DURECT Corporation Q1 2024 Financial Results and Business Update

On May 13, 2024, DURECT Corporation released its financial results for the first quarter ending March 31, 2024. The company also shared significant updates on the clinical advancement of larsucosterol, its lead drug candidate for treating alcohol-associated hepatitis (AH).

FDA Endorsement for Larsucosterol Trial
James E. Brown, D.V.M., President and CEO of DURECT, expressed satisfaction with the U.S. Food and Drug Administration (FDA) feedback, which supports moving forward with a single pivotal Phase 3 clinical trial for larsucosterol. If successful, this trial could serve as the foundation for a New Drug Application (NDA) in AH. The trial design is currently being refined, integrating FDA recommendations and insights from the company's earlier Phase 2b AHFIRM trial. Brown also mentioned the upcoming presentation of AHFIRM data at the European Association for the Study of the Liver (EASL) Congress 2024, marking the first time this data will be presented at a medical conference.

Larsucosterol's Clinical Journey
The Phase 2b AHFIRM trial was a randomized, double-blind, placebo-controlled study conducted internationally. It enrolled 307 patients with severe AH across three groups: a placebo group receiving standard care, a group administered 30 mg of larsucosterol, and another receiving 90 mg of larsucosterol. The main goal was to compare the 90-day incidence of death or liver transplantation between the larsucosterol and placebo groups. The secondary objective was to assess 90-day survival rates.

Given the urgent need for effective AH treatments and the life-threatening nature of the condition, the FDA has granted larsucosterol Fast Track Designation. This designation is intended to expedite the drug's development and review, recognizing its potential to address an unmet medical need.

Financial Performance
For the quarter ending March 31, 2024, DURECT reported total revenues of $1.8 million and a net loss of $7.6 million. This compares to total revenues of $2.1 million and a net loss of $12.0 million for the same period in 2023. The company's cash, cash equivalents, and investments totaled $21.6 million as of March 31, 2024, down from $29.8 million at the end of December 2023. Debt decreased from $16.7 million at the end of 2023 to $14.6 million.

Upcoming Earnings Call
DURECT plans to host a conference call and webcast on May 13, 2024, at 4:30 p.m. Eastern Time to discuss its first-quarter results and provide a corporate update. The live audio webcast will be accessible via DURECT's website, and an archived version will be available post-call.

Larsucosterol's Mechanism of Action
Larsucosterol functions as an epigenetic modulator, specifically inhibiting DNA methyltransferases (DNMT1, DNMT3a, and DNMT3b). These enzymes are associated with DNA hypermethylation, which leads to cellular dysfunction. By inhibiting these enzymes, larsucosterol aims to regulate gene expression patterns associated with cell survival, inflammation, and lipid biosynthesis. This action could potentially result in enhanced cell survival, reduced inflammation, and decreased lipotoxicity.

Alcohol-Associated Hepatitis: A Critical Health Challenge
AH is a severe form of alcohol-associated liver disease characterized by significant liver inflammation and cell damage, which can lead to life-threatening complications like liver failure and multi-organ failure. Currently, no FDA-approved therapies exist for AH, and the condition carries high mortality rates. Effective treatment options are urgently needed, especially since stopping alcohol consumption alone is often insufficient for recovery in many patients.

About DURECT Corporation
DURECT is a late-stage biopharmaceutical company focusing on developing epigenetic therapies to treat severe and life-threatening conditions, including acute organ injury and cancer. Besides larsucosterol, DURECT has developed POSIMIR® (bupivacaine solution) for infiltration use, an FDA-approved non-opioid analgesic.

DURECT's commitment to advancing larsucosterol for AH treatment and other potential indications underscores its mission to transform therapeutic approaches for critical health conditions.

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