Benzinga | Sep 8, 2021 07:19AM EDT

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

Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (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.