DURECT Corporation to Host Key Opinion Leader Call on Alcoholic Hepatitis
CUPERTINO, Calif., March 29, 2018 /PRNewswire/ — DURECT Corporation (Nasdaq: DRRX) today announced it will host a key opinion leader (KOL) call on the treatment of alcoholic hepatitis (AH) on Thursday, April 5 at 11:00 a.m. Eastern Time.
The call will feature a presentation by KOL Paul Kwo, MD, who will present an overview of alcoholic hepatitis, including an overview of the disease and its progression, current treatment options and new treatments in development for alcoholic hepatitis. Dr. Kwo will be available to answer questions at the conclusion of the call.
DURECT’s management team will also provide an overview of the Company’s ongoing clinical development program for DUR-928, including a summary of preclinical and clinical data disclosed to-date and a review of the Company’s Phase 2 study in patients with alcoholic hepatitis. DUR-928 is the lead product candidate in DURECT’s Epigenetic Regulator Program. It is an endogenous, first-in-class small molecule that has been shown in nonclinical studies to modulate the activity of nuclear receptors playing an important regulatory role in lipid homeostasis, inflammation, and cell survival.
Dr. Paul Kwo is currently Professor of Medicine of Gastroenterology and Hepatology, and Director of Hepatology at Stanford University where he joined the faculty in November 2016. Prior to joining the faculty at Stanford, he was at Indiana University for 21 years where he served as the Medical Director of Liver Transplantation. He has distinguished himself in the field of Hepatitis C therapeutics and has been the principal investigator on multiple international trials. He recently authored the ACG Clinical Guideline: Evaluation of Abnormal Liver Chemistries. Dr. Kwo has extensively published on the topics of the management and treatment of hepatitis B and C and liver transplant. He is currently on the Editorial Board of the Journal of Clinical Gastroenterology, and an active committee member for the American Association for the Study of Liver Diseases (AASLD).
Dial-In & Webcast Information
Thursday, April 5 @ 11:00 am Eastern Time / 8:00 am Pacific Time
About DURECT DURECT is a biopharmaceutical company actively developing new 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, hepatic and renal diseases such as nonalcoholic steatohepatitis (NASH) and PSC, 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. One late-stage product candidate in this category is POSIMIR® (SABER®-Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery. Another late stage product candidate is REMOXY® ER (oxycodone), an investigational pain control drug based on DURECT’s ORADUR® technology, for which the FDA has set a PDUFA target action date of August 7, 2018. In addition, for the assignment of certain patent rights, DURECT may receive a milestone payment upon NDA approval and single digit sales-based earn-out payments from U.S. net sales of Indivior’s RBP-7000 investigational drug for schizophrenia, for which Indivior has submitted an NDA and for which the FDA has set a PDUFA target action date of July 28, 2018. For more information, please visit www.www.durect.com.
DURECT Forward-Looking Statement The statements in this press release regarding the KOL call, the potential benefits and uses of drug candidates, including the potential use of DUR-928 to treat alcoholic hepatitis, PSC, NASH and other hepatic and renal diseases, acute organ injury or inflammatory skin conditions such as psoriasis and atopic dermatitis, POSIMIR to treat post-surgical pain, REMOXY ER to treat pain, Indivior’s RBP-7000 to treat schizophrenia, and the potential milestone payment and earn-out payments receivable from Indivior, 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 risks that the NDA submissions of RBP-7000 and REMOXY ER will not result in product approvals, as well as possible adverse events associated with the use of POSIMIR, REMOXY ER, RBP-7000 and DUR-928, delays and costs due to additional work or other requirements imposed by regulatory agencies for continued development, approval or sale of POSIMIR, REMOXY ER and DUR-928, and the possibility that studies of DUR-928 and POSIMIR will not replicate results from earlier clinical trials. Further information regarding risks related to DUR-928, POSIMIR, REMOXY ER and RBP-7000 and other risks related to DURECT is included in DURECT’s Form 10-K filed on March 8, 2018 under the heading “Risk Factors.”