DRRX DURECT Corporation

1.71
-0.04  -2%
Previous Close 1.75
Open 1.73
52 Week Low 0.9502
52 Week High 3.949
Market Cap $342,986,169
Shares 200,576,707
Float 173,872,663
Enterprise Value $324,297,470
Volume 735,028
Av. Daily Volume 1,124,025
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Upcoming Catalysts

Drug Stage Catalyst Date
POSIMIR
Post-operative pain relief
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
DUR-928
COVID-19 Patients with Acute Liver or Kidney Injury
Phase 2
Phase 2
Phase 2 initiation of dosing announced September 23, 2020.
DUR-928
Alcoholic hepatitis (AH)
Phase 2b
Phase 2b
Phase 2b trial to commence 2H 2020.
DUR-928
Nonalcoholic steatohepatitis (NASH)
Phase 1b
Phase 1b
Phase 1b top-line data released May 26, 2020.
DUR-928
Psoriasis
Phase 2a
Phase 2a
Phase 2 top-line data did not meet endpoints - January 2, 2020.
RBP-7000
Schizophrenia
Approved
Approved
FDA Approval announced July 27, 2018.
Posidur
Post-operative pain relief
CRL
CRL
CRL issued February 12, 2014.

Latest News

  1. CUPERTINO, Calif., Sept. 30, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) announced today that James E. Brown, President, CEO, Michael H. Arenberg, Chief Financial Officer, and Dr. WeiQi Lin, Executive Vice President of R&D will be participating in a fireside chat hosted by Ed Arce of H. C. Wainwright on Monday, October 5, 2020 from 2:30 p.m. to 3:00 p.m. EDT / 11:30 a.m. to noon PDT

    A live webcast of the presentation will be available by accessing https://journey.ct.events/view/e7ded313-1d06-476a-971c-b76dce8a6457

    The live webcast of the presentation will also be available by accessing DURECT's homepage at www.durect.com and clicking on the "Investors" tab. 

    About DURECT Corporation

    DURECT is a biopharmaceutical company committed…

    CUPERTINO, Calif., Sept. 30, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) announced today that James E. Brown, President, CEO, Michael H. Arenberg, Chief Financial Officer, and Dr. WeiQi Lin, Executive Vice President of R&D will be participating in a fireside chat hosted by Ed Arce of H. C. Wainwright on Monday, October 5, 2020 from 2:30 p.m. to 3:00 p.m. EDT / 11:30 a.m. to noon PDT

    A live webcast of the presentation will be available by accessing https://journey.ct.events/view/e7ded313-1d06-476a-971c-b76dce8a6457

    The live webcast of the presentation will also be available by accessing DURECT's homepage at www.durect.com and clicking on the "Investors" tab. 

    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. DUR-928, the company's lead drug candidate is in clinical development for the potential treatment of alcoholic hepatitis (AH), COVID-19 patients with acute liver or kidney injury, and nonalcoholic steatohepatitis (NASH). DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival. DURECT's proprietary drug 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® (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery. For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q filed on August 4, 2020 under the heading "Risk Factors."

    NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation.  Other referenced trademarks belong to their respective owners.  DUR-928 and POSIMIR are investigational drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication.

    Cision View original content:http://www.prnewswire.com/news-releases/durect-corporation-to-participate-in-fireside-chat-at-hc-wainwright-4th-annual-nash-investor-conference-301142361.html

    SOURCE DURECT Corporation

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  2. CUPERTINO, Calif., Sept. 23, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it has dosed the first patient in its randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the safety and efficacy of DUR-928 in hospitalized COVID-19 patients with acute liver or kidney injury. The primary efficacy endpoint is a composite of survival and being free of acute organ failure at Day 28. The company plans to enroll approximately 80 patients in multiple study sites across the U.S.

    "We are excited to have begun dosing DUR-928 in this population of hospitalized COVID-19 patients with the additional complications of acute liver or kidney injury. These patients are at risk of multi-organ failure and death…

    CUPERTINO, Calif., Sept. 23, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced it has dosed the first patient in its randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the safety and efficacy of DUR-928 in hospitalized COVID-19 patients with acute liver or kidney injury. The primary efficacy endpoint is a composite of survival and being free of acute organ failure at Day 28. The company plans to enroll approximately 80 patients in multiple study sites across the U.S.

