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Positive Phase I/II Data of IDX899 Confirm Potent Antiviral Activity and Favorable Safety Profile in Treatment-Naive HIV-Infected Patients
Date:6/12/2008

CAMBRIDGE, Mass., June 12 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, today reported phase I/II data for IDX899, a non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed for the treatment of HIV-1. Patients receiving once-daily IDX899 achieved a mean plasma viral load reduction of approximately 1.8 log(10) after seven days of treatment in each of the 800 mg, 400 mg and 200 mg dosing cohorts. Patients receiving placebo had a 0.05 log10 viral load increase over the same treatment period. No treatment-related serious adverse events were reported for any of the patients receiving IDX899 and no patients discontinued the study. Also, there were no discernable patterns in adverse events between treatment groups and there were no laboratory abnormalities during the treatment period. These data demonstrate potent antiviral activity and a favorable safety profile at all tested doses.

"The profound inhibition of HIV-1 virus replication of IDX899 at doses of 400 and 200 mg daily confirm the potent antiviral activity previously reported at higher doses," said Dr. Robert Murphy, John P. Phair Professor of Infectious Diseases, Director, Global Health Research, Feinberg School of Medicine, Northwestern University. "These early clinical data are very encouraging, showing that IDX899 offers potent viral suppression combined with a promising safety profile."

Study Design

The phase I/II clinical trial was designed to evaluate the safety, tolerability, antiviral activity and pharmacokinetics of IDX899. Three cohorts of 800 mg/day, 400 mg/day and 200 mg/day
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SOURCE Idenix Pharmaceuticals, Inc.
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