DURECT Corporation (Nasdaq: DRRX) today announced it dosed the first patient in the European Union as part of its AHFIRM randomized, double-blind, placebo-controlled, multi-center Phase 2b study to evaluate the safety and efficacy of larsucosterol in severe alcohol-associated hepatitis (AH) patients.
CUPERTINO, Calif., March 1, 2022 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced it dosed the first patient in the European Union as part of its AHFIRM randomized, double-blind, placebo-controlled, multi-center Phase 2b study to evaluate the safety and efficacy of larsucosterol in severe alcohol-associated hepatitis (AH) patients. “Dosing the first patient in Europe is an important milestone as we continue to make progress in the AHFIRM trial,” stated James E. Brown, D.V.M., President and CEO of DURECT. “AH is a life-threatening disease in many regions of the world and, accordingly, we now have clinical trial sites open across the U.S., Australia, U.K. and the E.U.” About the AHFIRM Trial About alcohol-associated hepatitis (AH) About DURECT Corporation DURECT Forward-Looking Statement. This press release contains forward-looking statements relating to, among other things, DURECT’s relationship with Innocoll, statements about the potential for larsucosterol (also known as DUR-928) to treat patients with AH, NASH, multiple acute organ injury, chronic liver diseases and other diseases, ongoing clinical trials of larsucosterol, and the potential benefits of Fast Track Designation. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “planned,” “will,” “may,” “expect,” “anticipate,” and similar expressions are intended to identify these forward-looking statements. These forward-looking statements are based on DURECT’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties that Innocoll may not launch or commercialize POSIMIR successfully, if at all, the risk that the clinical trial of larsucosterol in AH takes longer to conduct than anticipated due to COVID-19 or other factors, the risk that clinical trials of larsucosterol, including AHFIRM, do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy or the lifesaving potential of larsucosterol in a statistically significant manner, the risk that Fast Track Designation for larsucosterol in AH may not lead to faster FDA review or an approval, risks related to DURECT’s ability to obtain capital to fund operations and expenses, risks related to market competition, and other risks described in the “Risk Factors” section of DURECT’s Quarterly Report on Form 10-Q for the period ended September 30, 2021 filed with the Securities and Exchange Commission (the “SEC”) on November 3, 2021, and in other filings filed from time to time with the SEC. DURECT does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, 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. View original content:https://www.prnewswire.com/news-releases/durect-corporation-doses-first-european-patient-in-phase-2b-ahfirm-study-of-larsucosteroldur-928-in-severe-alcohol-associated-hepatitis-301492629.html SOURCE DURECT Corporation | ||
Company Codes: NASDAQ-NMS:DRRX |