    "We are excited to have begun dosing DUR-928 in this population of hospitalized COVID-19 patients with the additional complications of acute liver or kidney injury. These patients are at risk of multi-organ failure and death, similar to hospitalized patients with AH," stated James E. Brown, D.V.M., President and CEO of DURECT.  "Based on the positive clinical results of DUR-928 in hospitalized AH patients from our Phase 2a trial and our preclinical data in multi-organ failure models, we believe that DUR-928, in combination with standard of care, has the potential to help these COVID-19 patients."

    About the Phase 2 Trial

    This Phase 2, randomized, double-blind, placebo-controlled, multi-center study is designed to evaluate safety and efficacy of DUR-928 in COVID-19 patients with acute liver or kidney injury. A total of approximately 80 patients are planned to be enrolled into two study treatment groups in a 3:1 (DUR-928: placebo) ratio. Patients will receive a dose of 150 mg of DUR-928 or placebo by intravenous infusion on day 1 and day 4 in combination with standard of care therapy, which will be determined by the principal investigator (PI) at each clinical trial site. The primary efficacy endpoint is a composite of survival and being free of acute organ failure (free of mechanical ventilation, free of liver failure events and free of renal replacement therapy) at day 28. Patients will be followed for 60 days. Should any drug product be determined by the FDA to be safe and effective for the treatment of COVID-19 while the trial is ongoing, such treatments may be offered, at each PI's discretion, to any remaining and future patients in this trial.   For more information, refer to ClinicalTrials.gov Identifier: NCT04447404

    About COVID-19

    COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus (SARS-COV-2). The rapid spread of the disease has resulted in a pandemic with millions of confirmed cases and hundreds of thousands of deaths worldwide. While most cases result in mild symptoms, including fever, cough and shortness of breath, some rapidly progress into acute respiratory distress syndrome (ARDS), multi-organ failure, and death.  Many of these patients experience a rapid elevation of inflammation-inducing signaling molecules (cytokine storm) that trigger acute injuries in multiple organs including the liver and the kidney. Organ injury may also occur in hospitalized COVID-19 patients as the result of other complications of the viral infection. In a study of 1,059 adult cases of confirmed hospitalized COVID-19, 62% of patients presented with at least one elevated liver enzyme. In another study, 36.6% of 5,449 patients admitted with COVID-19 had or developed acute kidney injury (AKI).

    About DUR-928

    DURECT's lead drug candidate, DUR-928, is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival.

    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. DUR-928, the company's lead drug candidate is in clinical development for the potential treatment of alcoholic hepatitis (AH), COVID-19 patients with acute liver or kidney injury, and nonalcoholic steatohepatitis (NASH). DURECT's proprietary drug 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® (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery. For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q filed on August 4, 2020 under the heading "Risk Factors."

    NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation.  Other referenced trademarks belong to their respective owners.  DUR-928 and POSIMIR are investigational drug candidates under development and have 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

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  3. CUPERTINO, Calif., Sept. 22, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced the study design for the Phase 2b AHFIRM clinical trial of DUR-928 in severe alcoholic hepatitis (AH) patients.

    AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study will be comprised of three arms of approximately 100 patients each: (1) DUR-928 (30 mg); (2) DUR-928 (90 mg); and (3) Placebo plus standard of care (SOC). SOC may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician. Patients will receive an intravenous (IV) dose of DUR-928 or placebo (sterile…

    CUPERTINO, Calif., Sept. 22, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced the study design for the Phase 2b AHFIRM clinical trial of DUR-928 in severe alcoholic hepatitis (AH) patients.

