• 15 Nov 2021
• Admin
• News Article

Durect Corporation Doses First Ex Us Patient In Phase 2B Ahfirm Study Of Larsucosterol (Dur-928) In Severe Alcohol Associated Hepatitis

Durect Corporation (Nasdaq: Drrx) Today Announced It Dosed The First Ex-U.S. Patient In Australia 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."Ah Is A Global Condition And We Are Excited To Have Started Dosing Severe Ah Patients In The Ahfirm Trial Outside Of The United States. We Recently Opened The First Ex-U.S. Clinical Trial Sites In Australia And Are Pleased That The First Australian Subject Has Now Been Dosed," Stated James E. Brown, D.V.M., President And Ceo Of Durect. "We Continue Working To Open 60 Or More Clinical Trial Sites Across The U.S., Australia, Eu, And U.K."About The Ahfirm TrialEnrollment Is Ongoing In Our Phase 2B Randomized, Double-Blind, Placebo-Controlled, International, Multi-Center Study In Subjects With Severe Acute Alcohol-Associated Hepatitis (Ah) To Evaluate Safety And Efficacy Of Larsucosterol (Dur-928) Treatment (Ahfirm). The Study Is Comprised Of Three Arms Targeting Enrollment Of 300 Total Patients, With Approximately 100 Patients In Each Arm: (1) Placebo Plus Standard Of Care (Soc) Which May Include The Use Of Methylprednisolone, A Corticosteroid, At The Discretion Of The Treating Physician); (2) Larsucosterol (30 Mg); And (3) Larsucosterol (90 Mg). All Patients In The Trial Receive Supportive Care. The Primary Outcome Measure Is 90-Day Survival Rate For Patients Treated With Larsucosterol Compared To Those Treated With Placebo Plus Soc. The Company Is Targeting More Than 60 Clinical Trial Sites Across The U.S., Eu, U.K., And Australia. Reflecting The Life-Threatening Nature Of Ah And The Lack Of Therapeutic Options, The U.S. Food And Drug Administration (Fda) Has Granted Larsucosterol Fast Track Designation For The Treatment Of Ah. We Believe Demonstration Of A Robust Survival Benefit In The Ahfirm Trial Would Support An Nda Filing. For More Information, Refer To Clinicaltrials.Gov Identifier: Nct04563026.About Alcohol-Associated Hepatitis (Ah)Ah Is A Life-Threatening Acute Alcohol-Associated Liver Disease (Ald) Often Caused By Chronic Heavy Alcohol And A Recent Period Of Increased Alcohol Consumption (E.G., A Binge). It Is Characterized By Severe Inflammation And Destruction Of Liver Tissue (I.E., Necrosis), Potentially Leading To Life-Threatening Complications, Including Liver Failure, Acute Renal Injury And Multi-Organ Failure. There Are No Fda Approved Therapies For Ah And The Overall Average Mortality Of Ah Patients In Clinical Trials Has Been Reported To Be 26% At 28 Days, 29% At 90 Days And 44% At 180 Days. Stopping Alcohol Consumption Is Not Sufficient For Recovery In Many Moderate And Severe Patients And The Use Of Treatments To Reduce Liver Inflammation, Such As Corticosteroids, Are Limited By Contraindications And Have Been Shown To Provide No Survival Benefit At 90 Days Or 1 Year. While Liver Transplantation Is Becoming More Common For Alcoholic Liver Disease Patients, Including For Ah Patients, The Procedure Involves A Long Waiting Period, A Burdensome Selection Process And Costs More Than $875,000 On Average.About Durect CorporationDurect 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. Larsucosterol (Also Known As Dur-928), The Company'S Lead Drug Candidate, Binds To And Inhibits The Activity Of Dna Methyltransferases (Dnmts), Epigenetic Enzymes Which Are Elevated And Associated With Hypermethylation Found In Ah Patients. Larsucosterol Is In Clinical Development For The Potential Treatment Of Alcohol-Associated Hepatitis (Ah) For Which Fda Has Granted A Fast Track Designation; Non-Alcoholic Steatohepatitis (Nash) Is Also Being Explored. In Addition, Posimir