Sign In  |  Register  |  About Menlo Park  |  Contact Us

Menlo Park, CA
September 01, 2020 1:28pm
7-Day Forecast | Traffic
  • Search Hotels in Menlo Park

  • CHECK-IN:
  • CHECK-OUT:
  • ROOMS:

InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Announces Submission of IND for Planned Phase 1b Hypertension Trial

Lexaria Bioscience (NASDAQ: LEXX, LEXXW), a global innovator in drug-delivery platforms, has submitted its much-anticipated Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”). The application covers HYPER-H23-1, the company’s upcoming planned U.S. phase 1b hypertension clinical trial of DehydraTECH-CBD. According to the announcement, the company had a successful pre-IND meeting with FDA officials. Following the guidance provided in that meeting regarding the development and filing of the IND, the company submitted the application on Jan. 29, 2024. The company will now wait 30 calendar days before initiating any clinical trials, in compliance with FDA guidelines. During that 30-day period, the FDA may review the IND for safety concerns. The primary focus of the trial will be to evaluate safety and tolerability in hypertensive patients with secondary goals including to study the efficacy of reducing blood pressure together with detailed pharmacokinetic testing. “Lexaria looks forward to commencing clinical trial HYPER-H23-1 as soon as possible following IND effectiveness, subject to certain conditions, including funding,” the company stated in the press release. “The IND review process when successfully concluded will be an important milestone achievement for Lexaria demonstrating that its DehydraTECH technology has met high-level formal regulatory scrutiny towards prospective future pharmaceutical commercial registration.”

To view the full press release, visit https://ibn.fm/zbCfg

About Lexaria Bioscience Corp.

Lexaria Bioscience’s patented drug-delivery formulation and processing platform technology, DehydraTECH(TM), improves the way active pharmaceutical ingredients (“APIs”) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bioabsorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed, in-house research laboratory and holds a robust intellectual property portfolio with 38 patents granted and many patents pending worldwide. For more information about the company, please visit 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

About InvestorWire

InvestorWire (“IW”) is a specialized communications platform with a focus on advanced wire-grade press release syndication for private and public companies and the investment community. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, IW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, IW brings its clients unparalleled recognition and brand awareness. IW is where breaking news, insightful content and actionable information converge.

For more information, please visit https://www.InvestorWire.com

Please see full terms of use and disclaimers on the InvestorWire website applicable to all content provided by IW, wherever published or re-published: https://www.InvestorWire.com/Disclaimer

InvestorWire
Los Angeles, CA
www.InvestorWire.com
310.299.1717 Office
Editor@InvestorWire.com

InvestorWire is powered by IBN

Data & News supplied by www.cloudquote.io
Stock quotes supplied by Barchart
Quotes delayed at least 20 minutes.
By accessing this page, you agree to the following
Privacy Policy and Terms and Conditions.
 
 
Copyright © 2010-2020 MenloPark.com & California Media Partners, LLC. All rights reserved.