    AHFIRM is a randomized, double-blind, placebo-controlled, international, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928 in approximately 300 patients with severe AH. The study will be comprised of three arms of approximately 100 patients each: (1) DUR-928 (30 mg); (2) DUR-928 (90 mg); and (3) Placebo plus standard of care (SOC). SOC may include the use of methylprednisolone, a corticosteroid, at the discretion of the treating physician. Patients will receive an intravenous (IV) dose of DUR-928 or placebo (sterile water) on day 1 and a second IV dose on day 4 if they are still hospitalized. The primary outcome measure will be 90-day survival rate for patients treated with DUR-928 compared to those treated with placebo plus SOC.  Secondary endpoints include 28-day survival, the rate of adverse events, Lille and MELD (prognostic scores) and time in the intensive care unit. The Company is targeting 40-45 clinical trial sites in the US and Europe and anticipates trial initiation in October.

    "We are pleased to announce the design and pending initiation of this important clinical trial," stated James E. Brown, D.V.M., President and CEO of DURECT.  "Following on the very encouraging results from our Phase 2a AH trial, we believe that the Phase 2b AHFIRM trial will provide a robust evaluation of the safety and potential life-saving capacity of DUR-928 in severe AH patients, who desperately need an effective therapy."

    About Alcoholic Hepatitis (AH)

    AH is an acute form of alcoholic liver disease (ALD) associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption. AH is typically characterized by recent onset jaundice and hepatic failure. According to the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were over 117,000 hospitalizations for patients with AH in 2016. From a recent publication analyzing the mortality and costs associated with AH, the cost per patient is estimated at over $50,000 in the first year. ALD is one of the leading causes of liver transplants in the U.S., costing over $800,000 per patient.

    About DUR-928

    DURECT's lead drug candidate, DUR-928, is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival.

    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. DUR-928, the company's lead drug candidate is in clinical development for the potential treatment of alcoholic hepatitis (AH), COVID-19 patients with acute liver or kidney injury, and nonalcoholic steatohepatitis (NASH). DURECT's proprietary drug 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® (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery. For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat AH and other acute organ injuries, including in COVID-19 patients, as well as chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 start of the AHFIRM trial or other trials will be delayed due to COVID-19 or other factors, that the AHFIRM trial will take longer than expected and may not replicate results from earlier trials, that the clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that clinical trials of DUR-928 do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q filed on August 4, 2020 under the heading "Risk Factors."

    NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation.  Other referenced trademarks belong to their respective owners.  DUR-928 and POSIMIR are investigational drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication.

    Cision View original content:http://www.prnewswire.com/news-releases/durect-corporation-announces-design-of-phase-2b-ah-study-ahfirm-301135419.html

    SOURCE DURECT Corporation

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  4. CUPERTINO, Calif., Sept. 10, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced that it will participate in the HC Wainwright 22nd Annual Global Investment Conference, Cantor Fitzgerald Virtual Global Healthcare Conference and Oppenheimer Fall Healthcare Life Sciences & MedTech Summit.

    HC Wainwright 22nd Annual Global Investment Conference

    Date                     Monday, September 14

    Time:                    2:30-2:50 PM EDT (Fireside Chat with Ed Arce)

    Webcast:              https://wsw.com/webcast/hcw7/drrx/1628192

    Cantor Fitzgerald Virtual Global Healthcare Conference

    Date                      Tuesday, September 15

    Time                     10-10:30am EDT (Fireside Chat with Ellie Merle)

    Webcast:              https://www.webcaster4.com/Webcast/Page/2495/37207

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit

    Date:                     Tuesday, September 22

    Time:                    11:40am-12:20pm EDT (Fireside chat with Francois Brisebois)

    Webcast:              https://wsw.com/webcast/oppenheimer5/drrx/2751264

    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. DURECT's lead candidate, DUR-928 is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival. This drug candidate is in clinical development for the potential treatment of alcoholic hepatitis (AH), COVID-19 patients with acute liver or kidney injury, and nonalcoholic steatohepatitis (NASH). DURECT's proprietary drug 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® (bupivacaine solution), an investigational locally-acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery. For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development plans for DUR-928, including the potential use of DUR-928 to treat COVID-19 patients with liver or kidney injury, the potential use of DUR-928 to treat acute organ injuries, such as AH, and chronic liver diseases, such as NASH, and the potential use of POSIMIR to provide pain relief after surgery 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 clinical trial of DUR-928 in COVID-19 patients is delayed or stopped because of changes to the standard of care, the availability of alternative therapies, required protocol changes or lack of available patients, the risk that future clinical trials of DUR-928 are not started when anticipated, take longer to conduct than anticipated, do not confirm the results from earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR or approve POSIMIR with a limited label, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or the Company's other product candidates, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q filed on August 4, 2020 under the heading "Risk Factors."

    NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation.  Other referenced trademarks belong to their respective owners.  DUR-928 and POSIMIR are investigational drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication.

     

    Cision View original content:http://www.prnewswire.com/news-releases/durect-corporation-to-participate-in-september-virtual-investor-conferences-301127214.html

    SOURCE DURECT Corporation

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  5. CUPERTINO, Calif., Aug. 27, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced the presentation of pharmacokinetic (PK) data from a Phase 2a study of DUR-928 in alcoholic hepatitis (AH) at the Digital International Liver Congress™ 2020 (EASL), taking place on August 27-29.  DUR-928 was well tolerated at all doses tested in 19 AH patients, including 12 severe AH patients. These PK data, together with other available information for the drug, have been used to inform dose selection in the Company's upcoming Phase 2b study of DUR-298 in AH, planned to begin in the second half of 2020.   

    DURECT's Phase 2a AH study was an open-label, multi-center, dose escalation safety, PK and pharmacodynamic (PD) trial which evaluated doses…

    CUPERTINO, Calif., Aug. 27, 2020 /PRNewswire/ -- DURECT Corporation (NASDAQ:DRRX) today announced the presentation of pharmacokinetic (PK) data from a Phase 2a study of DUR-928 in alcoholic hepatitis (AH) at the Digital International Liver Congress™ 2020 (EASL), taking place on August 27-29.  DUR-928 was well tolerated at all doses tested in 19 AH patients, including 12 severe AH patients. These PK data, together with other available information for the drug, have been used to inform dose selection in the Company's upcoming Phase 2b study of DUR-298 in AH, planned to begin in the second half of 2020.   

    DURECT's Phase 2a AH study was an open-label, multi-center, dose escalation safety, PK and pharmacodynamic (PD) trial which evaluated doses of 30, 90, or 150 mg of DUR-928 administered by intravenous infusion for 2 hours on Day 1 and Day 4 (if still hospitalized), with patients followed for 28 days.

    Key results presented include:

    • Mean baseline laboratory characteristics and prognostic scores: 
      • Bilirubin 14.2 mg/dL, (upper limit of normal is 1.2 mg/dL)
      • MELD (Model for End-Stage Liver Disease) score 22.3, (≥21 is severe)
      • Maddrey's Discriminant Function 53.4 (≥32 is severe AH)
    • Drug exposure for DUR-928 (as measured by both AUC and Cmax) was dose proportional and comparable between moderate and severe AH patients.  
    • Due to the severe liver injury in AH patients, the systemic clearance of DUR-928 was reduced resulting in an approximately 2-fold higher Cmax in these AH patients compared to healthy subjects.

    As previously reported, DUR-928 was well tolerated at all doses tested. All patients treated with DUR-928 survived through the 28-day follow-up period. Patients treated with DUR-928 had a statistically significant reduction from baseline in bilirubin at days 7 and 28, and in model of end-stage liver disease (MELD) score at day 28. There was a 100% treatment response rate (as defined by Lille score <0.45) in patients receiving 30 or 90 mg doses; and an 89% response rate in all patients.  74% of all DUR-928 treated patients and 67% of those with severe AH were discharged from the hospital within four days after receiving a single dose of DUR-928. There were no drug-related serious adverse events, discontinuations or early withdrawals, or termination of study drug or study participation due to adverse events.

    "We are encouraged by the PK results presented at EASL which demonstrate that DUR-928 was well tolerated at all doses tested in AH patients and contributed to the dose selection in our upcoming Phase 2b AH trial, which we look forward to initiating in the upcoming months," stated James E. Brown, D.V.M., President and CEO of DURECT.

