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Have You Marked Your Calendar For DURECT?

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Clinical trial results are major catalysts for biotech/pharma companies. Today, we bring to your attention a biopharma stock, which soared 49% on Friday in the run-up to reporting alcoholic hepatitis trial results - DURECT Corporation (DRRX).

The Big Day

DURECT is slated to report preliminary data from its ongoing phase IIa trial evaluating DUR-928 in alcoholic hepatitis on May 7, 2019, after the market close.

The Study

The Phase 2a trial of DUR-928 is a dose escalation study being conducted in two parts - Part A and Part B.

Part A includes patients with moderate alcoholic hepatitis (as determined by MELD scores) and Part B includes patients with severe alcoholic hepatitis.

The study is evaluating intravenously administered three dose levels of DUR-928 - 30 mg, 90 mg and 150 mg in Part A, with sequential dose escalation following review of safety and pharmacokinetics (PK) results of the prior dose level. The dose may be adjusted in Part B based on the findings from Part A.

Alcoholic Hepatitis

Alcoholic hepatitis refers to inflammation of the liver and is associated with a heavy intake of alcohol. Although exact figures are not known, it is estimated that 10-35% of heavy drinkers have alcoholic hepatitis. Medications like corticosteroids and Pentoxifylline are used to treat alcoholic hepatitis.

DUR-928

DUR-928 is the lead product candidate in DURECT's Epigenetic Regulator Program, and is being developed as an oral, injectable and topical formulation. The Company is testing this compound in several hepatic and renal diseases such as nonalcoholic steatohepatitis (NASH), in acute organ injuries such as alcoholic hepatitis and acute kidney injury (AKI), and in inflammatory skin disorders such as psoriasis and atopic dermatitis.

Additional DUR-928 Studies

-- A phase Ib study of oral DUR-928 in patients with NASH is being conducted in the U.S. - with initial data expected in the second half of 2019.
-- A phase IIa proof-of-concept clinical trial of topical DUR-928 in patients with mild to moderate plaque psoriasis is underway - with top-line data anticipated in the second half of 2019.

DRRX has traded in a range of $0.46 to $2.25 in the last 1 year. The stock closed Friday's (May 3) trading at $0.78, up 49.01%.

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