Key Catalyst for U.S. Biopharma Stock on Track for Q4/23
Research Report

Enrollment of 300 patients is now done for the Phase 2b AHFIRM study of DURECT Corp.'s (DRRX:NASDAQ)  larsucosterol in severe alcohol-associated hepatitis, and if results are "strikingly positive" like the Phase 2a data, they could support a new drug application for this compound, reported H.C. Wainwright & Co. analyst Ed Arce in a June 7 research note.

"We regard AHFIRM's topline data readout in Q4/23 as the key clinical milestone for larsucosterol and a potentially transformational catalyst for DURECT shares," Arce wrote.

Potential 479% return

Accordingly, H.C. Wainwright reiterated its Buy rating and $32 per share target price on the California, U.S.-based biopharma, currently trading at about $5.53 per share.

The difference between the target and current prices represents a material possible gain for investors in DURECT, of 479%.

Preparing to advance drug

DURECT is getting ready for accelerated discussions with the U.S. Food and Drug Administration (FDA) given larsucosterol's fast track designation. Also, the biopharma has started planning the commercial launch of this investigative drug in the States.

Multisite, randomized trial

Arce described the design of the Phase 2b AHFIRM study. It is randomized, double blind, placebo controlled and multisite, being conducted in the U.S., Australia, the United Kingdom and European Union.

All 300 enrolled patients have severe alcohol-associated hepatitis as indicated by a Maddrey's Discriminant Function score of 32 or higher and a MELD score between 21 and 30.

Patients are being randomized on a 1:1:1 basis to receive, on day 1 and if still hospitalized, on day 4, up to two intravenous doses of either: larsucosterol 30 mg, larsucosterol 90 mg or placebo plus the standard of care.

The primary efficacy endpoint of the trial measures the 90-day mortality or, as preferred by the FDA, liver transplant in patients who received larsucosterol versus placebo plus standard of care. Secondary endpoints include 28-day survival, frequency of adverse events, scores on prognostic tests like the MELD and the Lille and time required in the intensive care unit.