DURECT Corporation Announces Q2 2024 Financial Results and Business Update

DURECT Corporation, based in Cupertino, California, has released its financial results for the quarter ending June 30, 2024, along with a crucial business update. The company is primarily focused on advancing the development of larsucosterol for the treatment of alcohol-associated hepatitis (AH). During a recent Type B meeting with the U.S. Food and Drug Administration (FDA), DURECT discussed the design and requirements for a pivotal Phase 3 clinical trial for larsucosterol. The FDA has granted Breakthrough Therapy Designation (BTD) to larsucosterol, a status that could expedite its development and review. James E. Brown, D.V.M., President and CEO of DURECT, expressed optimism regarding the FDA's feedback and outlined plans to initiate the Phase 3 trial by the end of 2024, with topline results anticipated by the second half of 2026. If successful, larsucosterol could become the first FDA-approved treatment for AH.

In a significant milestone, DURECT held a Type B meeting with the FDA in July 2024 to discuss the proposed Phase 3 trial design for larsucosterol in AH. The company aims to provide more details about the trial design after receiving the written minutes from the meeting. Subject to securing sufficient funding, DURECT plans to commence the Phase 3 trial later this year, with topline results expected in 2026.

The Phase 2b AHFIRM trial, which evaluated larsucosterol's safety and efficacy in severe AH patients, was presented at the European Association for the Study of the Liver (EASL) Congress 2024 in Milan, Italy. This marked the first time AHFIRM data were shared at a medical conference. The initial data were announced in 2023.

On the financial front, DURECT reported total revenues of $2.2 million for the second quarter of 2024, with a net loss of $3.7 million. This is an improvement compared to a net loss of $11.2 million for the same period in 2023. As of June 30, 2024, the company's cash, cash equivalents, and investments totaled $15.8 million, down from $29.8 million at the end of 2023. Debt stood at $12.5 million, compared to $16.7 million at the end of 2023.

The company will host an earnings call at 4:30 p.m. Eastern Time today, August 13, 2024, to discuss the financial results and provide a corporate update. The live audio webcast will be available on DURECT's website.

The AHFIRM trial, a Phase 2b randomized, double-blind, placebo-controlled, international study, evaluated the safety and efficacy of larsucosterol in patients with severe AH. The trial enrolled 307 patients across three arms: placebo, larsucosterol 30 mg, and larsucosterol 90 mg. The primary outcome measured was the 90-day incidence of mortality or liver transplantation, while a key secondary endpoint was 90-day survival. Patients were enrolled at sites across the U.S., EU, U.K., and Australia. Topline data for the AHFIRM trial were announced in November 2023. Reflecting AH's severe nature and lack of treatment options, the FDA has granted larsucosterol Fast Track and Breakthrough Therapy Designations.

Alcohol-associated hepatitis (AH) is an acute form of alcohol-associated liver disease (ALD) characterized by severe inflammation and liver cell damage. It often follows a period of heavy drinking and can lead to life-threatening complications such as liver failure and multi-organ failure. There are currently no FDA-approved treatments for AH, and the condition has a high mortality rate. Liver transplantation is an option but is limited by organ availability and high costs.

Larsucosterol, an endogenous sulfated oxysterol and epigenetic modulator, regulates gene expression without altering the DNA sequence. It inhibits DNA methylation, potentially improving cell survival, reducing inflammation, and decreasing lipotoxicity. This mechanism of action supports developing larsucosterol for treating acute organ injury and certain chronic diseases.

DURECT Corporation is a late-stage biopharmaceutical company focused on developing epigenetic therapies targeting dysregulated DNA methylation to treat serious conditions like acute organ injury and cancer. Its lead drug candidate, larsucosterol, is under clinical development for AH and has received Fast Track and Breakthrough Therapy designations from the FDA. The company is also exploring its use in metabolic dysfunction-associated steatohepatitis (MASH) and has an FDA-approved non-opioid analgesic, POSIMIR®, licensed to Innocoll Pharmaceuticals for U.S. distribution.