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2010 Dong-A Initiated Phase 3 Program of DA-7218 for Oxazolidinone Antibiotic
2010.09.09

August 31, 2010 Dong-A Initiated Phase 3 Program of DA-7218 for Oxazolidinone Antibiotic

- The first patient has been dosed in Phase 3 clinical study of DA-7218 for the treatment of ABSSSI.



Dong-A Pharmaceutical announced that the first patient has been dosed in its Phase 3 clinical study of the oral
dosage form of DA-7218 for the treatment of acute bacterial skin and skin structure infections (ABSSSI) by Trius
Therapeutics, Inc. Dong-A entered into license-out agreement for DA-7218 with Trius in February 2007.



The enrollment of the first patient into this study, which is the first ABSSSI study initiated under a
Special Protocol Assessment (SPA) under which Trius and the Food and Drug Administration (FDA) have
agreed on new early trial. “Clarity on the clinical and regulatory path afforded by our SPA, which is consistent
with the FDA’s recently issued draft guidance for ABSSSI, coupled with the capital raised in our IPO have
enabled us to move rapidly to initiate our Phase 3 program,” said Jeffrey Stein, Ph.D., President and Chief
Executive Officer of Trius. “Historically, the efficacy of antibiotics has been assessed at the end of therapy. We
believe that the new early primary efficacy assessment at 48-72 hours after initiation of therapy will allow us to
highlight the rapid action of DA-7218, which may offer significant benefits to patients suffering from severe
bacterial infections.”



DA-7218 is an IV and orally administered second generation oxazolidinone for the treatment of serious gram-
positive infections, including vancomycin-resistant enterococcus (VRE), methicillin-resistance Staphylococcus
aureus (MRSA), and penicillin resistant streptococcus pneumonia (PRSP). There is only one approved first
generation oxazolidinone, linezolid, which is currently the leading branded antibiotic for serious gram-positive
infections. As a second generation oxazolidinone, DA-7218 offers a number of important potential advantages
over linezolid, including greater potency, once daily dosing, predictable drug exposure, a shorter course of
therapy, in vivo bactericidal (i.e., bacterial killing) activity, lower frequency of resistance, activity against
linezolid-resistant bacterial strains and an improved safety profile.


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