DURECT to Host Key Opinion Leader Call on DUR-928 Phase 2a Alcoholic Hepatitis Study Results
Call will feature data from DURECT’s late-breaking oral presentation at the 2019 Liver Meeting®
CUPERTINO, Calif., Nov. 6, 2019 /PRNewswire/ — DURECT Corporation (Nasdaq: DRRX) announced today that it will host a key opinion leader (KOL) conference call and live webcast to discuss the results of its recently completed Phase 2a clinical trial of DUR-928 in patients with alcoholic hepatitis (AH) on Tuesday, November 12 at 12:00 noon EST. The call will feature a review of the late-breaking oral presentation that Tarek I. Hassanein, M.D. will deliver at The Liver Meeting® 2019 at 8:30 a.m. EST on Tuesday, November 12.
Dial-In and Webcast Information Tuesday, November 12 at 12 noon EST Domestic (Free): 1-877-407-0784 Toll / International: 1-201-689-8560 Conference ID: 13696593 Webcast with slides: http://public.viavid.com/index.php?id=137023
A replay of the webcast and data slide presentation will be available on the Investor section of the DURECT website at https://investors.www.durect.com/ after the call.
Dr. Tarek I. Hassanein is one of the investigators of the Phase 2a AH clinical trial and is board-certified in internal medicine, gastroenterology and transplant hepatology. He is currently a professor of medicine and director of outreach services for liver transplantation at the School of Medicine, University of California San Diego (UCSD). He has been instrumental in establishing three major liver transplantation programs. Dr. Hassanein established the Southern California Liver Centers in 2009 to care for patients with advanced and complicated liver diseases, including alcoholic hepatitis, liver cancer, HCV and cirrhosis. He is also the director of the Southern California Research Center, medical director of UCSD Sharp Liver Transplant Outreach Program and chief of gastroenterology and hepatology at Sharp Coronado Hospital in Coronado, California. Dr. Hassanein has been the principal investigator on multiple international trials and has authored numerous publications. Dr. Hassanein earned his medical degree from Alexandria University in Alexandria, Egypt. He completed his residency training at Wayne State University in Detroit, Michigan, and a research fellowship and a clinical fellowship in gastroenterology, hepatology and transplantation at the University of Pittsburgh School of Medicine.
About the DUR-928 Alcoholic Hepatitis Phase 2a Trial Patients with moderate and severe AH were treated with DUR-928, administered intravenously, in this open label, dose escalation multi-center U.S., Phase 2a clinical trial. Final enrollment was 19 patients and comprised of: 8 patients (4 moderate and 4 severe) dosed at 30 mg, 7 patients (3 moderate and 4 severe) dosed at 90 mg and 4 patients (4 severe) dosed at 150 mg. The study objectives included assessment of safety, pharmacokinetics (PK) and pharmacodynamic (PD) signals, including liver chemistry and biomarkers.
About DURECT Corporation DURECT is a biopharmaceutical company actively developing therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms. DUR‑928, a new chemical entity in Phase 2 development, is the lead candidate in DURECT’s Epigenetic Regulator Program. An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival. Human applications may include acute organ injury such as AH and acute kidney injury (AKI), chronic hepatic diseases such as NASH, and inflammatory skin conditions such as psoriasis and atopic dermatitis. DURECT’s advanced oral and injectable delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. Key product candidates in this category include POSIMIR® (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery, and a long-acting injectable SABER-based HIV investigational product being developed with Gilead. For more information about DURECT, please visit www.www.durect.com.
DURECT Forward-Looking Statement The statements in this press release regarding the potential benefits and uses of DURECT’s drug candidates, including, but not limited to, the potential use of DUR-928 to treat AH, hepatic and renal diseases such as NASH and AKI, and inflammatory skin conditions such as psoriasis and atopic dermatitis, the potential use of POSIMIR to treat post-operative pain, planned clinical trial announcements for the Phase 2a trial of DUR-928 in psoriasis in 2019, and the potential development of a long-acting injectable SABER-based HIV product with Gilead and associated potential payments to DURECT are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risk of delays in clinical trials or adverse safety events from patients administered with DUR-928, the risk that the ongoing clinical trials of DUR-928 in NASH or psoriasis do not successfully achieve their endpoints, the risk that placebo controlled studies of DUR-928 required for regulatory approval will not replicate results from open label clinical trials or trials with small numbers of patients or historical controls, the risks that the long-acting injectable SABER-based HIV investigational product being developed with Gilead will not succeed or that Gilead will abandon this program, the risk that the FDA Advisory Committee will not recommend approval of POSIMIR or that the FDA will not approve POSIMIR, and the risk of delays and costs due to additional work or other requirements imposed by regulatory agencies for continued development, approval or sale of any of our product candidates. Further information regarding these and other risks related to DURECT is included in DURECT’s Form 10-Q filed on November 5, 2019 under the heading “Risk Factors” and in subsequent reports that we file with the Securities and Exchange Commission.
NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation. DUR-928 and POSIMIR are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.
Corporate Contact: Mike Arenberg, DURECT, Chief Financial Officer, +1-408-346-1052, firstname.lastname@example.org, or Media Contact: Alison Chen, LifeSci Public Relations, +1-646-876-4932, email@example.com
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