DURECT Corporation to Present Data on Larsucosterol at The Liver Meeting 2024

Rhea-AI Summary

DURECT (Nasdaq: DRRX) will present data on larsucosterol at The Liver Meeting 2024, organized by the American Association for the Study of Liver Diseases (AASLD), from November 15-19 in San Diego. The presentations will showcase additional data from DURECT's completed Phase 2b trial evaluating larsucosterol for the treatment of alcohol-associated hepatitis (AH).

The presentations include:

• An oral presentation on the effects of timely treatment on outcomes of larsucosterol for severe AH
• A poster on the ethical dilemmas of liver transplantation as an endpoint in AH trials
• A poster on drinking behavior in the AHFIRM trial as measured by Phosphatidyl Ethanol

These presentations will provide further support for the design of DURECT's upcoming Phase 3 trial of larsucosterol in AH, emphasizing the importance of timely treatment in clinical outcomes.

CUPERTINO, Calif., Oct. 17, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX), a late-stage biopharmaceutical company pioneering the development of epigenetic therapies to transform the treatment of serious and life-threatening conditions such as acute organ injury, today announce that it will deliver an oral and two poster presentations at The Liver Meeting 2024, organized by the American Association for the Study of Liver Diseases (AASLD), to be held November 15-19, 2024 in San Diego, California.

The presentations will showcase additional data from DURECT's completed Phase 2b trial evaluating its lead asset, larsucosterol, for the treatment of alcohol-associated hepatitis (AH). The data further support the design of the Company's upcoming Phase 3 trial of larsucosterol in AH, including the importance of timely treatment in clinical outcomes.

Presentation details are as follow:

Oral Presentation:
Title: Effects of Timely Treatment on Outcomes of Larsucosterol for Severe Alcohol-associated Hepatitis (AHFIRM Trial)
Presentation Number: 198
Session: Abstract Parallel Sessions - PBC, Alcohol-associated Hepatitis, Hepatitis B, Portal Hypertension, Costs of Care
Date and Time: November 18, 12:15 - 12:30 pm PT
Presenter: Lance Stein, Piedmont Healthcare, Atlanta, GA, USA

Poster Presentations:
Title: A Balancing Act: The Life-Saving Potential and Ethical Dilemmas of Liver Transplantation as an Endpoint in Alcohol Associated Hepatitis Trials
Presentation Number: 3040
Session: Abstract Poster - Alcohol-Associated Liver Diseases: Clinical and Experimental
Date and Time: November 17, 1:00 PM-2:00 PM (posters will be available from 8:00 AM - 5:00 PM PT)
Presenter: Aparna Goel, Stanford University Medical Center, Stanford, CA, U.S.

Title: Drinking Behavior in the AHFIRM trial as measured by Phosphatidyl Ethanol
Presentation Number: 3140
Session: Abstract Poster - Alcohol-Associated Liver Diseases: Clinical and Experimental
Date and Time: November 17, 1:00 PM-2:00 PM (posters will be available from 8:00 AM - 5:00 PM PT)
Presenter: Steven Flamm, Rush University, Chicago, IL, U.S.

About DURECT Corporation
DURECT is a late-stage biopharmaceutical company pioneering the development of epigenetic therapies that target dysregulated DNA methylation to transform the treatment of serious and life-threatening conditions, including acute organ injury. Larsucosterol, DURECT's lead drug candidate, binds to and inhibits the activity of DNA methyltransferases, epigenetic enzymes that are elevated and associated with hypermethylation found in AH patients. Larsucosterol is in clinical development for the potential treatment of AH, for which the FDA has granted a Fast Track and a Breakthrough Therapy designation; MASH is also being explored. In addition, POSIMIR^® (bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER^® platform technology, is FDA-approved and is exclusively licensed to Innocoll Pharmaceuticals for sale and distribution in the United States. For more information about DURECT, please visit www.durect.com and follow us on X (formerly Twitter) at https://x.com/DURECTCorp.

DURECT Forward-Looking Statements
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: the potential benefits of Breakthrough Therapy designation, and the potential uses and benefits of laruscosterol in patients with AH and potentially other indications. Actual results may differ materially from those contained in the forward-looking statements contained in this press release, and reported results should not be considered as an indication of future performance. The potential risks and uncertainties that could cause actual results to differ from those projected include, among other things, the risk that future clinical trials of larsucosterol are delayed or do not confirm the results from subset analyses of the AHFIRM trial, including geographic or other segmentation, or of earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of larsucosterol in a statistically significant manner; the risk that the FDA or other government agencies may require additional clinical trials for larsucosterol before approving larsucosterol for the treatment of AH, the risk that Breakthrough Therapy designation does not expedite the process for FDA approval and that larsucosterol may never be approved; risks that Innocoll may not commercialize POSIMIR successfully; and risks related to the sufficiency of our cash resources, our anticipated capital requirements, our need or desire for additional financing, our ability to continue to meet the minimum bid price for continued listing on Nasdaq, our ability to obtain capital to fund our operations and expenses, and our ability to continue to operate as a going concern. Further information regarding these and other risks is included in DURECT's most recent Securities and Exchange Commission (SEC) filings, including its annual report on Form 10-K for the year ended December 31, 2023 and quarterly report on Form 10-Q for the quarter ended June 30, 2024, under the heading "Risk Factors."  These reports are available on our website www.durect.com under the "Investors" tab and on the SEC's website at www.sec.gov. All information provided in this press release and in the attachments is based on information available to DURECT as of the date hereof, and DURECT assumes no obligation to update this information as a result of future events or developments, except as required by law.

NOTE: POSIMIR^® is a trademark of Innocoll Pharmaceuticals, Ltd. in the U.S. and a trademark of DURECT Corporation outside of the U.S. SABER^® is a trademark of DURECT Corporation. Other referenced trademarks belong to their respective owners. Larsucosterol is an investigational drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication.

 

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SOURCE DURECT Corporation

FAQ

What data will DURECT present at The Liver Meeting 2024?

DURECT will present additional data from their completed Phase 2b trial evaluating larsucosterol for the treatment of alcohol-associated hepatitis (AH) at The Liver Meeting 2024.

When and where will The Liver Meeting 2024 take place?

The Liver Meeting 2024, organized by the American Association for the Study of Liver Diseases (AASLD), will be held from November 15-19, 2024 in San Diego, California.

What is the focus of DURECT's oral presentation at The Liver Meeting 2024?

DURECT's oral presentation will focus on the effects of timely treatment on outcomes of larsucosterol for severe alcohol-associated hepatitis, based on the AHFIRM trial.

What topics will DURECT's poster presentations cover at The Liver Meeting 2024?

DURECT's poster presentations will cover the ethical dilemmas of liver transplantation as an endpoint in alcohol-associated hepatitis trials and drinking behavior in the AHFIRM trial as measured by Phosphatidyl Ethanol.

How will the presented data support DURECT's future plans for larsucosterol?

The presented data will further support the design of DURECT's upcoming Phase 3 trial of larsucosterol in alcohol-associated hepatitis, emphasizing the importance of timely treatment in clinical outcomes.