DURECT Corporation (Nasdaq: DRRX) today announced that it has initiated a multi-dose Phase 1 clinical trial of an oral formulation of DUR-928, the lead molecule in DURECT's Epigenomic Regulator Program. DUR-928 is an endogenous, small-molecule, new chemical entity (NCE) that may have broad applicability in metabolic diseases such as nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH). It may also play an important role in protecting against acute kidney injury (AKI) and other types of acute organ injury.
"Following the successful completion of our Phase 1 oral, single-dose study of DUR-928, we have now begun enrollment for a Phase 1 multiple-ascending-dose trial," said James E. Brown, President and CEO of DURECT. "This trial will provide valuable information on multi-dose pharmacokinetics that will be important as we continue moving toward Phase 2 planned for next year."
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