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Re: DewDiligence post# 94512

Monday, 05/03/2010 6:39:09 PM

Monday, May 03, 2010 6:39:09 PM

Post# of 257257
IDIX 2010-2011 News Flow

[Updated for disclosures on today’s 1Q10 CC.]


HCV

Very soon: Start IDX320 phase-1b monotherapy trial.

Jun 2010: Start drug-drug-interaction study of IDX184+IDX320 in healthy volunteers. (This is a prerequisite for running a phase-2a combination study in HCV patients.)

Mid 2010: Complete IDX184+SoC phase-2a study and IDX184 3-month animal tox. (These two tasks will enable IDX184 to proceed to phase-2b trials that test IDX184+SoC for 12 weeks and provide the first SVR data for IDX184.)

Mid 2010: Start IDX375 phase-1b monotherapy trial.

2H10: Start phase-2a all-oral trial of IDX184+IDX320 in HCV patients. (Positive results from the aforementioned DDI study are a prerequisite for starting the phase-2a trial; the phase-2a duration of treatment will be 14 or 28 days, depending on feedback from the FDA.)

Timing uncertain: Ink IDX184 and/or IDX320 partnerships. (See comments in #msg-49732533.)

Nov 2010/AASLD: Present full phase-2a dataset for IDX184+SoC.

2H10: Select lead NS5A compound. (Start phase-1 trial in 1H11.)


HIV

2Q10: Start IDX899 phase-2b trials in first/second-line settings.*

2H10: Start IDX899 phase-2b “nuke sparing” trial.* (The DDI trial described in #msg-48915175 is a prerequisite.)

*These trials will be conducted by IDIX’s partner, GSK. Please see #msg-47558107 for the trial designs.


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