In a March 15 research note, H.C. Wainwright & Co. analyst Ed Arce provided an update on DURECT Corp.'s (DRRX:NASDAQ) DUR-928 and Posimir as well as Q4/20 financial numbers.
Regarding DUR-928, the first patient was dosed for the biopharma's Phase 2b AHFIRM trial in patients with severe alcohol-associated hepatitis (AH), and the company "is now primarily focused on the trial's successful execution in 2021," reported Arce.
He reiterated AHFIRM's design and endpoints. The trial will be conducted at about 40–50 clinical sites in the U.S. and European Union, and total enrollment will be 300 patients. To achieve that number, this year DURECT will focus on opening additional study sites.
For the trial, patients will be randomized on a 1:1:1 basis to receive, on day one and, if still hospitalized, on day four, two intravenous doses of either: DUR-928 30 milligrams, DUR-928 90 milligrams or placebo plus AH standard of care, which could include methylprednisolone if believed warranted by the treating physician.
The primary endpoint is the 90-day survival rate of patients treated with DUR-928 versus placebo plus standard of care. Secondary endpoints are survival rate at 28 days, frequency of adverse events, Lille and Model for End-Stage Liver Disease, or MELD, scores and time spent in the Intensive Care Unit.
As for a potential timeline regarding DUR-928 in AH, H.C. Wainwright expects AHFIRM enrollment to be completed in about 12 months or in Q1/22, with topline trial data released in about Q3/22. If the data show a clear survival benefit, they could support DURECT's filing of a new drug application for DUR-928 in this indication. Should that occur, the U.S. Food and Drug Administration (FDA) could approve the drug in H1/23.
The analyst noted that an article in the peer-reviewed Journal of Lipid Research explained DUR-928's mechanism of action as an epigenetic regulator. It indicated that the drug inhibits the activity of DNA methyltransferases 1, 3a and 3b that regulate the expression of genes responsible for cellular activities, such as cell death and lipid biosynthesis. As such, DUR-928 could regulate various correlated processes, such as lipid accumulation and inflammation, symptoms tied to AH and nonalcoholic steatohepatitis, or NASH.
Regarding another of DURECT's drugs, Posimir, the FDA approved it earlier this month as postsurgical analgesia in adults who undergo arthroscopic subacromial decompression, Arce relayed. The biopharma is looking to market Posimir in the U.S. through a commercial partnership, yet to be formed.
Arce recapped DURECT's financial performance in Q4/20. The company had a Q4/20 net loss, of $8.8 million. It generated $2.2 million, including $1.9 million from sales of its legacy products, and at year-end 2020, DURECT had $56.9 million in cash and cash equivalents. More recently, this February, it raised $47.8 million in an equity offering.
H.C. Wainwright has a Buy rating and a $6 per share target price on DURECT, the stock of which is trading now at about $2.26 per share.
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