H.C. Wainwright has maintained a Neutral stance on Durect Corp (NASDAQ: NASDAQ:DRRX) after the company revealed plans for a Phase 3 trial of larsucosterol.
The trial, designed to assess the treatment of severe alcohol-associated hepatitis (AH), follows guidance obtained from the FDA under the Breakthrough Therapy designation.
The upcoming registrational Phase 3 trial will be conducted exclusively in the U.S. and aims to determine the safety and efficacy of larsucosterol.
The study is a randomized, double-blind, placebo-controlled trial targeting a primary endpoint of 90-day survival. It also includes an extended observation period of up to 180 days to collect further safety and outcomes data. Approximately 200 patients are expected to be enrolled and will be randomly assigned to receive either a 30 mg dose of larsucosterol or a placebo. This will be in conjunction with the current standard of care, which may include methylprednisolone at the discretion of the investigators.
The announcement comes after Durect's recent engagement with the FDA, which provided input for the trial's design. The focus on a 90-day survival endpoint reflects the critical nature of treating severe AH, a condition with significant mortality rates.
The additional 180-day follow-up is intended to provide a comprehensive view of the drug's safety profile and longer-term effects.
Durect's commitment to advancing the treatment of severe AH with larsucosterol is underscored by the meticulous planning of the Phase 3 trial. The decision to proceed with only U.S. sites could streamline the study and focus resources on a targeted patient population.
The trial's design, which allows for the inclusion of the current standard of care, reflects a pragmatic approach to evaluating larsucosterol's potential benefits in a real-world setting.
In other recent news, DURECT Corporation reported a slight increase in total revenues for the second quarter of 2024 with $2.2 million. The company also announced its plans to initiate a Phase III clinical trial for larsucosterol, a potential treatment for alcohol-associated hepatitis (AH). DURECT's financial status remains stable with $15.8 million in cash and investments, expected to fund operations through 2024. On the downside, the company reported a quarterly burn rate of $5.8 million, with $2.1 million allocated to debt service.
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