lexaria intends to progress to a New Drug Application ("NDA") at the appropriate time, possibly via the abbreviated 505(b)(2) pathway.

The IND application process is also expected to utilize data from the Company's third and fourth 2021 human clinical hypertension studies, whereby Lexaria hopes that these studies will contribute further valuable data to its growing information package.

Lexaria will provide details on the timing and specifics of its planned pre-IND meeting and of the non-clinical, clinical and related product development IND-enabling work program elements to be completed in advance of and to culminate in IND filing as these details become available.

In addition, Lexaria is evaluating whether additional therapeutic indications for DehydraTECH-CBD might be pursued with the FDA in due course.

About DehydraTECH-CBD
DehydraTECH-CBD is a unique CBD formulation Lexaria has developed and is optimizing based on its patented and proprietary DehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules including CBD into brain tissue, which Lexaria believes to be of particular importance for the effectiveness of its DehydraTECH-CBD specifically against hypertension because of the significant influence of central mediation upon blood pressure.

CBD in the Regulatory Environment.
CBD under the brand name Epidiolex was approved by the FDA in June 2018 for treating certain types of pediatric seizure disorders. Recommended dosing of Epidiolex CBD is 2.5 mg per kilogram of bodyweight to begin treatment, taken twice per day, increasing to 5.0 mg per kilogram of bodyweight, taken twice per day. An average 9 year-old child weighs about 28 kg, so the FDA recommended dose of Epidiolex would initially be 140 mg, increasing to 280 mg daily for long term use. The average adult man in the US weighs 199.6 lbs (90.7kg), so if he was using CBD at that same rate, he would require 900 mg per day for a sustainable dose. The maximum FDA-approved dose of Epidiolex is 10.0 mg per kilogram of bodyweight, taken twice daily.

Hypertension Markets
The hypertension market is valued at $28B per year and is expected to continue growing as one of the world's top health problems. Geographically, some of the highest rates of growth are expected in more recently industrialized nations such as China and India. Over 1.1 billion people worldwide suffer from hypertension.

Fewer than 1 person in 4 with hypertension have successfully controlled their blood pressure through medications, meaning the potential market for hypertension drugs is much larger than $28B per year if an affordable drug was available with few or no side effects. Lexaria believes that its DehydraTECH-CBD may introduce a more tolerable anti-hypertensive treatment option that may be used alone or in combination with other medications, to reduce BP with fewer discouraging and unwanted side effects. Lexaria would seek to satisfy this currently unmet demand and in doing so could expand the overall hypertension market.

"Among persons 50 years of age or older, isolated systolic hypertension is the most common form of hypertension, and systolic blood pressure becomes more important than diastolic blood pressure as an independent risk predictor for coronary events, stroke, heart failure, and end-stage renal disease (ESRD). The Global Burden of Disease Study identified elevated blood pressure as the leading risk factor, among 67 studied, for death and disability-adjusted life-years lost during 2010."

Drugs focused on blood pressure and related conditions are some of the highest selling drugs in the world. Lipitor, used to treat high cholesterol and reduce the risk of heart disease, has generated $94.7B in revenue from 1992 until 2017. Plavix, used to prevent heart attack and stroke, has sold $46.5B from 1992 until 2017. There are several hypertension drugs that each generate $1B per year or more in revenue.

Source: Lexaria Bioscience Corp.