DURECT Corporation to Host KOL Event on Alcohol-Associated Hepatitis

CUPERTINO, Calif., April 27, 2023 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced it will host a Key Opinion Leader ("KOL") event on Alcohol-Associated Hepatitis on May 16th in New York City. Topics of discussion will include the etiology and prevalence of alcohol-associated hepatitis (AH), current treatment insufficiencies and unmet need for patients with AH, biology of larsucosterol, trial design and status update for the Phase 2b AHFIRM trial in AH, and a company update on regulatory and commercial efforts ongoing for larsucosterol in AH. In addition to company management, two KOLs will provide their expert opinions on alcoholic liver disease and larsucosterol:

• Dr. Brett Fortune, Medical Director, Liver Transplant Program, and Associate Professor of Medicine at Montefiore Einstein.
• Dr. Paul Gaglio, Professor of Medicine (in Surgery) and director of Hepatology Outreach at NY-Presbyterian Hospital, Columbia University Irving Medical Center.

DURECT's KOL Event will also be broadcast online and can be accessed via the following:

Tuesday, May 16 @ 12:00pm Eastern Time / 9:00am Pacific Time

Webcast:                 https://www.webcaster4.com/Webcast/Page/359/48320

The webcast links will also be available by accessing DURECT's homepage at www.durect.com and clicking on "Events" under the "Investors" section. A replay will be available following the conclusion of the event.

About Larsucosterol (DUR-928)

Larsucosterol is an endogenous sulfated oxysterol and an epigenetic regulator. Epigenetic regulators are compounds that regulate patterns of gene expression without modifying the DNA sequence. DNA hypermethylation, an example of epigenetic dysregulation, results in transcriptomic reprogramming and cellular dysfunction, and has been found to be associated with many acute (e.g., AH) or chronic diseases (e.g., NASH). As an inhibitor of DNA methyltransferases (DNMT1, DNMT3a and 3b), larsucosterol inhibits DNA methylation, which subsequently regulates expression of genes that are involved in cell signaling pathways associated with stress responses, cell death and survival, and lipid biosynthesis. This may ultimately lead to improved cell survival, reduced inflammation, and decreased lipotoxicity. As an epigenetic regulator, the proposed mechanism of action provides further scientific rationale for developing larsucosterol for the treatment of acute organ injury and certain chronic diseases.

About DURECT Corporation

DURECT is a biopharmaceutical company committed to transforming the treatment of acute organ injury and chronic liver diseases by advancing novel and potentially lifesaving therapies based on its endogenous epigenetic regulator program. Larsucosterol (also known as DUR-928), DURECT's lead drug candidate, binds to and inhibits the activity of DNA methyltransferases (DNMTs), DNA-modifying enzymes that are elevated and associated with the hypermethylation found in patients with severe alcohol-associated hepatitis (SAH). Larsucosterol is in clinical development for the potential treatment of SAH, for which FDA has granted a Fast Track Designation. Non-alcoholic steatohepatitis (NASH) 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 has been exclusively licensed to Innocoll Pharmaceuticals for commercialization in the United States. For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.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 use of larsucosterol for the treatment of AH, the commercialization of POSIMIR by Innocoll, and the potential to develop larsucosterol for AH, NASH or 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 risks that the AHFIRM trial takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that ongoing and future clinical trials of larsucosterol do not confirm the results from 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 it for the treatment of AH even if the results of the AHFIRM trial are successful, 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 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, 2022 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 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 (DUR-928) 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