DURECT Corp. is a biopharmaceutical company focused on two areas of active drug development: New therapeutics based on its proprietary drug delivery platforms and new chemical entities derived from its epigenomic regulator program. Its drug development expertise is being applied primarily to the fields of pain management, central nervous system disorders, acute organ injury and metabolic diseases such as nonalcoholic fatty liver disease/nonalcoholic steatohepatitis. Late-stage development programs include POSIMIR (SABER-bupivacaine) and REMOXY (ORADUR-oxycodone). DURECT's epigenomic regulator program includes the lead molecule DUR-928 in Phase 1 development. DUR-928 is an endogenous small molecule that modulates lipid homeostasis, inflammation and cell survival.

Expert Comments:

The company received approval to proceed with the next and final dose level.
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Ed Arce, H.C. Wainwright & Co.

"Yesterday, DURECT Corp. announced that dosing has been completed in the 90 mg cohort of severe alcoholic hepatitis (AH) patients in the ongoing Phase 2a trial of DUR-928. . .the trial's dose escalation committee approved the initiation of the final 150 mg dosing cohort in severe AH patients upon a review of safety and pharmacokinetic data gathered from the completed cohorts so far."

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Brian Marckx, Zacks Small-Cap Research

"Preliminary data from DURECT Corp.'s DUR-928 Phase 2a trial in alcoholic hepatitis on the first 10 patients (eight 30 mg: four moderate, four severe, and two 90 mg: one moderate, one severe) was reported on May 7. Results, in our opinion, are highly compelling, indicating potentially potent efficacy signal and lack of toxicity." — -Zacks Small-Cap Research

Francois Brisebois, Laidlaw & Company

"DURECT Corp. recently reported its Q1/19, very much in line with expectations with earnings per share of $0.04 as anticipated. . .we are encouraged by the company's clinical timeline remaining on track. It continues to expect its Phase 2 open label dose-escalation trial in alcoholic hepatitis and its Phase 1b open-label trial in nonalcoholic steatohepatitis, as well as its Phase 2a double-blind, vehicle-controlled proof of concept in psoriasis, to read out in H2/19."

The results compare favorably to those of the historical control group.
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Ed Arce, H.C. Wainwright & Co.

"Yesterday, DURECT Corp. hosted a key opinion leader session. . .a preliminary data analysis of 10 patients with alcoholic hepatitis (AH) in the ongoing open-label, dose escalation Phase 2a trial of lead drug DUR-928 showed meaningful improvements in key AH disease metrics: the Lille model, model of end-stage liver disease and bilirubin level."

Ed Arce, H.C. Wainwright & Co.

"Recently, on March 27, 2019, DURECT Corp. announced that it began enrollment for a Phase 1b dose-finding trial in nonalcoholic steatohepatitis. . .the company plans to report all data gathered in patients who have completed the trial in an initial data readout in H2/19, including imaging data. Therefore, positive results from this Phase 1b trial could enable the initiation of a new Phase 2 trial in H1/20 with the optimal dosage(s)."

Two recently launched clinical trials, and related conference calls, were reviewed in an H.C. Wainwright & Co. report.
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Ed Arce, H.C. Wainwright & Co.

"DURECT Corp. announced the initiation of an open-label, 28-day Phase 1b trial of oral DUR-928 in patients with nonalcoholic steatohepatitis. The company plans to enroll about 20 patients per dose group (low, middle, high) for a total of about 60 patients; initial data from this study, including safety, pharmacokinetics and signals of biologic activity, are expected in H2/19."

The company will discuss the trial when it hosts a conference call about this specific disease indication in April.
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This U.S. study follows encouraging results from a Phase 1b trial in the same indication in Australia.
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This California company expects results from clinical trials in liver disease and psoriasis in 2019.
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A drug used to treat schizophrenic patients will launch commercially in February in the U.S.
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More Expert Comments

Experts Following This Company

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Ed Arce, Managing Direction and Senior Research Analyst – H.C. Wainwright & Co.
Francois Brisebois, Healthcare Research Analyst – Laidlaw & Company
Patrick Dolezal – LifeSci Capital
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Brian Marckx, CFA – Zacks Small-Cap Research
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Grant Zeng, Senior Biotech Analyst – Zacks Investment Research, Zacks Small-Cap Research

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Investing Highlights
DUR-928, in Phase 1, is an Endogenous Small Molecule with Compelling Animal Data
Two Late Stage Pain Products Addressing Large Markets
Company Holds the WW Rights to DUR-928 and POSIMIR