On May 4, 2022 DURECT Corporation (Nasdaq: DRRX) reported financial results for the three months ended March 31, 2022 and provided a corporate update (Press release, DURECT, MAY 4, 2022, View Source [SID1234613523]).
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"Progress continues in the larsucosterol (DUR-928) AHFIRM trial, with more patients dosed in the first quarter of 2022 than in any prior quarter, reflecting the opening of additional clinical trial sites and our ongoing efforts to work with existing sites to recruit more patients with severe alcohol-associated hepatitis (AH) that meet our enrollment criteria," stated James E. Brown, D.V.M., President and CEO of DURECT.
First Quarter and Recent Business Highlights:
Continued progress in AHFIRM enrollment – DURECT has now dosed the first patients in Australia, France and Belgium, with 57 AHFIRM study sites now open at leading hospitals in the U.S., Australia, E.U. and U.K., a net increase of 6 sites in the two months since our last earnings call. At the pace of enrollment achieved in the first quarter of 2022, we would complete dosing the last patient in the AHFIRM trial in mid-2023; we expect the pace of enrollment should improve through our clinical site expansion, clinical trial engagement activities and the potential lessening of the impact of COVID on the hospitals participating in AHFIRM.
Engaging thought leaders and increasing awareness of AH – DURECT’s medical affairs team has been substantially increasing our AH market outreach and education efforts to amplify larsucosterol awareness and facilitate AHFIRM enrollment efforts. We have recently hosted the first of multiple regional AHFIRM study update meetings with our investigators and study site coordinators, sponsored and exhibited at three liver-focused congresses in person, and retained a medical communications agency to broaden awareness of AH, the AHFIRM trial and larsucosterol.
Approaching U.S. launch of POSIMIR by our licensee – DURECT signed an exclusive U.S. licensing agreement for POSIMIR with Innocoll Pharmaceuticals in December 2021. Under the agreement, DURECT will earn low to mid double-digit royalties from net sales of POSIMIR and is eligible to receive up to $136 million in upfront and milestone payments, including the $4 million upfront license fee received in January 2022, and a $2 million milestone payment upon the first commercial sale of POSIMIR, which is anticipated in Q2 2022.
Financial highlights for Q1 2022:
Total revenues were $1.9 million and net loss was $10.8 million for the three months ended March 31, 2022 compared to total revenues of $2.2 million and net loss of $10.1 million for the three months ended March 31, 2021.
At March 31, 2022, cash and investments were $64.4 million, compared to cash and investments of $70.0 million at December 31, 2021. Debt at March 31, 2022 was $20.8 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 first quarter 2022 results and provide a corporate update:
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 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 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 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, 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 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 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 AH patients, the procedure involves a long waiting period, a burdensome selection process, and costs more than $875,000 on average.
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.