CUPERTINO, Calif., Feb. 20, 2018 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced it will host a key opinion leader (KOL) call on the treatment of primary sclerosing cholangitis (PSC) on Monday, February 26 at 12:00 p.m. Eastern Time.
The call will feature a presentation by KOL Keith Lindor, MD, who will present an overview of primary sclerosing cholangitis, including an overview of the disease and its progression, current treatment options and the treatment landscape for PSC. He will be available to answer questions at the conclusion of the call.
Dr. Keith Lindor is Senior Advisor to the Provost at Arizona State University (ASU) and a Professor of Medicine at Mayo Clinic. Dr. Lindor joined ASU in January 2012 and is the founding Dean of the College of Health Solutions. Before coming to ASU, he served as Dean of the Mayo Medical School and Chair in the Division of Gastroenterology and Hepatology. He also served as editor-in-chief of Hepatology and president of the American Association for the Study of Liver Diseases (AASLD) in 2016. Dr. Lindor's clinical interests include: cholestatic liver diseases in adults, particularly primary biliary cholangitis and primary sclerosing cholangitis as well as nonalcoholic steatohepatitis (NASH). The primary focus of his research is on clinical trials and means of optimizing the medical management of people with these disorders.
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 PSC. 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.
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, injectable, and transdermal 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. 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.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 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 submission of RBP-7000 will not result in product approval, as well as possible adverse events associated with the use of POSIMIR, REMOXY ER 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, POSIMIR and REMOXY ER will not replicate results from earlier clinical trials. Further information regarding risks related to DUR-928, POSIMIR and REMOXY ER and other risks related to DURECT is included in DURECT's Form 10-Q filed on November 2, 2017 under the heading "Risk Factors."
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SOURCE DURECT Corporation
Matthew J. Hogan, Chief Financial Officer, DURECT Corporation, 408-777-4936