On November 2, 2022 DURECT Corporation (Nasdaq: DRRX) reported financial results for the three months ended September 30, 2022 and provided a corporate update (Press release, DURECT, NOV 2, 2022, View Source [SID1234622800]).
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"We are excited that we are now on track to complete enrollment of our pivotal AHFIRM trial in the second quarter of 2023, earlier than we previously estimated. We continue to make excellent progress toward our goal of bringing larsucosterol to market as the first FDA-approved treatment for alcohol-associated hepatitis," stated James E. Brown, D.V.M., President and CEO of DURECT. "In addition, we earned $10 million in total milestone payments from our Innocoll collaboration. We are pleased that Innocoll has launched POSIMIR and look forward to following their launch progress."
Third Quarter and Recent Business Highlights:
Continued progress in AHFIRM enrollment – DURECT has enrolled more than 200 patients in the AHFIRM trial to date, which exceeds two-thirds of the target enrollment for the 300-patient trial. We have over 60 AHFIRM study sites open at leading hospitals in the U.S., Australia, E.U. and U.K. and are continuing to open new sites, including prominent transplant centers. We currently expect to complete enrollment in the AHFIRM trial in the second quarter of 2023, which should enable top-line results to be reported in the second half of 2023.
Commercial launch of POSIMIR – In September 2022, Innocoll Pharmaceuticals Limited (Innocoll) commercially launched and achieved the first sales of POSIMIR in the United States, triggering a $2 million milestone for DURECT. In August 2022, DURECT was issued a new patent by the US Patent Office, extending US patent coverage for POSIMIR to at least 2041. This event triggered an $8 million milestone payment which was received by DURECT during the third quarter.
Financial Highlights for Q3 2022:
Total revenues were $12.0 million and net loss was $2.5 million for the three months ended September 30, 2022 compared to total revenues of $2.2 million and net loss of $10.0 million for the three months ended September 30, 2021.
At September 30, 2022, cash and investments were $52.0 million, compared to cash and investments of $70.0 million at December 31, 2021. Total debt at September 30, 2022 was $21.0 million, compared to $20.6 million at December 31, 2021.
Earnings Conference Call
We will host a conference call today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss third quarter 2022 results and provide a corporate update:
Wednesday, November 2 @ 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time
Toll Free:
1-877-869-3847
International:
201-689-8261
Conference ID:
13733742
Webcast:
A live audio webcast of the presentation will be also available by accessing DURECT’s homepage at www.durect.com and clicking "Investors." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under "Event Calendar" in the "Investors" section.
About the AHFIRM Trial
Enrollment 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 supportive care, with or without methylprednisolone capsules at the investigators’ discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms receive the same supportive care without steroids. In order to maintain blinding, patients in the two active arms receive matching placebo capsules if the investigator prescribes steroids. The primary outcome measure will be the 90-Day incidence of mortality or liver transplantation for patients treated with larsucosterol compared to those treated with placebo. The Company is enrolling patients at 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 a positive outcome in the AHFIRM trial could support a New Drug Application 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 use and a recent period of increased alcohol consumption (i.e., 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 a retrospective 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, 29% at 90 days and 44% at 180 days. A subsequent global study published in December 2021, which included 85 tertiary centers in 11 countries across 3 continents, prospectively enrolled 2,581 AH patients with a median Model of End-Stage Liver Disease (MELD) score of 23.5, reported mortality at 28 and 90 days of 20% and 31%, respectively. Stopping alcohol consumption is not sufficient for recovery in many moderate (defined as MELD scores of 11-20) and severe (defined as MELD scores >20) 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 ALD patients, including AH patients, the procedure often involves a long waiting period, a burdensome selection process, costs exceeding $875,000 on average, and patients requiring lifelong immunosuppressive therapy to prevent organ rejection.
About Larsucosterol (DUR-928)
Larsucosterol is an endogenous sulfated oxysterol and an epigenetic regulator. Epigenetic regulators are compounds that regulate patterns of gene expression without modifying the DNA sequence. DNA hypermethylation, an example of epigenetic dysregulation, results in transcriptomic reprogramming and cellular dysfunction, and has been found to be associated with many acute (e.g., AH) or chronic diseases (e.g., NASH). As an inhibitor of DNA methyltransferases (DNMT1, DNMT3a and 3b), larsucosterol inhibits DNA methylation, which subsequently regulates expression of genes that are involved in cell signaling pathways associated with stress responses, cell death and survival, and lipid biosynthesis. This may ultimately lead to improved cell survival, reduced inflammation, and decreased lipotoxicity. As an epigenetic regulator, the proposed mechanism of action provides further scientific rationale for developing larsucosterol for the treatment of acute organ injury and certain chronic diseases.