    About the DUR-928 Alcoholic Hepatitis Phase 2a Trial 

    This open-label, dose escalation, multi-center study was designed to determine the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of DUR-928 in AH patients following treatment. This included assessing liver biochemistry, biomarkers, and prognostic scores such as the Lille score. Final enrollment included 19 patients with moderate and severe AH, who were administered DUR-928 intravenously at three different doses. Eight patients (four moderate and four severe) were dosed at 30mg, seven patients (three moderate and four severe) were dosed at 90mg and four patients (all severe) were dosed at 150mg. For more information, refer to ClinicalTrials.gov identifier: NCT03432260.

    DUR-928: next steps in alcoholic hepatitis

    DURECT is finalizing its preparations to initiate a multi-center, international, randomized, double blind, placebo-controlled Phase 2b clinical trial of DUR-928 in severe AH patients later this year. Based on these results and other information generated during the program, the 30 and 90 mg doses have been selected for this next study. The primary endpoint will be survival rate for patients treated with DUR-928 compared to those treated with placebo. Further details of the trial design, including the size of the trial and other trial parameters will be provided at a future date.

    About Alcoholic Hepatitis (AH)

    AH is an acute form of alcoholic liver disease (ALD), associated with long-term heavy intake of alcohol, and often occurs after a recent period of increased alcohol consumption. AH is typically characterized by recent onset jaundice and hepatic failure. An analysis of 77 studies published between 1971 and 2016, which included data from a total of 8,184 patients, showed the overall mortality from AH was 26% at 28 days. According to the most recent data provided by the Agency for Healthcare Research and Quality (AHRQ), a part of the US Department of Health and Human Services (HHS), there were over 117,000 hospitalizations for patients with alcoholic hepatitis in 2016. From a recent publication analyzing the mortality and costs associated with alcoholic hepatitis, the cost per patient is estimated at over $50,000 in the first year. Liver transplantation usually involves a long waiting period, a burdensome selection process and a costly procedure over $800,000.

    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. DURECT's lead candidate, DUR-928 is an endogenous sulfated oxysterol and an epigenetic regulator. It represents a new class of therapeutics with a unique mechanism of action. DUR-928 epigenetically modulates the expression of multiple clusters of master genes that are involved in many important cell signaling pathways, through which it stabilizes mitochondria, reduces lipotoxicity, regulates inflammatory or stress responses, and promotes cell survival. This drug candidate is currently in Phase 2 development for the treatment of alcoholic hepatitis (AH) and the treatment of COVID-19 patients with acute liver or kidney injury as well as Phase 1 development for the treatment of nonalcoholic steatohepatitis (NASH). DURECT's proprietary drug 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® (bupivacaine extended-release solution), an investigational locally-acting, non-opioid analgesic intended to provide up to three days of continuous pain relief after surgery. For more information about DURECT, please visit www.durect.com and follow us on Twitter https://twitter.com/DURECTCorp.

    DURECT Forward-Looking Statement

    The statements in this press release regarding clinical development and plans for DUR-928, including initiating a Phase 2b trial of DUR-928 in AH in the second half of 2020, and the potential benefits and uses of our drug candidates, including the potential use of DUR-928 to treat acute organ injuries such as AH and COVID-19 patients with acute liver or kidney injury as well as chronic liver diseases such as NASH, and the use of POSIMIR to treat pain after surgery, 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 future clinical trials of DUR-928 are not started or finalized when anticipated, take longer to conduct than anticipated, do not generate similar positive results as generated in earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of DUR-928 in a statistically significant manner, the risk that the FDA will not approve POSIMIR, the risk of disruptions to our business operations resulting from the COVID-19 pandemic, the risk that additional time and resources may be required for development, testing and regulatory approval of DUR-928 or POSIMIR, potential adverse effects arising from the testing or use of our drug candidates, our potential failure to maintain our collaborative agreements with third parties or consummate new collaborations and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT's Form 10-Q filed on August 4, 2020 under the heading "Risk Factors."

    NOTE: POSIMIR® and SABER® are trademarks of DURECT Corporation.  Other referenced trademarks belong to their respective owners.  DUR-928 and POSIMIR are investigational drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication.

    Cision View original content:http://www.prnewswire.com/news-releases/durect-corporation-announces-presentation-of-phase-2a-pharmacokinetic-data-of-dur-928-in-alcoholic-hepatitis-at-digital-international-liver-congress-easl-301119558.html

    SOURCE DURECT Corporation

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